<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/NCT04442737</url>
  </required_header>
  <id_info>
    <org_study_id>CR108757</org_study_id>
    <secondary_id>TMC114FD2HTX4004</secondary_id>
    <nct_id>NCT04442737</nct_id>
  </id_info>
  <brief_title>A Study of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Evaluated as a Fixed Dose Combination Regimen in Participants Switching From an Integrase Inhibitor Who Have Experienced Rapid Weight Gain</brief_title>
  <acronym>DEFINE</acronym>
  <official_title>A Phase 4, Randomized, Active-Controlled, Open-label Study to Evaluate the Safety and Tolerability of Switching to Once-Daily Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-dose Combination (FDC) Regimen in Virologically-suppressed Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Experiencing Rapid Weight Gain With an INI + TAF/FTC ARV Regimen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Scientific Affairs, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Scientific Affairs, LLC</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the percent change in body weight when switching to&#xD;
      darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination&#xD;
      (FDC) (Immediate Switch Arm) compared to continuing the current integrase (INI) + tenofovir&#xD;
      alafenamide/emtricitabine (TAF/FTC) antiretroviral (ARV) regimen (Delayed Switch Arm) in&#xD;
      virologically-suppressed human immunodeficiency virus (HIV)-1 infected participants who have&#xD;
      experienced rapid and significant body weight gain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">August 24, 2023</completion_date>
  <primary_completion_date type="Actual">August 7, 2023</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>Percent Change from Baseline in Body Weight at Week 24</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>Percent change from baseline in body weight at Week 24 will be reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Absolute Body Weight at Weeks 24 and 48</measure>
    <time_frame>Baseline, Weeks 24 and 48</time_frame>
    <description>Change from baseline in absolute body weight at Weeks 24 and 48 will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Percent Change in Body Weight Greater Than (&gt;) 3 Percent (%) at Weeks 24 and 48</measure>
    <time_frame>Weeks 24 and 48</time_frame>
    <description>Percentage of participants with % change in body weight &gt;3% at Weeks 24 and 48 will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Percent Change in Body Weight &gt;5% at Weeks 24 and 48</measure>
    <time_frame>Weeks 24 and 48</time_frame>
    <description>Percentage of participants with % change in body weight &gt;5% at Weeks 24 and 48 will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Body Mass Index (BMI) at Weeks 24 and 48</measure>
    <time_frame>Baseline, Weeks 24 and 48</time_frame>
    <description>Change from baseline in BMI at Weeks 24 and 48 will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48</measure>
    <time_frame>Baseline, Weeks 24 and 48</time_frame>
    <description>Change from baseline in body composition (absolute mass of fat, lean body mass and total mass) as measured by DEXA scan at Weeks 24 and 48 will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Waist Circumference at Weeks 24 and 48</measure>
    <time_frame>Baseline, Weeks 24 and 48</time_frame>
    <description>Change from baseline in waist circumference at Weeks 24 and 48 will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 24 and 48</measure>
    <time_frame>Baseline, Weeks 24 and 48</time_frame>
    <description>Change from baseline in SBP and DBP from Baseline at Weeks 24 and 48 will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Fasting Lipids at Weeks 24 and 48</measure>
    <time_frame>Baseline, Weeks 24 and 48</time_frame>
    <description>Change from baseline in fasting lipids at Weeks 24 and 48 will be reported. Fasting plasma lipids are measured to determine triglyceride or cholesterol concentrations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Fasting Glucose at Weeks 24 and 48</measure>
    <time_frame>Baseline, Weeks 24 and 48</time_frame>
    <description>Change from baseline in fasting glucose at Weeks 24 and 48 will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Weeks 24 and 48</measure>
    <time_frame>Baseline, Weeks 24 and 48</time_frame>
    <description>Change from baseline in HOMA-IR at Weeks 24 and 48 will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Hemoglobin A1c (HbA1c) at Weeks 24 and 48</measure>
    <time_frame>Baseline, Weeks 24 and 48</time_frame>
    <description>Change from baseline in HbA1c at Weeks 24 and 48 will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Leptin at Weeks 24 and 48</measure>
    <time_frame>Baseline, Weeks 24 and 48</time_frame>
    <description>Change from baseline in leptin at Weeks 24 and 48 will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Adiponectin at Weeks 24 and 48</measure>
    <time_frame>Baseline, Weeks 24 and 48</time_frame>
    <description>Change from baseline in adiponectin at Weeks 24 and 48 will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in the Percentage of Participants with Advanced Fibrosis as Assessed by Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score at Weeks 24 and 48</measure>
    <time_frame>Baseline, Weeks 24 and 48</time_frame>
    <description>Change from baseline in the percentage of participants with advanced fibrosis according to the NAFLD fibrosis score at Weeks 24 and 48 will be reported. In participants with NAFLD Score less than (&lt; ) -1.455, advanced liver fibrosis can be excluded with high accuracy and NAFLD Score greater than (&gt;) 0.675, the presence of advanced liver fibrosis can be diagnosed with high accuracy. Scores between -1.455 and 0.675 are considered &quot;indeterminate&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in the Percentage of Participants at High Risk of Nonalcoholic Fatty Liver Disease (NASH) According to the Hypertension, Age, Insulin, Resistance (HAIR) Score at Weeks 24 and 48</measure>
    <time_frame>Baseline, Weeks 24 and 48</time_frame>
    <description>Change from baseline in the percentage of participants at high risk of NASH according to the HAIR score at Weeks 24 and 48 will be reported. HAIR score ranges from 0-3 which is calculated by adding Hypertension = 1, ALT &gt;40 IU=1, and insulin resistance (IR) index &gt;5.0 = 1. A score of greater than or equal to (&gt;=) 2 is high risk for NASH.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with a Dose-reduction or Complete Withdrawal of Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents</measure>
    <time_frame>Baseline up to Weeks 24 and 48</time_frame>
    <description>Percentage of participants with a dose-reduction or complete withdrawal of anti-hypertensive, anti-hyperglycemic, or lipid lowering agents from baseline to Weeks 24 and 48 will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Initiating an Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agent</measure>
    <time_frame>Baseline up to Weeks 24 and 48</time_frame>
    <description>Percentage of participants initiating an anti-hypertensive, anti-hyperglycemic, or lipid lowering agent from baseline to Weeks 24 and 48 will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with any Grade Adverse Events (AEs)</measure>
    <time_frame>Up to 24 and 48 weeks</time_frame>
    <description>Percentage of participants with any Grade AEs (related and not related) will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Grade 3 and Grade 4 AEs</measure>
    <time_frame>Up to 24 and 48 weeks</time_frame>
    <description>Percentage of participants with Grade 3 and Grade 4 AEs (related and not related) will be reported where Grade 3: Severe and Grade 4: Potentially life-threatening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants who Discontinued due to AEs</measure>
    <time_frame>Up to 24 and 48 weeks</time_frame>
    <description>Percentage of participants who discontinued due to AEs will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to 24 and 48 weeks</time_frame>
    <description>Percentage of participants with SAEs (related and not related) through Week 24 and Week 48 will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Biochemistry Tests</measure>
    <time_frame>Baseline, Weeks 24 and 48</time_frame>
    <description>Change from baseline in biochemistry tests (such as sodium, potassium, chloride, bicarbonate, blood urea nitrogen, serum creatinine, glucose, aspartate aminotransferase, alanine aminotransferase, insulin, bilirubin [total, direct, indirect], alkaline phosphatase, calcium, calcium corrected for albumin, phosphate, albumin, total protein) through Weeks 24 and 48 will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Hematology Tests</measure>
    <time_frame>Baseline, Weeks 24 and 48</time_frame>
    <description>Change from baseline in hematology tests (hematocrit, hemoglobin, platelet count, red blood cell count, absolute neutrophil count, white blood cell count) through Weeks 24 and 48 will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Urinalysis Tests</measure>
    <time_frame>Baseline, Weeks 24 and 48</time_frame>
    <description>Change from baseline in urinalysis tests (specific gravity, pH, glucose, protein, blood ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase) through Weeks 24 and 48 will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Urine Chemistry Tests</measure>
    <time_frame>Baseline, Weeks 24 and 48</time_frame>
    <description>If applicable, change from baseline in urine chemistry tests (urine creatinine, urine sodium, urine phosphate, urine glucose, urine albumin, urine protein, serum creatinine) through Weeks 24 and 48 will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Grade 3 and Grade 4 Laboratory Abnormalities</measure>
    <time_frame>Up to 24 and 48 weeks</time_frame>
    <description>Percentage of participants with Grade 3 and Grade 4 laboratory abnormalities will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Confirmed Virologic Rebound</measure>
    <time_frame>Up to Weeks 24 and 48</time_frame>
    <description>Percentage of participants with confirmed virologic rebound through Weeks 24 and 48 will be reported. Virologic rebound is defined as the 2 consecutive human immunodeficiency virus type-1 ribonucleic acid (HIV-1 RNA) values greater than or equal to (&gt;=) 200 copies/milliliter (mL) at a scheduled or unscheduled visit after maintaining HIV-1 RNA less than (&lt;) 50 copies/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Virologic Response (HIV-1 RNA&lt;50 copies/mL) at Weeks 24 and 48</measure>
    <time_frame>Weeks 24 and 48</time_frame>
    <description>Percentage of participants with virologic response (HIV-1 RNA &lt;50 copies/mL), at Weeks 24 and 48 according to the Food Drug Administration (FDA) snapshot algorithm will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Virologic Failure (HIV-1 RNA ≥50 copies/mL) at Weeks 24 and 48</measure>
    <time_frame>Weeks 24 and 48</time_frame>
    <description>Percentage participants with virologic failure (HIV-1 RNA &gt;=50 copies/mL) at Weeks 24 and 48 according to the FDA snapshot algorithm will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Having Virologic Response (HIV-1 RNA&lt;200 copies/mL) at Weeks 24 and 48</measure>
    <time_frame>Weeks 24 and 48</time_frame>
    <description>Percentage participants with virologic response (HIV-1 RNA &lt; 200 copies/mL) at Weeks 24 and 48 according to the FDA snapshot algorithm will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Having Virologic Failure (HIV-1 RNA ≥200 copies/mL) at Weeks 24 and 48</measure>
    <time_frame>Weeks 24 and 48</time_frame>
    <description>Percentage participants having virologic failure, that is HIV-1 RNA &gt;= 200 copies/mL, at Weeks 24 and 48 according to the FDA snapshot algorithm will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Cluster of Differentiation-4 (CD4+) Cell Count at Weeks 24 and 48</measure>
    <time_frame>Baseline, Weeks 24 and 48</time_frame>
    <description>Change from baseline in CD4+ cell count at Weeks 24 and 48 will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Pre-baseline Protease (PR), Reverse Transcriptase (RT), and Integrase (INI) Resistance-Associated Mutation (RAMs)</measure>
    <time_frame>Baseline (Day 1)</time_frame>
    <description>Percentage of participants with pre-baseline PR, RT, and INI RAMs based on historical genotypes will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participant with Newly Identified Post-Baseline RAMS and Phenotypic Resistance Compared to Pre-baseline Resistance Tests</measure>
    <time_frame>Up to Week 48</time_frame>
    <description>Percentage of participant with newly identified post-baseline RAMs and phenotypic resistance compared to pre-baseline resistance tests when available, upon meeting confirmed virologic rebound through Week 48.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Genotypic and Phenotypic Antiretroviral (ARV) Resistance for Meeting HIV-1 RNA Rebound Criteria up to Weeks 24 and 48</measure>
    <time_frame>Up to Weeks 24 and 48</time_frame>
    <description>Percentage of participants with genotypic and phenotypic ARV resistance who are meeting HIV-1 RNA rebound criteria through Weeks 24 and 48 will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in the Percentage of Participants who Have Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across all Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48</measure>
    <time_frame>Baseline, Weeks 24 and 48</time_frame>
    <description>Change from baseline in the percentage of participants who have bothersome symptoms (scores of 1, 2, 3 or 4) across all items of the HIV-SI at Weeks 24 and 48 will be reported. The HIV-SI assesses 20 items which are evaluated on a scale of 0-4 where 0= I do not have this symptom to 4=It bothers me a lot'. Minimum HIV-SI score is 0 and maximum HIV-SI score is 80.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in the Percentage of Participants who Have Any Symptoms (scores of 1, 2, 3 or 4) Across all Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48</measure>
    <time_frame>Baseline, Weeks 24 and 48</time_frame>
    <description>Change from baseline in the percentage of participants who have any symptoms (scores of 1, 2, 3 or 4) across all items of the HIV-SI at Weeks 24 and 48 will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association Between Treatment Arm and Each Bothersome Symptom of the HIV-SI Adjusting for Baseline Variables at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>Association between treatment arm and each bothersome symptom of the HIV-SI adjusting for Baseline variables at Week 24 will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change (PGIC) Scale</measure>
    <time_frame>Weeks 24 and 48</time_frame>
    <description>The PGIC is a global index that is used to rate the overall status of the participant related to the participant's overall condition. It is rated by the participant and is based on the single question, &quot;compared to before starting the study or compared to the Week 24 and Week 48 visits, my overall status is,&quot; where response choices include 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence Rate to Treatment at Weeks 4, 12 and 24</measure>
    <time_frame>Weeks 4, 12, 24, 36 and 48</time_frame>
    <description>Adherence rate to treatment will be assessed by participant self-report using 4-day recall at Weeks 4, 12, 24, 36 and 48.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">103</enrollment>
  <condition>HIV-1</condition>
  <arm_group>
    <arm_group_label>D/C/F/TAF FDC Arm (Immediate Switch)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be immediately switched to a regimen of darunavir 800 milligram (mg)/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg (D/C/F/TAF) fixed-dose combination (FDC) once daily for 48 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>INI + TAF/FTC Arm (Delayed Switch)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will continue to receive current baseline integrase (INI)-based regimen plus Tenofovir Alafenamide/Emtricitabine (TAF/FTC) antiretroviral (ARV) regimen for 24 weeks. After 24 weeks participants will switch to a regimen of D/C/F/TAF FDC once daily for an additional 24 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>D/C/F/TAF FDC</intervention_name>
    <description>A FDC tablet containing darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, tenofovir alafenamide 10 mg will be administered once daily.</description>
    <arm_group_label>D/C/F/TAF FDC Arm (Immediate Switch)</arm_group_label>
    <arm_group_label>INI + TAF/FTC Arm (Delayed Switch)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAF/FTC FDC</intervention_name>
    <description>TAF/FTC ARV regimen will be administered once daily.</description>
    <arm_group_label>INI + TAF/FTC Arm (Delayed Switch)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>INI Based Regimen</intervention_name>
    <description>The integrase (INI) inhibitors (for example, bictegravir, dolutegravir, elvitegravir/cobicistat, and raltegravir) will be administered in combination with TAF/FTC, as appropriate. Regimen may consist of a single tablet regimen or a combination of two separate pills.</description>
    <arm_group_label>INI + TAF/FTC Arm (Delayed Switch)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index (BMI) of greater than or equal to (&gt;=) 18 kilogram per meter square&#xD;
             (kg/m^2) at time of starting an integrase (INI)-based regimen plus Tenofovir&#xD;
             Alafenamide/Emtricitabine (TAF/FTC) antiretroviral (ARV) regimen&#xD;
&#xD;
          -  Documented human immunodeficiency virus (HIV)-1 infection&#xD;
&#xD;
          -  Currently being treated with a stable ARV regimen consisting of an INI combined with&#xD;
             TAF/FTC for &gt;=6 consecutive months preceding the screening visit and experienced a&#xD;
             &gt;=10 percent (%) increase in body weight within a 36-month time period prior to&#xD;
             screening and while on the current INI + TAF/FTC ARV regimen&#xD;
&#xD;
          -  Documented evidence of being virologically suppressed while on the current stable&#xD;
             INI+TAF/FTC ARV regimen prior to screening&#xD;
&#xD;
          -  At least one plasma HIV-1 RNA measurement less than (&lt;) 50 copies/milliliter (mL)&#xD;
             occurring between 12 and 2 months prior to the screening visit while on the stable&#xD;
             INI+ TAF/FTC ARV regimen and have HIV-1 RNA &lt;50 copies/ mL at the screening visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known history of malignancy within the past 5 years or ongoing malignancy other than&#xD;
             cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous&#xD;
             squamous carcinoma&#xD;
&#xD;
          -  Known allergies, hypersensitivity, or intolerance to D/C/F/TAF fixed-dose combination&#xD;
             (FDC) tablet or its excipients&#xD;
&#xD;
          -  Active hepatitis B (HBV) or hepatitis C virus (HCV) infection&#xD;
&#xD;
          -  Uncontrolled diabetes that will require treatment with insulin during the study period&#xD;
&#xD;
          -  Evidence of Child Pugh Class C based on clinical laboratory testing and clinical&#xD;
             evaluation&#xD;
&#xD;
          -  History of failure on darunavir (DRV) treatment or known documented history of &gt;=1 DRV&#xD;
             resistance-associated mutations (RAM)&#xD;
&#xD;
          -  Screening hepatic transaminases &gt;5x the upper limit of the normal range&#xD;
&#xD;
          -  Screening creatinine based estimated glomerular filtration rate (eGFRcr) &lt;30 ml/min&#xD;
             according to the Cockcroft-Gault formula for creatinine clearance&#xD;
&#xD;
          -  Participants initiating or discontinuing concomitant medications associated with&#xD;
             significant changes in weight within the last 90 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Scientific Affairs, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Scientific Affairs, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35222</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Office of Franco Felizarta, MD</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AIDS Health Foundation-Westside HCC</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Long Beach Education &amp; Research Consultants</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midway Immunology and Research Center</name>
      <address>
        <city>Fort Pierce</city>
        <state>Florida</state>
        <zip>34982</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Triple O Research Institute</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta ID Group</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Georgia</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Corporation of Mercer University</name>
      <address>
        <city>Macon</city>
        <state>Georgia</state>
        <zip>31201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chatham County Health Department</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ruth M. Rothstein CORE Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Care South Clinic</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20852</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Research Initiative</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Be Well Medical Center, PC</name>
      <address>
        <city>Berkley</city>
        <state>Michigan</state>
        <zip>48072</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Nebraska</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Michaels Medical Center - Infectious Disease</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AIDS Healthcare Foundation-Research Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Hospital-New York</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Philadelphia Fight</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palmetto Health - USC</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AIDS Arms Incorporated Trinity Health and Wellness Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Texas Infectious Diseases Consultants</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Centers for Infectious Disease Associates</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Therapeutic Concepts - Donald R Watkins Foundation</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DCOL Center for Clinical Research</name>
      <address>
        <city>Longview</city>
        <state>Texas</state>
        <zip>75605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Infectious Disease Associates of Central Virginia</name>
      <address>
        <city>Lynchburg</city>
        <state>Virginia</state>
        <zip>24501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vivent Health</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>September 13, 2023</last_update_submitted>
  <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Gain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data sharing policy of the Janssen Pharmaceutical Companies of Johnson &amp; Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu</ipd_description>
    <ipd_url>https://www.janssen.com/clinical-trials/transparency</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04442737
org study id: CR108757
secondary id: TMC114FD2HTX4004
nct id: NCT04442737
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the percent change in body weight when switching to
      darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination
      (FDC) (Immediate Switch Arm) compared to continuing the current integrase (INI) + tenofovir
      alafenamide/emtricitabine (TAF/FTC) antiretroviral (ARV) regimen (Delayed Switch Arm) in
      virologically-suppressed human immunodeficiency virus (HIV)-1 infected participants who have
      experienced rapid and significant body weight gain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percent Change from Baseline in Body Weight at Week 24
time frame: Baseline and Week 24
description: Percent change from baseline in body weight at Week 24 will be reported.
measure: Change from Baseline in Absolute Body Weight at Weeks 24 and 48
time frame: Baseline, Weeks 24 and 48
description: Change from baseline in absolute body weight at Weeks 24 and 48 will be reported.
measure: Percentage of Participants with Percent Change in Body Weight Greater Than (>) 3 Percent (%) at Weeks 24 and 48
time frame: Weeks 24 and 48
description: Percentage of participants with % change in body weight >3% at Weeks 24 and 48 will be reported.
measure: Percentage of Participants with Percent Change in Body Weight >5% at Weeks 24 and 48
time frame: Weeks 24 and 48
description: Percentage of participants with % change in body weight >5% at Weeks 24 and 48 will be reported.
measure: Change from Baseline in Body Mass Index (BMI) at Weeks 24 and 48
time frame: Baseline, Weeks 24 and 48
description: Change from baseline in BMI at Weeks 24 and 48 will be reported.
measure: Change from Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
time frame: Baseline, Weeks 24 and 48
description: Change from baseline in body composition (absolute mass of fat, lean body mass and total mass) as measured by DEXA scan at Weeks 24 and 48 will be reported.
measure: Change from Baseline in Waist Circumference at Weeks 24 and 48
time frame: Baseline, Weeks 24 and 48
description: Change from baseline in waist circumference at Weeks 24 and 48 will be reported.
measure: Change from Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 24 and 48
time frame: Baseline, Weeks 24 and 48
description: Change from baseline in SBP and DBP from Baseline at Weeks 24 and 48 will be reported.
measure: Change from Baseline in Fasting Lipids at Weeks 24 and 48
time frame: Baseline, Weeks 24 and 48
description: Change from baseline in fasting lipids at Weeks 24 and 48 will be reported. Fasting plasma lipids are measured to determine triglyceride or cholesterol concentrations.
measure: Change from Baseline in Fasting Glucose at Weeks 24 and 48
time frame: Baseline, Weeks 24 and 48
description: Change from baseline in fasting glucose at Weeks 24 and 48 will be reported.
measure: Change from Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Weeks 24 and 48
time frame: Baseline, Weeks 24 and 48
description: Change from baseline in HOMA-IR at Weeks 24 and 48 will be reported.
measure: Change from Baseline in Hemoglobin A1c (HbA1c) at Weeks 24 and 48
time frame: Baseline, Weeks 24 and 48
description: Change from baseline in HbA1c at Weeks 24 and 48 will be reported.
measure: Change from Baseline in Leptin at Weeks 24 and 48
time frame: Baseline, Weeks 24 and 48
description: Change from baseline in leptin at Weeks 24 and 48 will be reported.
measure: Change from Baseline in Adiponectin at Weeks 24 and 48
time frame: Baseline, Weeks 24 and 48
description: Change from baseline in adiponectin at Weeks 24 and 48 will be reported.
measure: Change from Baseline in the Percentage of Participants with Advanced Fibrosis as Assessed by Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score at Weeks 24 and 48
time frame: Baseline, Weeks 24 and 48
description: Change from baseline in the percentage of participants with advanced fibrosis according to the NAFLD fibrosis score at Weeks 24 and 48 will be reported. In participants with NAFLD Score less than (< ) -1.455, advanced liver fibrosis can be excluded with high accuracy and NAFLD Score greater than (>) 0.675, the presence of advanced liver fibrosis can be diagnosed with high accuracy. Scores between -1.455 and 0.675 are considered "indeterminate".
measure: Change from Baseline in the Percentage of Participants at High Risk of Nonalcoholic Fatty Liver Disease (NASH) According to the Hypertension, Age, Insulin, Resistance (HAIR) Score at Weeks 24 and 48
time frame: Baseline, Weeks 24 and 48
description: Change from baseline in the percentage of participants at high risk of NASH according to the HAIR score at Weeks 24 and 48 will be reported. HAIR score ranges from 0-3 which is calculated by adding Hypertension = 1, ALT >40 IU=1, and insulin resistance (IR) index >5.0 = 1. A score of greater than or equal to (>=) 2 is high risk for NASH.
measure: Percentage of Participants with a Dose-reduction or Complete Withdrawal of Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents
time frame: Baseline up to Weeks 24 and 48
description: Percentage of participants with a dose-reduction or complete withdrawal of anti-hypertensive, anti-hyperglycemic, or lipid lowering agents from baseline to Weeks 24 and 48 will be reported.
measure: Percentage of Participants Initiating an Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agent
time frame: Baseline up to Weeks 24 and 48
description: Percentage of participants initiating an anti-hypertensive, anti-hyperglycemic, or lipid lowering agent from baseline to Weeks 24 and 48 will be reported.
measure: Percentage of Participants with any Grade Adverse Events (AEs)
time frame: Up to 24 and 48 weeks
description: Percentage of participants with any Grade AEs (related and not related) will be reported.
measure: Percentage of Participants with Grade 3 and Grade 4 AEs
time frame: Up to 24 and 48 weeks
description: Percentage of participants with Grade 3 and Grade 4 AEs (related and not related) will be reported where Grade 3: Severe and Grade 4: Potentially life-threatening.
measure: Percentage of Participants who Discontinued due to AEs
time frame: Up to 24 and 48 weeks
description: Percentage of participants who discontinued due to AEs will be reported.
measure: Percentage of Participants with Serious Adverse Events (SAEs)
time frame: Up to 24 and 48 weeks
description: Percentage of participants with SAEs (related and not related) through Week 24 and Week 48 will be reported.
measure: Change from Baseline in Biochemistry Tests
time frame: Baseline, Weeks 24 and 48
description: Change from baseline in biochemistry tests (such as sodium, potassium, chloride, bicarbonate, blood urea nitrogen, serum creatinine, glucose, aspartate aminotransferase, alanine aminotransferase, insulin, bilirubin [total, direct, indirect], alkaline phosphatase, calcium, calcium corrected for albumin, phosphate, albumin, total protein) through Weeks 24 and 48 will be reported.
measure: Change from Baseline in Hematology Tests
time frame: Baseline, Weeks 24 and 48
description: Change from baseline in hematology tests (hematocrit, hemoglobin, platelet count, red blood cell count, absolute neutrophil count, white blood cell count) through Weeks 24 and 48 will be reported.
measure: Change from Baseline in Urinalysis Tests
time frame: Baseline, Weeks 24 and 48
description: Change from baseline in urinalysis tests (specific gravity, pH, glucose, protein, blood ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase) through Weeks 24 and 48 will be reported.
measure: Change from Baseline in Urine Chemistry Tests
time frame: Baseline, Weeks 24 and 48
description: If applicable, change from baseline in urine chemistry tests (urine creatinine, urine sodium, urine phosphate, urine glucose, urine albumin, urine protein, serum creatinine) through Weeks 24 and 48 will be reported.
measure: Percentage of Participants with Grade 3 and Grade 4 Laboratory Abnormalities
time frame: Up to 24 and 48 weeks
description: Percentage of participants with Grade 3 and Grade 4 laboratory abnormalities will be reported.
measure: Percentage of Participants with Confirmed Virologic Rebound
time frame: Up to Weeks 24 and 48
description: Percentage of participants with confirmed virologic rebound through Weeks 24 and 48 will be reported. Virologic rebound is defined as the 2 consecutive human immunodeficiency virus type-1 ribonucleic acid (HIV-1 RNA) values greater than or equal to (>=) 200 copies/milliliter (mL) at a scheduled or unscheduled visit after maintaining HIV-1 RNA less than (<) 50 copies/mL.
measure: Percentage of Participants with Virologic Response (HIV-1 RNA<50 copies/mL) at Weeks 24 and 48
time frame: Weeks 24 and 48
description: Percentage of participants with virologic response (HIV-1 RNA <50 copies/mL), at Weeks 24 and 48 according to the Food Drug Administration (FDA) snapshot algorithm will be reported.
measure: Percentage of Participants with Virologic Failure (HIV-1 RNA ≥50 copies/mL) at Weeks 24 and 48
time frame: Weeks 24 and 48
description: Percentage participants with virologic failure (HIV-1 RNA >=50 copies/mL) at Weeks 24 and 48 according to the FDA snapshot algorithm will be reported.
measure: Percentage of Participants Having Virologic Response (HIV-1 RNA<200 copies/mL) at Weeks 24 and 48
time frame: Weeks 24 and 48
description: Percentage participants with virologic response (HIV-1 RNA < 200 copies/mL) at Weeks 24 and 48 according to the FDA snapshot algorithm will be reported.
measure: Percentage of Participants Having Virologic Failure (HIV-1 RNA ≥200 copies/mL) at Weeks 24 and 48
time frame: Weeks 24 and 48
description: Percentage participants having virologic failure, that is HIV-1 RNA >= 200 copies/mL, at Weeks 24 and 48 according to the FDA snapshot algorithm will be reported.
measure: Change from Baseline in Cluster of Differentiation-4 (CD4+) Cell Count at Weeks 24 and 48
time frame: Baseline, Weeks 24 and 48
description: Change from baseline in CD4+ cell count at Weeks 24 and 48 will be reported.
measure: Percentage of Participants with Pre-baseline Protease (PR), Reverse Transcriptase (RT), and Integrase (INI) Resistance-Associated Mutation (RAMs)
time frame: Baseline (Day 1)
description: Percentage of participants with pre-baseline PR, RT, and INI RAMs based on historical genotypes will be reported.
measure: Percentage of Participant with Newly Identified Post-Baseline RAMS and Phenotypic Resistance Compared to Pre-baseline Resistance Tests
time frame: Up to Week 48
description: Percentage of participant with newly identified post-baseline RAMs and phenotypic resistance compared to pre-baseline resistance tests when available, upon meeting confirmed virologic rebound through Week 48.
measure: Percentage of Participants with Genotypic and Phenotypic Antiretroviral (ARV) Resistance for Meeting HIV-1 RNA Rebound Criteria up to Weeks 24 and 48
time frame: Up to Weeks 24 and 48
description: Percentage of participants with genotypic and phenotypic ARV resistance who are meeting HIV-1 RNA rebound criteria through Weeks 24 and 48 will be reported.
measure: Change from Baseline in the Percentage of Participants who Have Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across all Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
time frame: Baseline, Weeks 24 and 48
description: Change from baseline in the percentage of participants who have bothersome symptoms (scores of 1, 2, 3 or 4) across all items of the HIV-SI at Weeks 24 and 48 will be reported. The HIV-SI assesses 20 items which are evaluated on a scale of 0-4 where 0= I do not have this symptom to 4=It bothers me a lot'. Minimum HIV-SI score is 0 and maximum HIV-SI score is 80.
measure: Change from Baseline in the Percentage of Participants who Have Any Symptoms (scores of 1, 2, 3 or 4) Across all Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
time frame: Baseline, Weeks 24 and 48
description: Change from baseline in the percentage of participants who have any symptoms (scores of 1, 2, 3 or 4) across all items of the HIV-SI at Weeks 24 and 48 will be reported.
measure: Association Between Treatment Arm and Each Bothersome Symptom of the HIV-SI Adjusting for Baseline Variables at Week 24
time frame: Week 24
description: Association between treatment arm and each bothersome symptom of the HIV-SI adjusting for Baseline variables at Week 24 will be reported.
measure: Patient Global Impression of Change (PGIC) Scale
time frame: Weeks 24 and 48
description: The PGIC is a global index that is used to rate the overall status of the participant related to the participant's overall condition. It is rated by the participant and is based on the single question, "compared to before starting the study or compared to the Week 24 and Week 48 visits, my overall status is," where response choices include 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse.
measure: Adherence Rate to Treatment at Weeks 4, 12 and 24
time frame: Weeks 4, 12, 24, 36 and 48
description: Adherence rate to treatment will be assessed by participant self-report using 4-day recall at Weeks 4, 12, 24, 36 and 48.
arm group label: D/C/F/TAF FDC Arm (Immediate Switch)
arm group type: Experimental
description: Participants will be immediately switched to a regimen of darunavir 800 milligram (mg)/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg (D/C/F/TAF) fixed-dose combination (FDC) once daily for 48 weeks.
arm group label: INI + TAF/FTC Arm (Delayed Switch)
arm group type: Active Comparator
description: Participants will continue to receive current baseline integrase (INI)-based regimen plus Tenofovir Alafenamide/Emtricitabine (TAF/FTC) antiretroviral (ARV) regimen for 24 weeks. After 24 weeks participants will switch to a regimen of D/C/F/TAF FDC once daily for an additional 24 weeks.
intervention type: Drug
intervention name: D/C/F/TAF FDC
description: A FDC tablet containing darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, tenofovir alafenamide 10 mg will be administered once daily.
arm group label: D/C/F/TAF FDC Arm (Immediate Switch)
arm group label: INI + TAF/FTC Arm (Delayed Switch)
intervention type: Drug
intervention name: TAF/FTC FDC
description: TAF/FTC ARV regimen will be administered once daily.
arm group label: INI + TAF/FTC Arm (Delayed Switch)
intervention type: Drug
intervention name: INI Based Regimen
description: The integrase (INI) inhibitors (for example, bictegravir, dolutegravir, elvitegravir/cobicistat, and raltegravir) will be administered in combination with TAF/FTC, as appropriate. Regimen may consist of a single tablet regimen or a combination of two separate pills.
arm group label: INI + TAF/FTC Arm (Delayed Switch)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Scientific Affairs, LLC Clinical Trial
role: Study Director
affiliation: Janssen Scientific Affairs, LLC
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country: United States
responsible party type: Sponsor
mesh term: Weight Gain
sharing ipd: Yes
ipd description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
ipd url: https://www.janssen.com/clinical-trials/transparency