<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02246998</url>
  </required_header>
  <id_info>
    <org_study_id>GS-US-236-0140</org_study_id>
    <secondary_id>2014-002095-93</secondary_id>
    <nct_id>NCT02246998</nct_id>
  </id_info>
  <brief_title>Renal Effect of Stribild or Other Tenofovir DF-containing Regimens Compared to Ritonavir-boosted Atazanavir Plus Abacavir/Lamivudine in Antiretroviral Treatment-naive HIV-1 Infected Adults</brief_title>
  <official_title>A Randomized, Open Label, Phase 4 Study Evaluating the Renal Effect of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF or Other Tenofovir DF-containing Regimens (Ritonavir-boosted Atazanavir Plus Emtricitabine/Tenofovir DF or Efavirenz/Emtricitabine/Tenofovir DF) Compared to Ritonavir-boosted Atazanavir Plus Abacavir/Lamivudine in Antiretroviral Treatment-naïve HIV-1 Infected Adults With eGFR ≥70 mL/Min</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gilead Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to assess glomerular function before and during&#xD;
      administration of stribild (STB; elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil&#xD;
      fumarate (E/C/F/TDF)) or a regimen containing TDF without cobicistat (COBI) as ritonavir&#xD;
      (RTV)-boosted atazanavir (ATV/r) plus truvada (TVD; FTC/TDF) or atripla (ATR;&#xD;
      efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF)) compared to a regimen&#xD;
      containing neither TDF nor COBI as ATV/r plus abacavir/lamivudine (ABC/3TC) via determination&#xD;
      of actual glomerular filtration rate (aGFR) using iohexol (a probe GFR marker) plasma&#xD;
      clearance and estimated (calculated) glomerular filtration rate (eGFR).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 15, 2014</start_date>
  <completion_date type="Actual">February 17, 2016</completion_date>
  <primary_completion_date type="Actual">January 20, 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Actual Glomerular Filtration Rate (aGFR) Using Iohexol Plasma Clearance (CLiohexol) at Week 24</measure>
    <time_frame>Week 24</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimated GFR (eGFR) Calculated by Cockcroft-Gault Formula at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>GFR is a measure of the rate at which blood is filtered by the kidney. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. eGFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimated GFR Calculated by Modification of Diet in Renal Disease (MDRD) Formula at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. eGFR (mL/min/1.73 m^2) = 186 * (Scr)^-1.154 * (Age)^(-0.203) * (0.742 if female) * (1.212 if black). Scr = serum creatinine in mg/dL</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)</measure>
    <time_frame>Up to 24 weeks plus 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)</measure>
    <time_frame>Up to 24 weeks plus 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage Change From Baseline in Urine Albumin to Creatinine Ratio (mg/g) at Week 24</measure>
    <time_frame>Baseline; Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage Change From Baseline in Urine Protein to Creatinine Ratio (mg/g) at Week 24</measure>
    <time_frame>Baseline; Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage Change From Baseline in Urine β2-microglobulin to Creatinine Ratio (µg/g) at Week 24</measure>
    <time_frame>Baseline; Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio (µg/g) at Week 24</measure>
    <time_frame>Baseline; Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic (PK) Parameter: Cmax for COBI</measure>
    <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
    <description>Cmax is defined as the maximum observed concentration of drug in plasma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: Tmax for COBI</measure>
    <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
    <description>Tmax is defined as the time of Cmax.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: Clast for COBI</measure>
    <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
    <description>Clast is defined as the last observable concentration of drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: Tlast for COBI</measure>
    <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
    <description>Tlast is defined as the time of Clast.&#xD;
Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: Ctau for COBI</measure>
    <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
    <description>Ctau is defined as the observed drug concentration at the end of the dosing interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: λz for COBI</measure>
    <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
    <description>λz is defined as the terminal elimination rate constant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: AUCtau for COBI</measure>
    <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
    <description>AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: t1/2 for COBI</measure>
    <time_frame>Predose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
    <description>t1/2 is defined as the estimate of the terminal elimination half-life of the drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: Cmax for RTV</measure>
    <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: Tmax for RTV</measure>
    <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: Clast for RTV</measure>
    <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: Tlast for RTV</measure>
    <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
    <description>Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: Ctau for RTV</measure>
    <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: AUCtau for RTV</measure>
    <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: λz for RTV</measure>
    <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: t1/2 for RTV</measure>
    <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: Cmax for TFV</measure>
    <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: Tmax for TFV</measure>
    <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: Clast for TFV</measure>
    <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: Tlast for TFV</measure>
    <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
    <description>Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: Ctau for TFV</measure>
    <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: λz for TFV</measure>
    <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: AUCtau for TFV</measure>
    <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: t1/2 for TFV</measure>
    <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: AUCinf for Iohexol</measure>
    <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; on Day 1 and Weeks 4, 8, 16, and 24</time_frame>
    <description>AUC inf is defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HIV-1 RNA &lt; 50 Copies/mL Week 24 as Determined by Snapshot Algorithm</measure>
    <time_frame>Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 24</measure>
    <time_frame>Baseline; Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Experiencing Adverse Events (AEs)</measure>
    <time_frame>Up to the last dose date plus 30 days (Up to 24 weeks plus 30 days)</time_frame>
    <description>Incidences of adverse events and laboratory abnormalities will be summarized.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory Abnormalities</measure>
    <time_frame>Up to the last dose date plus 30 days (Up to 24 weeks plus 30 days)</time_frame>
    <description>Graded laboratory abnormalities were defined as values that increased at least one toxicity grade from predose at any postdose up to the last dose date of study drug plus 30 days. The most severe graded abnormality from all tests was counted for each participant.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>HIV-1 Infection</condition>
  <arm_group>
    <arm_group_label>STB+iohexol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive STB+iohexol for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RTV+ATV+TVD+iohexol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive RTV+ATV+TVD+iohexol for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ATR+iohexol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive ATR+iohexol for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RTV+ATV+ABC/3TC+iohexol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive RTV+ATV+ABC/3TC+iohexol for 24 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>STB</intervention_name>
    <description>150/150/200/300 mg fixed dose combination (FDC) tablet administered orally once daily with food</description>
    <arm_group_label>STB+iohexol</arm_group_label>
    <other_name>Stribild®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TVD</intervention_name>
    <description>200/300 mg FDC tablet administered orally once daily with food</description>
    <arm_group_label>RTV+ATV+TVD+iohexol</arm_group_label>
    <other_name>Truvada®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ATR</intervention_name>
    <description>600/200/300 mg FDC tablet administered orally once daily on an empty stomach at bedtime</description>
    <arm_group_label>ATR+iohexol</arm_group_label>
    <other_name>Atripla®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RTV</intervention_name>
    <description>100 mg tablet administered orally once daily with food</description>
    <arm_group_label>RTV+ATV+ABC/3TC+iohexol</arm_group_label>
    <arm_group_label>RTV+ATV+TVD+iohexol</arm_group_label>
    <other_name>Norvir®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ATV</intervention_name>
    <description>300 mg capsule administered orally once daily with food</description>
    <arm_group_label>RTV+ATV+ABC/3TC+iohexol</arm_group_label>
    <arm_group_label>RTV+ATV+TVD+iohexol</arm_group_label>
    <other_name>Reyataz®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABC/3TC</intervention_name>
    <description>600/300 mg FDC tablet administered orally once daily with food</description>
    <arm_group_label>RTV+ATV+ABC/3TC+iohexol</arm_group_label>
    <other_name>Kivexa®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Iohexol</intervention_name>
    <description>1500 mg solution administered intravenously at baseline, and at Weeks 4, 8, 16, and 24</description>
    <arm_group_label>ATR+iohexol</arm_group_label>
    <arm_group_label>RTV+ATV+ABC/3TC+iohexol</arm_group_label>
    <arm_group_label>RTV+ATV+TVD+iohexol</arm_group_label>
    <arm_group_label>STB+iohexol</arm_group_label>
    <other_name>Omnipaque™</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Treatment naïve&#xD;
&#xD;
          -  Plasma HIV-1 RNA levels ≥ 5,000 copies/mL at Screening&#xD;
&#xD;
          -  CD4 cell count &gt; 200 cells/µL&#xD;
&#xD;
          -  Screening genotype report provided by the site must show sensitivity to FTC, TDF, EFV,&#xD;
             ABC, 3TC, ATV and absence of study drug resistance mutations that include K65R, K70E&#xD;
             and M184V in RT&#xD;
&#xD;
          -  Estimated GFR ≥ 70 mL/min&#xD;
&#xD;
          -  Hepatic transaminases (aspartate aminotransferase [AST] and alanine aminotransferase&#xD;
             [ALT]) ≤ 5 × upper limit of normal (ULN)&#xD;
&#xD;
          -  Total bilirubin ≤ 1.5 mg/dL (≤ 26 umol/L), or normal direct bilirubin&#xD;
&#xD;
          -  Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm^3; platelets ≥&#xD;
             50,000/mm^3; hemoglobin ≥ 8.5 g/dL)&#xD;
&#xD;
          -  Serum amylase ≤ 5 × ULN (individuals with serum amylase &gt; 5 × ULN will remain eligible&#xD;
             if serum lipase is ≤ 5 × ULN)&#xD;
&#xD;
          -  Normal electrocardiogram (ECG) or not clinically significant if abnormal ECG&#xD;
&#xD;
          -  Not pregnant or non-lactating females of non-childbearing potential. Or females with&#xD;
             childbearing potential who agree to utilize highly effective contraception methods or&#xD;
             be non-heterosexually active or practice sexual abstinence from screening throughout&#xD;
             the duration of study treatment and for 90 days if taking EFV/FTC/TDF or for 30 days&#xD;
             for all other study drugs following the last study drug dose&#xD;
&#xD;
          -  Males who agree to utilize a highly effective method of contraception during&#xD;
             heterosexual intercourse or be non-heterosexually active, or practice sexual&#xD;
             abstinence from first dose throughout the study period and for 90 days if taking&#xD;
             EFV/FTC/TDF or for 30 days for all other study drugs following the last study drug&#xD;
             dose. Males who agree to refrain from sperm donation from first dose until at least 90&#xD;
             days if taking EFV/FTC/TDF or for 30 days for all other study drugs following the last&#xD;
             study drug dose&#xD;
&#xD;
          -  Body mass index (BMI) of 19 ≤ BMI ≤ 30 kg/m^2 and body weight ≥ 40 kg&#xD;
&#xD;
          -  Life expectancy ≥ 1 year&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  HLA-B*5701 allele positive&#xD;
&#xD;
          -  A new AIDS-defining condition diagnosed within the 30 days prior to screening&#xD;
&#xD;
          -  Hepatitis B surface antigen (HBsAg) positive&#xD;
&#xD;
          -  Hepatitis C virus (HCV) antibody positive and HCV RNA detectable&#xD;
&#xD;
          -  Individuals experiencing decompensated cirrhosis&#xD;
&#xD;
          -  Females who are breastfeeding&#xD;
&#xD;
          -  Positive serum pregnancy test&#xD;
&#xD;
          -  Have an implanted defibrillator or pacemaker&#xD;
&#xD;
          -  Current alcohol or substance that could potentially interfere with study compliance&#xD;
&#xD;
          -  A history of malignancy within the past 5 years (prior to screening) or ongoing&#xD;
             malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or&#xD;
             resected, non-invasive cutaneous squamous carcinoma. Individuals with cutaneous KS are&#xD;
             eligible, but must not have received any systemic therapy for KS within 30 days of Day&#xD;
             1 Visit and must not be anticipated to require systemic therapy during the study&#xD;
&#xD;
          -  Active, serious infections (other than HIV-1 infection) requiring parenteral&#xD;
             antibiotic or antifungal therapy within 30 days prior to Day 1 Visit&#xD;
&#xD;
        Note: Other protocol defined Inclusion/Exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gilead Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Gilead Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ghent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tourcoing</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seville</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bournemouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brighton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bristol</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Coventry</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Newcastle</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sheffield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
    <country>Ireland</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <results_first_submitted>January 20, 2017</results_first_submitted>
  <results_first_submitted_qc>December 1, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">January 3, 2018</results_first_posted>
  <last_update_submitted>December 1, 2017</last_update_submitted>
  <last_update_submitted_qc>December 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled at study sites in Belgium, Ireland, Spain, and the United Kingdom. The first participant was screened on 15 Dec 2014. The last study visit occurred on 17 February 2016.</recruitment_details>
      <pre_assignment_details>93 participants were screened.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>STB + Iohexol</title>
          <description>Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (STB; Stribild®; EVG/COBI/FTC/TDF; 150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
        </group>
        <group group_id="P2">
          <title>TVD + ATV/r + Iohexol</title>
          <description>FTC/TDF (TVD; Truvada®; 200/300 mg) FDC tablet + Atazanavir (ATV) 300 mg capsule + Ritonavir (RTV) 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
        </group>
        <group group_id="P3">
          <title>ATR + Iohexol</title>
          <description>EFV/FTC/TDF (ATR; Atripla® 600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
        </group>
        <group group_id="P4">
          <title>ABC/3TC + ATV/r + Iohexol</title>
          <description>ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="18"/>
                <participants group_id="P4" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized but Never Dosed</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Analysis Set: all randomized participants who received at least 1 dose of study drug, excluding iohexol</population>
      <group_list>
        <group group_id="B1">
          <title>STB + Iohexol</title>
          <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
        </group>
        <group group_id="B2">
          <title>TVD + ATV/r + Iohexol</title>
          <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
        </group>
        <group group_id="B3">
          <title>ATR + Iohexol</title>
          <description>ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
        </group>
        <group group_id="B4">
          <title>ABC/3TC + ATV/r + Iohexol</title>
          <description>ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="17"/>
            <count group_id="B2" value="16"/>
            <count group_id="B3" value="16"/>
            <count group_id="B4" value="17"/>
            <count group_id="B5" value="66"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36" spread="8.1"/>
                    <measurement group_id="B2" value="34" spread="8.4"/>
                    <measurement group_id="B3" value="34" spread="9.6"/>
                    <measurement group_id="B4" value="34" spread="7.5"/>
                    <measurement group_id="B5" value="35" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ireland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Actual Glomerular Filtration Rate</title>
          <units>mL/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="111.8" spread="31.07"/>
                    <measurement group_id="B2" value="112.0" spread="19.17"/>
                    <measurement group_id="B3" value="105.4" spread="38.22"/>
                    <measurement group_id="B4" value="96.6" spread="34.52"/>
                    <measurement group_id="B5" value="106.4" spread="31.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Estimated Glomerular Filtration Rate by Cockcroft-Gault</title>
          <units>mL/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="120.8" spread="13.94"/>
                    <measurement group_id="B2" value="121.2" spread="24.34"/>
                    <measurement group_id="B3" value="119.5" spread="20.36"/>
                    <measurement group_id="B4" value="122.6" spread="20.25"/>
                    <measurement group_id="B5" value="121.0" spread="19.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Estimated Glomerular Filtration Rate by MDRD Formula</title>
          <units>mL/min/1.73m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="103.8" spread="14.06"/>
                    <measurement group_id="B2" value="110.6" spread="18.47"/>
                    <measurement group_id="B3" value="108.4" spread="21.42"/>
                    <measurement group_id="B4" value="105.5" spread="12.59"/>
                    <measurement group_id="B5" value="107.0" spread="16.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>CD4 Cell Count</title>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="552" spread="177.8"/>
                    <measurement group_id="B2" value="600" spread="217.9"/>
                    <measurement group_id="B3" value="553" spread="215.8"/>
                    <measurement group_id="B4" value="524" spread="190.0"/>
                    <measurement group_id="B5" value="557" spread="197.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Actual Glomerular Filtration Rate (aGFR) Using Iohexol Plasma Clearance (CLiohexol) at Week 24</title>
        <time_frame>Week 24</time_frame>
        <population>Participants in the pharmacodynamics (PD) analysis Set (all treated participants in each group, who have evaluable baseline and at least 1 postbaseline aGFR and /or eGFR at any visit) with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O3">
            <title>ATR + Iohexol</title>
            <description>ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O4">
            <title>ABC/3TC + ATV/r + Iohexol</title>
            <description>ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>Actual Glomerular Filtration Rate (aGFR) Using Iohexol Plasma Clearance (CLiohexol) at Week 24</title>
          <population>Participants in the pharmacodynamics (PD) analysis Set (all treated participants in each group, who have evaluable baseline and at least 1 postbaseline aGFR and /or eGFR at any visit) with available data were analyzed.</population>
          <units>mL/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103.6" spread="23.28"/>
                    <measurement group_id="O2" value="104.9" spread="27.16"/>
                    <measurement group_id="O3" value="111.1" spread="23.23"/>
                    <measurement group_id="O4" value="101.0" spread="27.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Estimated GFR (eGFR) Calculated by Cockcroft-Gault Formula at Week 24</title>
        <description>GFR is a measure of the rate at which blood is filtered by the kidney. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. eGFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL</description>
        <time_frame>Week 24</time_frame>
        <population>Participants in the PD Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O3">
            <title>ATR + Iohexol</title>
            <description>ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O4">
            <title>ABC/3TC + ATV/r + Iohexol</title>
            <description>ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>Estimated GFR (eGFR) Calculated by Cockcroft-Gault Formula at Week 24</title>
          <description>GFR is a measure of the rate at which blood is filtered by the kidney. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. eGFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL</description>
          <population>Participants in the PD Analysis Set with available data were analyzed.</population>
          <units>mL/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="116.9" spread="17.06"/>
                    <measurement group_id="O2" value="122.4" spread="31.71"/>
                    <measurement group_id="O3" value="120.0" spread="20.52"/>
                    <measurement group_id="O4" value="123.0" spread="25.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Estimated GFR Calculated by Modification of Diet in Renal Disease (MDRD) Formula at Week 24</title>
        <description>MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. eGFR (mL/min/1.73 m^2) = 186 * (Scr)^-1.154 * (Age)^(-0.203) * (0.742 if female) * (1.212 if black). Scr = serum creatinine in mg/dL</description>
        <time_frame>Week 24</time_frame>
        <population>Participants in the PD Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O3">
            <title>ATR + Iohexol</title>
            <description>ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O4">
            <title>ABC/3TC + ATV/r + Iohexol</title>
            <description>ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>Estimated GFR Calculated by Modification of Diet in Renal Disease (MDRD) Formula at Week 24</title>
          <description>MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. eGFR (mL/min/1.73 m^2) = 186 * (Scr)^-1.154 * (Age)^(-0.203) * (0.742 if female) * (1.212 if black). Scr = serum creatinine in mg/dL</description>
          <population>Participants in the PD Analysis Set with available data were analyzed.</population>
          <units>mL/min/1.73m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.3" spread="17.07"/>
                    <measurement group_id="O2" value="110.2" spread="23.98"/>
                    <measurement group_id="O3" value="109.2" spread="20.90"/>
                    <measurement group_id="O4" value="104.9" spread="12.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)</title>
        <time_frame>Up to 24 weeks plus 30 days</time_frame>
        <population>Safety Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O3">
            <title>ATR + Iohexol</title>
            <description>ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O4">
            <title>ABC/3TC + ATV/r + Iohexol</title>
            <description>ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)</title>
          <population>Safety Analysis Set</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Grade</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)</title>
        <time_frame>Up to 24 weeks plus 30 days</time_frame>
        <population>Participants in the Safety Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O3">
            <title>ATR + Iohexol</title>
            <description>ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O4">
            <title>ABC/3TC + ATV/r + Iohexol</title>
            <description>ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)</title>
          <population>Participants in the Safety Analysis Set with available data were analyzed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 1 (Hyperglycemia)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8"/>
                    <measurement group_id="O2" value="12.5"/>
                    <measurement group_id="O3" value="20.0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 1 (Hypoglycemia)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2 (Hyperglycemia)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2 (Hypoglycemia)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6.3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 (Hyperglycemia)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 (Hypoglycemia)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 (Hyperglycemia)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 (Hypoglycemia)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any grade (Hyperglycemia)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8"/>
                    <measurement group_id="O2" value="12.5"/>
                    <measurement group_id="O3" value="20.0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any grade (Hypoglycemia)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6.3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage Change From Baseline in Urine Albumin to Creatinine Ratio (mg/g) at Week 24</title>
        <time_frame>Baseline; Week 24</time_frame>
        <population>Participants in the PD Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O3">
            <title>ATR + Iohexol</title>
            <description>ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O4">
            <title>ABC/3TC + ATV/r + Iohexol</title>
            <description>ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change From Baseline in Urine Albumin to Creatinine Ratio (mg/g) at Week 24</title>
          <population>Participants in the PD Analysis Set with available data were analyzed.</population>
          <units>percentage change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-23.6" upper_limit="50.0"/>
                    <measurement group_id="O2" value="-18.3" lower_limit="-57.1" upper_limit="50.0"/>
                    <measurement group_id="O3" value="50.0" lower_limit="-25.0" upper_limit="100.0"/>
                    <measurement group_id="O4" value="-16.7" lower_limit="-37.5" upper_limit="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage Change From Baseline in Urine Protein to Creatinine Ratio (mg/g) at Week 24</title>
        <time_frame>Baseline; Week 24</time_frame>
        <population>Participants in the PD Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O3">
            <title>ATR + Iohexol</title>
            <description>ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O4">
            <title>ABC/3TC + ATV/r + Iohexol</title>
            <description>ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change From Baseline in Urine Protein to Creatinine Ratio (mg/g) at Week 24</title>
          <population>Participants in the PD Analysis Set with available data were analyzed.</population>
          <units>percentage change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" lower_limit="-11.0" upper_limit="22.5"/>
                    <measurement group_id="O2" value="17.5" lower_limit="0.0" upper_limit="45.7"/>
                    <measurement group_id="O3" value="-10.5" lower_limit="-41.9" upper_limit="69.8"/>
                    <measurement group_id="O4" value="7.1" lower_limit="-24.3" upper_limit="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage Change From Baseline in Urine β2-microglobulin to Creatinine Ratio (µg/g) at Week 24</title>
        <time_frame>Baseline; Week 24</time_frame>
        <population>Participants in the PD Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O3">
            <title>ATR + Iohexol</title>
            <description>ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O4">
            <title>ABC/3TC + ATV/r + Iohexol</title>
            <description>ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change From Baseline in Urine β2-microglobulin to Creatinine Ratio (µg/g) at Week 24</title>
          <population>Participants in the PD Analysis Set with available data were analyzed.</population>
          <units>percentage change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.1" lower_limit="-48.2" upper_limit="22.8"/>
                    <measurement group_id="O2" value="197.3" lower_limit="21.7" upper_limit="328.7"/>
                    <measurement group_id="O3" value="-1.1" lower_limit="-33.1" upper_limit="36.7"/>
                    <measurement group_id="O4" value="-22.7" lower_limit="-60.8" upper_limit="-6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio (µg/g) at Week 24</title>
        <time_frame>Baseline; Week 24</time_frame>
        <population>Participants in the PD Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O3">
            <title>ATR + Iohexol</title>
            <description>ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O4">
            <title>ABC/3TC + ATV/r + Iohexol</title>
            <description>ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio (µg/g) at Week 24</title>
          <population>Participants in the PD Analysis Set with available data were analyzed.</population>
          <units>percentage change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.1" lower_limit="-1.1" upper_limit="51.1"/>
                    <measurement group_id="O2" value="52.2" lower_limit="5.9" upper_limit="147.6"/>
                    <measurement group_id="O3" value="52.1" lower_limit="-33.8" upper_limit="92.8"/>
                    <measurement group_id="O4" value="4.8" lower_limit="-13.6" upper_limit="15.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetic (PK) Parameter: Cmax for COBI</title>
        <description>Cmax is defined as the maximum observed concentration of drug in plasma.</description>
        <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
        <population>Participants in the COBI PK Analysis Set (all treated participants who have respective, evaluable PK profiles of COBI) with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic (PK) Parameter: Cmax for COBI</title>
          <description>Cmax is defined as the maximum observed concentration of drug in plasma.</description>
          <population>Participants in the COBI PK Analysis Set (all treated participants who have respective, evaluable PK profiles of COBI) with available data were analyzed.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1189.1" spread="377.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1017.8" spread="388.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1197.3" spread="656.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1123.4" spread="430.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: Tmax for COBI</title>
        <description>Tmax is defined as the time of Cmax.</description>
        <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
        <population>Participants in the COBI PK Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: Tmax for COBI</title>
          <description>Tmax is defined as the time of Cmax.</description>
          <population>Participants in the COBI PK Analysis Set with available data were analyzed.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" lower_limit="3.0" upper_limit="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" lower_limit="3.0" upper_limit="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" lower_limit="2.1" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="2.1" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: Clast for COBI</title>
        <description>Clast is defined as the last observable concentration of drug.</description>
        <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
        <population>Participants in the COBI PK Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: Clast for COBI</title>
          <description>Clast is defined as the last observable concentration of drug.</description>
          <population>Participants in the COBI PK Analysis Set with available data were analyzed.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.0" spread="126.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.5" spread="59.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="214.0" spread="693.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="162.7" spread="299.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: Tlast for COBI</title>
        <description>Tlast is defined as the time of Clast.&#xD;
Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.</description>
        <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
        <population>Participants in the COBI PK Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: Tlast for COBI</title>
          <description>Tlast is defined as the time of Clast.&#xD;
Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.</description>
          <population>Participants in the COBI PK Analysis Set with available data were analyzed.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0" lower_limit="24.0" upper_limit="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0" lower_limit="24.0" upper_limit="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0" lower_limit="24.0" upper_limit="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0" lower_limit="10.1" upper_limit="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: Ctau for COBI</title>
        <description>Ctau is defined as the observed drug concentration at the end of the dosing interval.</description>
        <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
        <population>Participants in the COBI PK Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: Ctau for COBI</title>
          <description>Ctau is defined as the observed drug concentration at the end of the dosing interval.</description>
          <population>Participants in the COBI PK Analysis Set with available data were analyzed.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.7" spread="113.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.0" spread="28.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="198.3" spread="697.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.7" spread="285.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: λz for COBI</title>
        <description>λz is defined as the terminal elimination rate constant.</description>
        <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
        <population>Participants in the COBI PK Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: λz for COBI</title>
          <description>λz is defined as the terminal elimination rate constant.</description>
          <population>Participants in the COBI PK Analysis Set with available data were analyzed.</population>
          <units>1/hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.179" spread="0.0598"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.192" spread="0.0481"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.206" spread="0.0610"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.211" spread="0.0844"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: AUCtau for COBI</title>
        <description>AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).</description>
        <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
        <population>Participants in the COBI PK Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: AUCtau for COBI</title>
          <description>AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).</description>
          <population>Participants in the COBI PK Analysis Set with available data were analyzed.</population>
          <units>h*ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9225.8" spread="2786.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8127.4" spread="3217.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10684.8" spread="12567.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8391.3" spread="6132.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: t1/2 for COBI</title>
        <description>t1/2 is defined as the estimate of the terminal elimination half-life of the drug.</description>
        <time_frame>Predose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
        <population>Participants in the COBI PK Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: t1/2 for COBI</title>
          <description>t1/2 is defined as the estimate of the terminal elimination half-life of the drug.</description>
          <population>Participants in the COBI PK Analysis Set with available data were analyzed.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.80" lower_limit="3.24" upper_limit="4.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.09" lower_limit="2.89" upper_limit="4.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.42" lower_limit="2.91" upper_limit="4.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.24" lower_limit="2.57" upper_limit="4.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: Cmax for RTV</title>
        <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
        <population>Participants in the RTV PK Analysis Set (all treated participants who have respective, evaluable PK profiles of RTV) with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>ABC/3TC + ATV/r + Iohexol</title>
            <description>ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: Cmax for RTV</title>
          <population>Participants in the RTV PK Analysis Set (all treated participants who have respective, evaluable PK profiles of RTV) with available data were analyzed.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1260.0" spread="453.58"/>
                    <measurement group_id="O2" value="1352.1" spread="513.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1142.3" spread="489.18"/>
                    <measurement group_id="O2" value="1326.2" spread="493.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1144.8" spread="416.41"/>
                    <measurement group_id="O2" value="1557.6" spread="555.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1217.7" spread="445.18"/>
                    <measurement group_id="O2" value="1485.4" spread="662.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: Tmax for RTV</title>
        <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
        <population>Participants in the RTV PK Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>ABC/3TC + ATV/r + Iohexol</title>
            <description>ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: Tmax for RTV</title>
          <population>Participants in the RTV PK Analysis Set with available data were analyzed.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="3.2" upper_limit="4.6"/>
                    <measurement group_id="O2" value="4.0" lower_limit="2.1" upper_limit="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="2.5" upper_limit="5.1"/>
                    <measurement group_id="O2" value="4.0" lower_limit="3.0" upper_limit="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" lower_limit="3.0" upper_limit="5.1"/>
                    <measurement group_id="O2" value="4.0" lower_limit="2.2" upper_limit="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="3.0" upper_limit="5.0"/>
                    <measurement group_id="O2" value="4.0" lower_limit="3.0" upper_limit="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: Clast for RTV</title>
        <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
        <population>Participants in the RTV PK Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>ABC/3TC + ATV/r + Iohexol</title>
            <description>ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: Clast for RTV</title>
          <population>Participants in the RTV PK Analysis Set with available data were analyzed.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.5" spread="57.85"/>
                    <measurement group_id="O2" value="61.0" spread="56.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.0" spread="91.24"/>
                    <measurement group_id="O2" value="85.5" spread="99.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.2" spread="49.85"/>
                    <measurement group_id="O2" value="99.1" spread="92.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102.5" spread="182.16"/>
                    <measurement group_id="O2" value="187.9" spread="258.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: Tlast for RTV</title>
        <description>Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.</description>
        <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
        <population>Participants in the RTV PK Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>ABC/3TC + ATV/r + Iohexol</title>
            <description>ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: Tlast for RTV</title>
          <description>Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.</description>
          <population>Participants in the RTV PK Analysis Set with available data were analyzed.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0" lower_limit="24.0" upper_limit="24.0"/>
                    <measurement group_id="O2" value="24.0" lower_limit="24.0" upper_limit="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0" lower_limit="24.0" upper_limit="24.0"/>
                    <measurement group_id="O2" value="24.0" lower_limit="24.0" upper_limit="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0" lower_limit="24.0" upper_limit="24.0"/>
                    <measurement group_id="O2" value="24.0" lower_limit="24.0" upper_limit="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0" lower_limit="24.0" upper_limit="24.0"/>
                    <measurement group_id="O2" value="24.0" lower_limit="24.0" upper_limit="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: Ctau for RTV</title>
        <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
        <population>Participants in the RTV PK Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>ABC/3TC + ATV/r + Iohexol</title>
            <description>ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: Ctau for RTV</title>
          <population>Participants in the RTV PK Analysis Set with available data were analyzed.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.5" spread="57.85"/>
                    <measurement group_id="O2" value="61.0" spread="56.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.0" spread="91.24"/>
                    <measurement group_id="O2" value="85.5" spread="99.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.2" spread="49.85"/>
                    <measurement group_id="O2" value="99.1" spread="92.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102.5" spread="182.16"/>
                    <measurement group_id="O2" value="157.0" spread="246.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: AUCtau for RTV</title>
        <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
        <population>Participants in the RTV PK Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>ABC/3TC + ATV/r + Iohexol</title>
            <description>ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: AUCtau for RTV</title>
          <population>Participants in the RTV PK Analysis Set with available data were analyzed.</population>
          <units>h*ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8259.6" spread="3166.47"/>
                    <measurement group_id="O2" value="9649.1" spread="3713.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8362.0" spread="3544.53"/>
                    <measurement group_id="O2" value="9702.2" spread="3391.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8102.6" spread="3392.00"/>
                    <measurement group_id="O2" value="11148.0" spread="4482.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8907.0" spread="5182.65"/>
                    <measurement group_id="O2" value="12039.3" spread="6792.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: λz for RTV</title>
        <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
        <population>Participants in the RTV PK Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>ABC/3TC + ATV/r + Iohexol</title>
            <description>ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: λz for RTV</title>
          <population>Participants in the RTV PK Analysis Set with available data were analyzed.</population>
          <units>1/hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.156" spread="0.0386"/>
                    <measurement group_id="O2" value="0.151" spread="0.0346"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.144" spread="0.0474"/>
                    <measurement group_id="O2" value="0.142" spread="0.0281"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.138" spread="0.0382"/>
                    <measurement group_id="O2" value="0.131" spread="0.0291"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.133" spread="0.0347"/>
                    <measurement group_id="O2" value="0.128" spread="0.0469"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: t1/2 for RTV</title>
        <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
        <population>Participants in the RTV PK Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>ABC/3TC + ATV/r + Iohexol</title>
            <description>ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: t1/2 for RTV</title>
          <population>Participants in the RTV PK Analysis Set with available data were analyzed.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.56" lower_limit="3.77" upper_limit="4.99"/>
                    <measurement group_id="O2" value="4.53" lower_limit="3.83" upper_limit="6.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.85" lower_limit="3.75" upper_limit="5.34"/>
                    <measurement group_id="O2" value="4.68" lower_limit="4.31" upper_limit="5.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.39" lower_limit="4.22" upper_limit="6.22"/>
                    <measurement group_id="O2" value="5.57" lower_limit="4.68" upper_limit="6.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.08" lower_limit="4.49" upper_limit="5.78"/>
                    <measurement group_id="O2" value="4.82" lower_limit="4.25" upper_limit="6.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: Cmax for TFV</title>
        <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
        <population>Participants in the TFV PK Analysis Set (all treated participants who have respective, evaluable PK profiles of TFV) with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O3">
            <title>ATR + Iohexol</title>
            <description>ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: Cmax for TFV</title>
          <population>Participants in the TFV PK Analysis Set (all treated participants who have respective, evaluable PK profiles of TFV) with available data were analyzed.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="371.2" spread="94.46"/>
                    <measurement group_id="O2" value="301.6" spread="116.36"/>
                    <measurement group_id="O3" value="298.3" spread="100.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="379.8" spread="87.44"/>
                    <measurement group_id="O2" value="343.0" spread="133.97"/>
                    <measurement group_id="O3" value="325.5" spread="149.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="399.5" spread="169.51"/>
                    <measurement group_id="O2" value="319.4" spread="146.41"/>
                    <measurement group_id="O3" value="298.6" spread="107.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="394.4" spread="131.09"/>
                    <measurement group_id="O2" value="350.7" spread="126.91"/>
                    <measurement group_id="O3" value="305.9" spread="106.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: Tmax for TFV</title>
        <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
        <population>Participants in the TFV PK Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O3">
            <title>ATR + Iohexol</title>
            <description>ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: Tmax for TFV</title>
          <population>Participants in the TFV PK Analysis Set with available data were analyzed.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.3" upper_limit="3.1"/>
                    <measurement group_id="O2" value="3.0" lower_limit="1.5" upper_limit="3.1"/>
                    <measurement group_id="O3" value="1.1" lower_limit="0.6" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="2.0" upper_limit="2.1"/>
                    <measurement group_id="O2" value="3.0" lower_limit="2.0" upper_limit="3.1"/>
                    <measurement group_id="O3" value="1.0" lower_limit="0.6" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" lower_limit="1.1" upper_limit="3.1"/>
                    <measurement group_id="O2" value="2.1" lower_limit="1.0" upper_limit="3.1"/>
                    <measurement group_id="O3" value="1.2" lower_limit="1.0" upper_limit="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.1" upper_limit="3.0"/>
                    <measurement group_id="O2" value="2.1" lower_limit="1.1" upper_limit="3.2"/>
                    <measurement group_id="O3" value="1.1" lower_limit="0.6" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: Clast for TFV</title>
        <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
        <population>Participants in the TFV PK Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O3">
            <title>ATR + Iohexol</title>
            <description>ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: Clast for TFV</title>
          <population>Participants in the TFV PK Analysis Set with available data were analyzed.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.1" spread="32.41"/>
                    <measurement group_id="O2" value="73.1" spread="23.74"/>
                    <measurement group_id="O3" value="55.4" spread="15.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.9" spread="35.12"/>
                    <measurement group_id="O2" value="78.2" spread="31.27"/>
                    <measurement group_id="O3" value="53.4" spread="18.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="128.5" spread="184.17"/>
                    <measurement group_id="O2" value="74.5" spread="26.01"/>
                    <measurement group_id="O3" value="63.0" spread="19.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.5" spread="53.04"/>
                    <measurement group_id="O2" value="87.3" spread="41.20"/>
                    <measurement group_id="O3" value="58.5" spread="16.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: Tlast for TFV</title>
        <description>Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.</description>
        <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
        <population>Participants in the TFV PK Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O3">
            <title>ATR + Iohexol</title>
            <description>ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: Tlast for TFV</title>
          <description>Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.</description>
          <population>Participants in the TFV PK Analysis Set with available data were analyzed.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0" lower_limit="24.0" upper_limit="24.0"/>
                    <measurement group_id="O2" value="24.0" lower_limit="24.0" upper_limit="24.0"/>
                    <measurement group_id="O3" value="24.0" lower_limit="24.0" upper_limit="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0" lower_limit="24.0" upper_limit="24.0"/>
                    <measurement group_id="O2" value="24.0" lower_limit="24.0" upper_limit="24.0"/>
                    <measurement group_id="O3" value="24.0" lower_limit="24.0" upper_limit="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0" lower_limit="24.0" upper_limit="24.0"/>
                    <measurement group_id="O2" value="24.0" lower_limit="24.0" upper_limit="24.0"/>
                    <measurement group_id="O3" value="24.0" lower_limit="24.0" upper_limit="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0" lower_limit="24.0" upper_limit="24.0"/>
                    <measurement group_id="O2" value="24.0" lower_limit="24.0" upper_limit="24.0"/>
                    <measurement group_id="O3" value="24.0" lower_limit="24.0" upper_limit="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: Ctau for TFV</title>
        <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
        <population>Participants in the TFV PK Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O3">
            <title>ATR + Iohexol</title>
            <description>ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: Ctau for TFV</title>
          <population>Participants in the TFV PK Analysis Set with available data were analyzed.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.6" spread="36.88"/>
                    <measurement group_id="O2" value="73.1" spread="23.74"/>
                    <measurement group_id="O3" value="55.4" spread="15.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.8" spread="40.16"/>
                    <measurement group_id="O2" value="78.2" spread="31.27"/>
                    <measurement group_id="O3" value="48.8" spread="23.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="128.5" spread="184.17"/>
                    <measurement group_id="O2" value="74.5" spread="26.01"/>
                    <measurement group_id="O3" value="57.5" spread="24.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.7" spread="57.06"/>
                    <measurement group_id="O2" value="77.3" spread="43.06"/>
                    <measurement group_id="O3" value="54.2" spread="22.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: λz for TFV</title>
        <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
        <population>Participants in the TFV PK Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O3">
            <title>ATR + Iohexol</title>
            <description>ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: λz for TFV</title>
          <population>Participants in the TFV PK Analysis Set with available data were analyzed.</population>
          <units>1/hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.045" spread="0.0148"/>
                    <measurement group_id="O2" value="0.048" spread="0.0059"/>
                    <measurement group_id="O3" value="0.037" spread="0.0133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.051" spread="0.0167"/>
                    <measurement group_id="O2" value="0.048" spread="0.0158"/>
                    <measurement group_id="O3" value="0.041" spread="0.0197"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.047" spread="0.0173"/>
                    <measurement group_id="O2" value="0.047" spread="0.0115"/>
                    <measurement group_id="O3" value="0.033" spread="0.0166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.051" spread="0.0195"/>
                    <measurement group_id="O2" value="0.046" spread="0.0184"/>
                    <measurement group_id="O3" value="0.035" spread="0.0138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: AUCtau for TFV</title>
        <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
        <population>Participants in the TFV PK Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O3">
            <title>ATR + Iohexol</title>
            <description>ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: AUCtau for TFV</title>
          <population>Participants in the TFV PK Analysis Set with available data were analyzed.</population>
          <units>h*ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3370.2" spread="1000.75"/>
                    <measurement group_id="O2" value="3151.2" spread="1107.18"/>
                    <measurement group_id="O3" value="2244.8" spread="572.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3549.7" spread="1238.03"/>
                    <measurement group_id="O2" value="3361.9" spread="1152.04"/>
                    <measurement group_id="O3" value="2250.8" spread="555.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3939.7" spread="2499.63"/>
                    <measurement group_id="O2" value="3234.7" spread="1207.58"/>
                    <measurement group_id="O3" value="2326.4" spread="494.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3307.0" spread="1387.97"/>
                    <measurement group_id="O2" value="3451.5" spread="1075.47"/>
                    <measurement group_id="O3" value="2265.7" spread="412.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: t1/2 for TFV</title>
        <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; at Weeks 4, 8, 16, and 24</time_frame>
        <population>Participants in the TFV PK Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O3">
            <title>ATR + Iohexol</title>
            <description>ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: t1/2 for TFV</title>
          <population>Participants in the TFV PK Analysis Set with available data were analyzed.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.73" lower_limit="12.49" upper_limit="18.90"/>
                    <measurement group_id="O2" value="14.10" lower_limit="13.28" upper_limit="16.81"/>
                    <measurement group_id="O3" value="20.65" lower_limit="15.30" upper_limit="26.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.40" lower_limit="12.07" upper_limit="16.83"/>
                    <measurement group_id="O2" value="15.82" lower_limit="11.94" upper_limit="19.53"/>
                    <measurement group_id="O3" value="18.81" lower_limit="13.08" upper_limit="25.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.41" lower_limit="13.11" upper_limit="19.87"/>
                    <measurement group_id="O2" value="14.72" lower_limit="12.76" upper_limit="16.73"/>
                    <measurement group_id="O3" value="22.78" lower_limit="16.88" upper_limit="32.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.99" lower_limit="11.91" upper_limit="18.52"/>
                    <measurement group_id="O2" value="16.17" lower_limit="13.18" upper_limit="21.37"/>
                    <measurement group_id="O3" value="21.54" lower_limit="19.39" upper_limit="27.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: AUCinf for Iohexol</title>
        <description>AUC inf is defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).</description>
        <time_frame>Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post &quot;time zero&quot; on Day 1 and Weeks 4, 8, 16, and 24</time_frame>
        <population>Participants in the iohexol PK Analysis Set (all treated participants who have respective, evaluable PK profiles of iohexol) with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O3">
            <title>ATR + Iohexol</title>
            <description>ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O4">
            <title>ABC/3TC + ATV/r + Iohexol</title>
            <description>ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: AUCinf for Iohexol</title>
          <description>AUC inf is defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).</description>
          <population>Participants in the iohexol PK Analysis Set (all treated participants who have respective, evaluable PK profiles of iohexol) with available data were analyzed.</population>
          <units>h*µg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="16"/>
                    <count group_id="O4" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="511.2" spread="172.71"/>
                    <measurement group_id="O2" value="486.8" spread="108.28"/>
                    <measurement group_id="O3" value="706.9" spread="647.25"/>
                    <measurement group_id="O4" value="695.2" spread="523.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="521.8" spread="121.67"/>
                    <measurement group_id="O2" value="496.2" spread="153.05"/>
                    <measurement group_id="O3" value="512.6" spread="163.89"/>
                    <measurement group_id="O4" value="720.5" spread="657.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="517.8" spread="170.24"/>
                    <measurement group_id="O2" value="574.8" spread="382.63"/>
                    <measurement group_id="O3" value="510.6" spread="136.40"/>
                    <measurement group_id="O4" value="667.0" spread="559.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="494.3" spread="113.60"/>
                    <measurement group_id="O2" value="509.5" spread="156.98"/>
                    <measurement group_id="O3" value="504.8" spread="95.07"/>
                    <measurement group_id="O4" value="725.9" spread="843.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="545.8" spread="127.34"/>
                    <measurement group_id="O2" value="561.2" spread="214.26"/>
                    <measurement group_id="O3" value="507.1" spread="113.45"/>
                    <measurement group_id="O4" value="606.5" spread="321.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HIV-1 RNA &lt; 50 Copies/mL Week 24 as Determined by Snapshot Algorithm</title>
        <time_frame>Week 24</time_frame>
        <population>Full Analysis Set (FAS): all participants who (1) are randomized into the study and (2) have received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O3">
            <title>ATR + Iohexol</title>
            <description>ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O4">
            <title>ABC/3TC + ATV/r + Iohexol</title>
            <description>ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HIV-1 RNA &lt; 50 Copies/mL Week 24 as Determined by Snapshot Algorithm</title>
          <population>Full Analysis Set (FAS): all participants who (1) are randomized into the study and (2) have received at least one dose of study drug.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.2"/>
                    <measurement group_id="O2" value="81.3"/>
                    <measurement group_id="O3" value="81.3"/>
                    <measurement group_id="O4" value="88.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 24</title>
        <time_frame>Baseline; Week 24</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O3">
            <title>ATR + Iohexol</title>
            <description>ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O4">
            <title>ABC/3TC + ATV/r + Iohexol</title>
            <description>ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 24</title>
          <population>Full Analysis Set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="139.63" spread="142.196"/>
                    <measurement group_id="O2" value="217.60" spread="195.375"/>
                    <measurement group_id="O3" value="204.33" spread="194.653"/>
                    <measurement group_id="O4" value="237.29" spread="201.222"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Experiencing Adverse Events (AEs)</title>
        <description>Incidences of adverse events and laboratory abnormalities will be summarized.</description>
        <time_frame>Up to the last dose date plus 30 days (Up to 24 weeks plus 30 days)</time_frame>
        <population>Safety Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O3">
            <title>ATR + Iohexol</title>
            <description>ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O4">
            <title>ABC/3TC + ATV/r + Iohexol</title>
            <description>ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Experiencing Adverse Events (AEs)</title>
          <description>Incidences of adverse events and laboratory abnormalities will be summarized.</description>
          <population>Safety Analysis Set</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Treatment-Emergent Adverse Events (TEAE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.6"/>
                    <measurement group_id="O2" value="87.5"/>
                    <measurement group_id="O3" value="87.5"/>
                    <measurement group_id="O4" value="88.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Grade 3 or 4 Treatment-Emergent Adverse Event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9"/>
                    <measurement group_id="O2" value="12.5"/>
                    <measurement group_id="O3" value="12.5"/>
                    <measurement group_id="O4" value="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Treatment-Emergent Study-Drug-Related AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8"/>
                    <measurement group_id="O2" value="50.0"/>
                    <measurement group_id="O3" value="68.8"/>
                    <measurement group_id="O4" value="23.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any TEAE Leading to Study Drug Discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9"/>
                    <measurement group_id="O2" value="6.3"/>
                    <measurement group_id="O3" value="6.3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory Abnormalities</title>
        <description>Graded laboratory abnormalities were defined as values that increased at least one toxicity grade from predose at any postdose up to the last dose date of study drug plus 30 days. The most severe graded abnormality from all tests was counted for each participant.</description>
        <time_frame>Up to the last dose date plus 30 days (Up to 24 weeks plus 30 days)</time_frame>
        <population>Safety Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>STB + Iohexol</title>
            <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O2">
            <title>TVD + ATV/r + Iohexol</title>
            <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O3">
            <title>ATR + Iohexol</title>
            <description>ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
          <group group_id="O4">
            <title>ABC/3TC + ATV/r + Iohexol</title>
            <description>ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory Abnormalities</title>
          <description>Graded laboratory abnormalities were defined as values that increased at least one toxicity grade from predose at any postdose up to the last dose date of study drug plus 30 days. The most severe graded abnormality from all tests was counted for each participant.</description>
          <population>Safety Analysis Set</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Grade 3 or 4 TE Laboratory Abnormality</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9"/>
                    <measurement group_id="O2" value="25.0"/>
                    <measurement group_id="O3" value="12.5"/>
                    <measurement group_id="O4" value="52.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 or 4 Neutrophils</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6.3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 or 4 Amylase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="6.3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 or 4 AST</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6.3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 or 4 CK</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9"/>
                    <measurement group_id="O2" value="18.8"/>
                    <measurement group_id="O3" value="6.3"/>
                    <measurement group_id="O4" value="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 or 4 Total Bilirubin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="12.5"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="52.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 or 4 Urine RBC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="7.7"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days)</time_frame>
      <desc>Safety Analysis Set</desc>
      <group_list>
        <group group_id="E1">
          <title>STB + Iohexol</title>
          <description>STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
        </group>
        <group group_id="E2">
          <title>TVD + ATV/r + Iohexol</title>
          <description>TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24</description>
        </group>
        <group group_id="E3">
          <title>ATR + Iohexol</title>
          <description>ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
        </group>
        <group group_id="E4">
          <title>ABC/3TC + ATV/r + Iohexol</title>
          <description>ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>LIVER INJURY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>ANAL ABSCESS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>PNEUMONIA BACTERIAL</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>OVERDOSE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>UPPER LIMB FRACTURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>INTENTIONAL SELF-INJURY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE KIDNEY INJURY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>ANAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>EYE PAIN</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>OCULAR ICTERUS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ANAL FISSURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>DIARRHOEA HAEMORRHAGIC</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>DRY MOUTH</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>DYSPEPSIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>FLATULENCE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>HAEMORRHOIDS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>TOOTHACHE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>ASTHENIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>INFLUENZA LIKE ILLNESS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>PAIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>JAUNDICE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>SEASONAL ALLERGY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>ACUTE HEPATITIS C</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>ANAL CHLAMYDIA INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>CYSTITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>EAR INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>EYE ABSCESS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>EYELID BOIL</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>FUNGAL SKIN INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>FURUNCLE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>GASTROENTERITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>GONORRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>LARYNGITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>NASOPHARYNGITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>ONYCHOMYCOSIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>OTITIS EXTERNA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>SYPHILIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>TINEA CRURIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>TINEA PEDIS</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>TINEA VERSICOLOUR</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>PROCEDURAL PAIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>TRAUMATIC HAEMATOMA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>BLOOD CREATINE PHOSPHOKINASE INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>LIVER FUNCTION TEST ABNORMAL</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>INCREASED APPETITE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>NECK PAIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>ANOGENITAL WARTS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>HEAD DISCOMFORT</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>HYPOAESTHESIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>LETHARGY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>NERVOUS SYSTEM DISORDER</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>ABNORMAL BEHAVIOUR</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>ABNORMAL DREAMS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>DEPRESSED MOOD</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>DISORIENTATION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>INDIFFERENCE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>INSOMNIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>NIGHTMARE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>SLEEP DISORDER</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>TERMINAL INSOMNIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>CATARRH</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>COUGH</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>NASAL CONGESTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>OROPHARYNGEAL PAIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>DERMATITIS ALLERGIC</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>ERYTHEMA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>INGROWING NAIL</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>PRURITUS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>RASH</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>RASH ERYTHEMATOUS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HAEMATOMA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>HOT FLUSH</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>HYPOTENSION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>SPIDER VEIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:&#xD;
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or&#xD;
The study has been completed at all study sites for at least 2 years</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>There were no limitations affecting the analysis or results.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Clinical Trial Disclosures</name_or_title>
      <organization>Gilead Sciences</organization>
      <email>ClinicalTrialDisclosures@gilead.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02246998
org study id: GS-US-236-0140
secondary id: 2014-002095-93
nct id: NCT02246998
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The primary objective of this study is to assess glomerular function before and during
      administration of stribild (STB; elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil
      fumarate (E/C/F/TDF)) or a regimen containing TDF without cobicistat (COBI) as ritonavir
      (RTV)-boosted atazanavir (ATV/r) plus truvada (TVD; FTC/TDF) or atripla (ATR;
      efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF)) compared to a regimen
      containing neither TDF nor COBI as ATV/r plus abacavir/lamivudine (ABC/3TC) via determination
      of actual glomerular filtration rate (aGFR) using iohexol (a probe GFR marker) plasma
      clearance and estimated (calculated) glomerular filtration rate (eGFR).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Actual Glomerular Filtration Rate (aGFR) Using Iohexol Plasma Clearance (CLiohexol) at Week 24
time frame: Week 24
measure: Estimated GFR (eGFR) Calculated by Cockcroft-Gault Formula at Week 24
time frame: Week 24
description: GFR is a measure of the rate at which blood is filtered by the kidney. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. eGFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL
measure: Estimated GFR Calculated by Modification of Diet in Renal Disease (MDRD) Formula at Week 24
time frame: Week 24
description: MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. eGFR (mL/min/1.73 m^2) = 186 * (Scr)^-1.154 * (Age)^(-0.203) * (0.742 if female) * (1.212 if black). Scr = serum creatinine in mg/dL
measure: Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)
time frame: Up to 24 weeks plus 30 days
measure: Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)
time frame: Up to 24 weeks plus 30 days
measure: Percentage Change From Baseline in Urine Albumin to Creatinine Ratio (mg/g) at Week 24
time frame: Baseline; Week 24
measure: Percentage Change From Baseline in Urine Protein to Creatinine Ratio (mg/g) at Week 24
time frame: Baseline; Week 24
measure: Percentage Change From Baseline in Urine β2-microglobulin to Creatinine Ratio (µg/g) at Week 24
time frame: Baseline; Week 24
measure: Percentage Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio (µg/g) at Week 24
time frame: Baseline; Week 24
measure: Pharmacokinetic (PK) Parameter: Cmax for COBI
time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
description: Cmax is defined as the maximum observed concentration of drug in plasma.
measure: PK Parameter: Tmax for COBI
time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
description: Tmax is defined as the time of Cmax.
measure: PK Parameter: Clast for COBI
time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
description: Clast is defined as the last observable concentration of drug.
measure: PK Parameter: Tlast for COBI
time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
description: Tlast is defined as the time of Clast.
Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.
measure: PK Parameter: Ctau for COBI
time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
description: Ctau is defined as the observed drug concentration at the end of the dosing interval.
measure: PK Parameter: λz for COBI
time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
description: λz is defined as the terminal elimination rate constant.
measure: PK Parameter: AUCtau for COBI
time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
description: AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).
measure: PK Parameter: t1/2 for COBI
time frame: Predose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
description: t1/2 is defined as the estimate of the terminal elimination half-life of the drug.
measure: PK Parameter: Cmax for RTV
time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
measure: PK Parameter: Tmax for RTV
time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
measure: PK Parameter: Clast for RTV
time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
measure: PK Parameter: Tlast for RTV
time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
description: Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.
measure: PK Parameter: Ctau for RTV
time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
measure: PK Parameter: AUCtau for RTV
time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
measure: PK Parameter: λz for RTV
time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
measure: PK Parameter: t1/2 for RTV
time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
measure: PK Parameter: Cmax for TFV
time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
measure: PK Parameter: Tmax for TFV
time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
measure: PK Parameter: Clast for TFV
time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
measure: PK Parameter: Tlast for TFV
time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
description: Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.
measure: PK Parameter: Ctau for TFV
time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
measure: PK Parameter: λz for TFV
time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
measure: PK Parameter: AUCtau for TFV
time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
measure: PK Parameter: t1/2 for TFV
time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
measure: PK Parameter: AUCinf for Iohexol
time frame: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" on Day 1 and Weeks 4, 8, 16, and 24
description: AUC inf is defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL Week 24 as Determined by Snapshot Algorithm
time frame: Week 24
measure: Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 24
time frame: Baseline; Week 24
measure: Percentage of Participants Experiencing Adverse Events (AEs)
time frame: Up to the last dose date plus 30 days (Up to 24 weeks plus 30 days)
description: Incidences of adverse events and laboratory abnormalities will be summarized.
measure: Percentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory Abnormalities
time frame: Up to the last dose date plus 30 days (Up to 24 weeks plus 30 days)
description: Graded laboratory abnormalities were defined as values that increased at least one toxicity grade from predose at any postdose up to the last dose date of study drug plus 30 days. The most severe graded abnormality from all tests was counted for each participant.
arm group label: STB+iohexol
arm group type: Experimental
description: Participants will receive STB+iohexol for 24 weeks.
arm group label: RTV+ATV+TVD+iohexol
arm group type: Experimental
description: Participants will receive RTV+ATV+TVD+iohexol for 24 weeks.
arm group label: ATR+iohexol
arm group type: Experimental
description: Participants will receive ATR+iohexol for 24 weeks.
arm group label: RTV+ATV+ABC/3TC+iohexol
arm group type: Experimental
description: Participants will receive RTV+ATV+ABC/3TC+iohexol for 24 weeks.
intervention type: Drug
intervention name: STB
description: 150/150/200/300 mg fixed dose combination (FDC) tablet administered orally once daily with food
arm group label: STB+iohexol
other name: Stribild®
intervention type: Drug
intervention name: TVD
description: 200/300 mg FDC tablet administered orally once daily with food
arm group label: RTV+ATV+TVD+iohexol
other name: Truvada®
intervention type: Drug
intervention name: ATR
description: 600/200/300 mg FDC tablet administered orally once daily on an empty stomach at bedtime
arm group label: ATR+iohexol
other name: Atripla®
intervention type: Drug
intervention name: RTV
description: 100 mg tablet administered orally once daily with food
arm group label: RTV+ATV+ABC/3TC+iohexol
arm group label: RTV+ATV+TVD+iohexol
other name: Norvir®
intervention type: Drug
intervention name: ATV
description: 300 mg capsule administered orally once daily with food
arm group label: RTV+ATV+ABC/3TC+iohexol
arm group label: RTV+ATV+TVD+iohexol
other name: Reyataz®
intervention type: Drug
intervention name: ABC/3TC
description: 600/300 mg FDC tablet administered orally once daily with food
arm group label: RTV+ATV+ABC/3TC+iohexol
other name: Kivexa®
intervention type: Drug
intervention name: Iohexol
description: 1500 mg solution administered intravenously at baseline, and at Weeks 4, 8, 16, and 24
arm group label: ATR+iohexol
arm group label: RTV+ATV+ABC/3TC+iohexol
arm group label: RTV+ATV+TVD+iohexol
arm group label: STB+iohexol
other name: Omnipaque™
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Gilead Study Director
role: Study Director
affiliation: Gilead Sciences
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country: Belgium
country: France
country: Ireland
country: Spain
country: United Kingdom
responsible party type: Sponsor
mesh term: Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: There were no limitations affecting the analysis or results.
point of contact: 