<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/NCT02194998</url>
  </required_header>
  <id_info>
    <org_study_id>A5329</org_study_id>
    <secondary_id>11935</secondary_id>
    <nct_id>NCT02194998</nct_id>
  </id_info>
  <brief_title>Evaluating the Safety and Effectiveness of Interferon-Free Treatment of Hepatitis C Virus Infection in HIV-Coinfected Adults on Antiretroviral Therapy</brief_title>
  <acronym>C_ASCENT</acronym>
  <official_title>Interferon-Free Therapy for Chronic Hepatitis C Virus Genotype 1 Infection in Participants With HIV-1 Coinfection Receiving Concurrent Antiretroviral Therapy (C_ASCENT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institute of Allergy and Infectious Diseases (NIAID)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      HIV and hepatitis C virus (HCV) infection are diseases that share the same risk factors and&#xD;
      routes of transmission. For this reason, many people infected with HIV are also infected with&#xD;
      HCV. Interferon (IFN) is a drug used to treat HCV; however, in people coinfected with HIV and&#xD;
      HCV, IFN treatment often does not work well and can cause unwanted side effects. The purpose&#xD;
      of this study was to evaluate the safety, tolerability, and effectiveness of IFN-free HCV&#xD;
      treatment in HIV/HCV coinfected adults who were taking antiretroviral (ARV) therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study evaluated the safety, tolerability, and effectiveness of a combination of drugs to&#xD;
      treat HCV in adults who were coinfected with HIV and HCV. The three drugs were&#xD;
      paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV). In&#xD;
      version 1 of the study, RBV was given to all participants. After revision in version 2, RBV&#xD;
      was given only to participants with HCV genotype 1a; participants with HCV genotype 1b did&#xD;
      not receive RBV.&#xD;
&#xD;
      This study enrolled HCV genotype 1a or 1b and HIV-1 coinfected participants (HCV&#xD;
      treatment-naïve or HCV treatment-experienced) who were on a concurrent integrase inhibitor&#xD;
      (INI)-based (raltegravir [RAL] or dolutegravir [DTG]) or protease inhibitor (PI)-based&#xD;
      (darunavir [DRV] or atazanavir [ATV]) ART regimen. (The ART regimens were not provided by the&#xD;
      study.) The participants were assigned to one of four cohorts (Cohorts A, B, C, and D).&#xD;
      Participants in Cohorts A and B were on INI-based ART; participants in Cohorts C and D, on&#xD;
      PI-based ART. For each group, the study proceeded in two steps: Step 1: on-HCV treatment and&#xD;
      Step 2: post-HCV treatment follow-up. Participants in Cohorts A and C received the HCV drugs&#xD;
      for 24 weeks; participants in Cohorts B and D, for 12 weeks. The target sample size goal was&#xD;
      a total of 100 participants, with 25 participants per cohort.&#xD;
&#xD;
      Total study duration was up to 48 weeks. During Step 1 (on-HCV treatment), all participants&#xD;
      had study visits at Weeks 2, 4, 6, 8, 10, and 12. Participants in Cohorts A and C had&#xD;
      additional Step 1 study visits at Weeks 16, 20, and 24.&#xD;
&#xD;
      All participants had Step 2 (post-treatment follow-up) study visits 4, 12, and 24 weeks after&#xD;
      registration to Step 2. Participants in Cohorts B and D had an additional Step 2 visit 36&#xD;
      weeks after registration to Step 2.&#xD;
&#xD;
      All study visits included a brief physical exam and blood collection. Select study visits&#xD;
      included pregnancy testing for participants able to become pregnant, an electrocardiogram&#xD;
      (EKG), an IFN gamma-induced protein 10 (IP-10) test, and collection of plasma samples.&#xD;
&#xD;
      Participants were able to coenroll in one of two optional substudies. In one substudy,&#xD;
      participants attended two study visits at entry/Day 0 and Week 4 for 12-hour intensive&#xD;
      pharmacokinetic (PK) sampling. In another substudy, participants underwent liver biopsies at&#xD;
      two time points and PK sampling.&#xD;
&#xD;
      Study accrual was terminated early and participants who enrolled continued on study until&#xD;
      completion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study closed to accrual before the planned accrual goal was attained due to the&#xD;
    availability of newer directly-acting antiviral (DAA) treatments for HCV.&#xD;
  </why_stopped>
  <start_date type="Actual">September 16, 2015</start_date>
  <completion_date type="Actual">November 13, 2018</completion_date>
  <primary_completion_date type="Actual">May 17, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response at 12 Weeks After HCV Treatment Discontinuation (SVR12)</measure>
    <time_frame>At 12 weeks after last dose of HCV study treatment. The duration for study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.</time_frame>
    <description>SVR12 was defined as HCV RNA less than the assay LLOQ (&lt;15 IU/mL) at 12 weeks post HCV treatment discontinuation.&#xD;
A two-sided 90% confidence interval was calculated for the percentage of participants with SVR12 response using Clopper-Pearson method.&#xD;
For those whose HCV early responses prior to SVR12 evaluation met the guidelines for HCV Virologic Failure (VF), their SVR12 outcome was defined as non-response. Those missing a HCV RNA result from the week 12 post HCV treatment discontinuation visit (and missing all subsequent evaluations) were considered non-responders. However, if HCV RNA evaluations subsequent to week 12 post treatment discontinuation were non-missing, then the first HCV RNA subsequent to week 12 post treatment discontinuation was instead used to define the primary outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With an Occurrence of Serious Adverse Events (SAEs) as Defined by International Conference on Harmonisation (ICH) Criteria</measure>
    <time_frame>From treatment initiation to 30 days post date of last dose of HCV study treatment (whether planned or premature discontinuation). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.</time_frame>
    <description>Participants who experienced at least one observed SAEs as defined by ICH after initiating HCV study treatment through 30 days post date of last dose of HCV study treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Prematurely Discontinued HCV Study Treatment for Any Reason Other Than HCV Virologic Failure (VF)</measure>
    <time_frame>From treatment initiation to either 24 weeks (for Cohort A and C) or 12 weeks (for Cohort B and D). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.</time_frame>
    <description>HCV VF was defined as follows: confirmed increase from nadir in HCV RNA (defined as two consecutive HCV RNA measurements of &gt;1 log10 IU/mL above nadir) at any time point; failure to achieve HCV RNA &lt;LLOQ (&lt;15 IU/mL) by week 6; confirmed HCV RNA ≥LLOQ (defined as two consecutive HCV RNA measurements ≥LLOQ (≥15 IU/mL)) at any point after HCV RNA &lt;LLOQ during HCV treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With an Occurrence of Signs/Symptoms Grade 3 or Higher</measure>
    <time_frame>From treatment initiation to 30 days post date of last dose of HCV study treatment (whether planned or premature discontinuation). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.</time_frame>
    <description>Participants with signs/symptoms of grade 3 or higher post treatment initiation.&#xD;
Participants with grade 3 sign/symptom prior to treatment initiation must have had one grade higher than pre-treatment to meet this outcome.&#xD;
Severity grading was based on DAIDS AE Grading Table, Version 1.0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With an Occurrence of Diagnoses Leading to Premature HCV Study Treatment or HIV-1 Antiretroviral (ARV) Discontinuation.</measure>
    <time_frame>From treatment initiation to end of study follow-up at 48 weeks.The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively. The duration for ARV treatment for all cohorts was 48 weeks.</time_frame>
    <description>Participants who had diagnoses leading to premature HCV study treatment or HIV-1 ARV discontinuation post treatment initiation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With an Occurrence of Laboratory Abnormality Grade 3 or Higher.</measure>
    <time_frame>From treatment initiation to 30 days post date of last dose of HCV study treatment (whether planned or premature discontinuation). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.</time_frame>
    <description>Participants with an observed laboratory abnormalities grade 3 or higher post treatment initiation.&#xD;
If entry (pre-treatment) lab result was grade 3, then a grade 4 result was required to meet this outcome.&#xD;
Severity grading was based on DAIDS AE Grading Table, Version 1.0.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experienced HIV-1 Virologic Failure (VF)</measure>
    <time_frame>From treatment initiation to 4 weeks after last dose of HCV study treatment. HIV-1 RNA was measured at weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28. The durations for HCV study treatment for Cohorts A/C and Cohorts B/D were 24 and 12 weeks, respectively.</time_frame>
    <description>HIV-1 VF was defined as two consecutive HIV-1 RNA results ≥ 200 copies/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Selected HIV-1 Resistance Mutations Among Participants Who Experience HIV-1 Virologic Failure (VF)</measure>
    <time_frame>At confirmation of HIV-1 virologic failure.</time_frame>
    <description>Participants with one or more genotype mutations in protease conferring major resistance to any HIV-1 Protease Inhibitors (PI) antiretroviral drug, from a plasma sample drawn following confirmed HIV-1 VF outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of Soluble CD14 (sCD14)</measure>
    <time_frame>At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.</time_frame>
    <description>Levels of sCD14. Baseline was defined as the date of first treatment dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Soluble CD14 (sCD14)</measure>
    <time_frame>At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.</time_frame>
    <description>Absolute change from baseline in sCD14 levels in plasma calculated as value at the later time point minus baseline value. Baseline was defined as the date of first treatment dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of IP-10 Concentration.</measure>
    <time_frame>At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.</time_frame>
    <description>Levels of IP-10 (Interferon gamma-induced protein 10) concentration in plasma. Baseline was defined as the date of first treatment dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in IP-10 Concentration.</measure>
    <time_frame>At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.</time_frame>
    <description>Absolute change from baseline in IP-10 (Interferon gamma-induced protein 10) concentration in plasma, calculated as value at the later time point minus baseline value. Baseline was defined as the date of first treatment dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With HCV Mutations Conferring Resistance to Any Component of the HCV Treatment Regimen</measure>
    <time_frame>From treatment initiation to 12 weeks post date of last dose of HCV study treatment. The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.</time_frame>
    <description>Study team decided to remove this secondary outcome measure due to reduced interest in study treatment as a result of development and approval of newer DAA's.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response at 24 Weeks After HCV Treatment Discontinuation (SVR24)</measure>
    <time_frame>At 24 weeks after the date of last dose of HCV study treatment. The duration for study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.</time_frame>
    <description>SVR24 was defined as HCV RNA less than the assay LLOQ (&lt;15 IU/mL) at 24 weeks post treatment discontinuation.&#xD;
A two-sided 90% confidence interval was calculated for the percentage of SVR24 response using method of Clopper-Pearson.&#xD;
For those whose HCV early responses prior to SVR24 evaluation met the guidelines for HCV VF, their SVR24 outcome was defined as non-response. Those missing a HCV RNA result from the week 24 post HCV treatment discontinuation visit (and missing all subsequent evaluations) were considered non-responders. However, if HCV RNA evaluations subsequent to week 24 post treatment discontinuation were non-missing, then the first HCV RNA subsequent to week 24 post treatment discontinuation was instead used to define the primary outcome.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>HIV Infections</condition>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paritaprevir/ritonavir/ombitasvir (PTV/r/OBT)</intervention_name>
    <description>PTV/r/OBT: 150/100/25 mg (two 75/50/12.5 mg fixed-dose combination tablets) orally once a day</description>
    <arm_group_label>Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</arm_group_label>
    <arm_group_label>Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</arm_group_label>
    <arm_group_label>Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</arm_group_label>
    <arm_group_label>Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dasabuvir (DSV)</intervention_name>
    <description>DSV: 250 mg orally twice a day</description>
    <arm_group_label>Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</arm_group_label>
    <arm_group_label>Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</arm_group_label>
    <arm_group_label>Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</arm_group_label>
    <arm_group_label>Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavirin (RBV)</intervention_name>
    <description>RBV: 1,000 or 1,200 mg (weight-based) dosed in two divided doses orally twice a day (all participants (version 1); only participants with HCV genotype 1a (version2))</description>
    <arm_group_label>Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</arm_group_label>
    <arm_group_label>Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</arm_group_label>
    <arm_group_label>Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</arm_group_label>
    <arm_group_label>Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women age greater than or equal to 18 to less than or equal to 70 years at&#xD;
             study entry.&#xD;
&#xD;
          -  Body mass index (BMI) from greater than or equal to 18 to less than 38 kg/m^2 within&#xD;
             42 days of study entry. BMI was calculated as weight measured in kilograms (kg)&#xD;
             divided by the square of height measured in meters (m).&#xD;
&#xD;
          -  HIV-1 infection&#xD;
&#xD;
          -  CD4+ cell count greater than or equal to 200 cells/uL and CD4+ cell percentage greater&#xD;
             than or equal to 14% within 42 days of study entry.&#xD;
&#xD;
          -  On a stable, qualifying ART regimen for at least 8 weeks prior to entry.&#xD;
&#xD;
          -  HIV-1 RNA less than 50 copies/mL for at least 6 months prior to study entry.&#xD;
&#xD;
          -  Presence of chronic HCV infection defined as positive for anti-HCV antibody or HCV RNA&#xD;
             at least 6 months before screening, and positive for HCV RNA at the time of screening;&#xD;
             OR positive for HCV RNA at the time of screening with a liver biopsy consistent with&#xD;
             chronic HCV infection any time prior to study entry.&#xD;
&#xD;
          -  HCV treatment-naïve or unsuccessful treatment with pegylated or standard IFN alfa with&#xD;
             or without RBV. NOTE: No prior exposure to HCV NS3/4A PI (including but not limited to&#xD;
             TVR, BOC, simeprevir), NS5A inhibitors (including but not limited to daclatasvir or&#xD;
             ledipasvir), NS5B NNI or NI inhibitors (including but not limited to sofosbuvir) was&#xD;
             allowed.&#xD;
&#xD;
          -  HCV genotype 1a or 1b infection&#xD;
&#xD;
          -  Serum HCV RNA greater than 10,000 IU/mL obtained within 42 days prior to study entry.&#xD;
&#xD;
          -  The following laboratory values obtained within 42 days prior to study entry.&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) greater than or equal to 750/mm^3&#xD;
&#xD;
               -  Hemoglobin greater than or equal to 12 g/dL for men and greater than or equal to&#xD;
                  11 g/dL for women&#xD;
&#xD;
               -  Platelet count greater than or equal to 90,000/mm^3&#xD;
&#xD;
               -  International normalized ratio (INR) less than or equal to 1.5&#xD;
&#xD;
               -  Participants with known inherited bleeding disorder and INR greater than or equal&#xD;
                  to 1.5 could be enrolled.&#xD;
&#xD;
               -  Calculated creatinine clearance (CrCl) using Cockcroft-Gault method greater than&#xD;
                  or equal to 60 mL/min&#xD;
&#xD;
               -  Alanine aminotransferase (ALT) less than or equal to 7 times the upper limit of&#xD;
                  the normal range (ULN)&#xD;
&#xD;
               -  Aspartate aminotransferase (AST) less than or equal to 7 times the ULN range&#xD;
&#xD;
               -  Total bilirubin less than 3 mg/dL for participants not on ATV and less than 6&#xD;
                  mg/dL for participants on ATV&#xD;
&#xD;
               -  Direct bilirubin less than or equal to 1.5 times the ULN&#xD;
&#xD;
               -  Albumin greater than or equal to 3.5 g/dL&#xD;
&#xD;
               -  Serum alfa-fetoprotein (AFP) less than or equal to 100 ng/mL&#xD;
&#xD;
          -  Classification of liver disease as cirrhotic or non-cirrhotic with no evidence of&#xD;
             hepatocellular carcinoma according to specified criteria.&#xD;
&#xD;
          -  For females of reproductive potential, a negative serum or urine pregnancy test with a&#xD;
             sensitivity of less than or equal to 25 mIU/mL within 42 days prior to study entry.&#xD;
&#xD;
          -  All participants must have agreed not to participate in a conception process (e.g.,&#xD;
             active attempt to become pregnant or to impregnate, sperm donation, in vitro&#xD;
             fertilization).&#xD;
&#xD;
          -  If participating in sexual activity that could lead to pregnancy, the participant (men&#xD;
             and women) had to agree to use two reliable methods of contraception simultaneously.&#xD;
&#xD;
          -  Participants who were not of reproductive potential were eligible without requiring&#xD;
             the use of contraceptives.&#xD;
&#xD;
          -  Ability and willingness of the participant to provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Breastfeeding&#xD;
&#xD;
          -  Pregnant sexual partner for male participants with HCV genotype 1a infection who would&#xD;
             receive RBV. This criterion did not apply to male participants with HCV genotype 1b&#xD;
             infection who would not receive RBV.&#xD;
&#xD;
          -  Known allergy/sensitivity or any hypersensitivity to components of study drugs or&#xD;
             their formulation.&#xD;
&#xD;
          -  Acute or serious illness requiring systemic treatment and/or hospitalization within 42&#xD;
             days prior to study entry.&#xD;
&#xD;
          -  Active hepatitis B infection (positive hepatitis B surface antigen [HBsAg]) within 42&#xD;
             days prior to study entry.&#xD;
&#xD;
          -  History of decompensated liver disease (including but not limited to encephalopathy,&#xD;
             variceal bleeding, or ascites) prior to study entry.&#xD;
&#xD;
          -  Any cause of liver disease other than chronic HCV infection, including but not limited&#xD;
             to the following: hemochromatosis, alpha-1 antitrypsin deficiency, Wilson's disease,&#xD;
             autoimmune hepatitis, alcoholic liver disease, or drug-related liver disease.&#xD;
&#xD;
          -  Uncontrolled or active depression or other psychiatric disorder within 24 weeks prior&#xD;
             to study entry that in the opinion of the site investigator might preclude adherence&#xD;
             to study requirements.&#xD;
&#xD;
          -  Active drug or alcohol use or dependence that, in the opinion of the site&#xD;
             investigator, would interfere with adherence to study requirements.&#xD;
&#xD;
          -  Serious illness including uncontrolled seizure disorders, active coronary artery&#xD;
             disease within 24 weeks prior to study entry, or other chronic medical conditions that&#xD;
             in the opinion of the site investigator might preclude completion of the protocol.&#xD;
&#xD;
          -  Presence of active or acute AIDS-defining opportunistic infections within 12 weeks&#xD;
             prior to study entry.&#xD;
&#xD;
          -  Active or history of malignancy within 5 years prior to study entry other than basal&#xD;
             cell carcinoma of the skin and/or cutaneous Kaposi's sarcoma (KS) and/or cervical or&#xD;
             anal dysplasia or carcinoma in situ.&#xD;
&#xD;
          -  Clinically significant abnormal EKG, or EKG with QT interval corrected for heart rate&#xD;
             (QTc) using Fridericia's correction formula (QTcF) greater than 450 msec within 42&#xD;
             days of study entry.&#xD;
&#xD;
          -  Use of colony stimulating factors, such as granulocyte colony stimulating factor&#xD;
             (GCSF) or erythropoietin within 42 days of study entry.&#xD;
&#xD;
          -  Infection with any HCV genotype other than genotype 1, or mixed genotype infection any&#xD;
             time prior to study entry.&#xD;
&#xD;
          -  History of major organ transplantation with an existing functional graft any time&#xD;
             prior to study entry.&#xD;
&#xD;
          -  History of hemoglobinopathy (e.g., thalassemia) or any other cause of or tendency to&#xD;
             hemolysis any time prior to study entry.&#xD;
&#xD;
          -  Anticoagulants such as Coumadin (Warfarin), Dicumarol, Plavix (Clopidrogel),&#xD;
             low-molecular weight Heparin, Lovenox (Enoxaparin), or Dabigatran (Pradaxa), aspirin,&#xD;
             and Non-steroidal Anti-Inflammatory Drugs (NSAIDs) within 2 weeks prior to entry.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark S. Sulkowski, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alabama CRS</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA CARE Center CRS</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Hospital CRS</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Whitman-Walker Health CRS</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University CRS</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University CRS</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Jersey Medical School Clinical Research Center CRS</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Chelsea CRS</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Clinical Research Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn Therapeutics, CRS</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh CRS</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Miriam Hospital Clinical Research Site (TMH CRS) CRS</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trinity Health and Wellness Center CRS</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston AIDS Research Team CRS</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington AIDS CRS</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104-9929</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Puerto Rico AIDS Clinical Trials Unit CRS</name>
      <address>
        <city>San Juan</city>
        <zip>00935</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://rsc.niaid.nih.gov/sites/default/files/table-for-grading-severity-of-adult-pediatric-adverse-events.pdf</url>
    <description>DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009).</description>
  </link>
  <link>
    <url>http://rsc.niaid.nih.gov/sites/default/files/manual-exped-aes-v2_0.pdf</url>
    <description>Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010.</description>
  </link>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <results_first_submitted>May 16, 2019</results_first_submitted>
  <results_first_submitted_qc>May 16, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 4, 2019</results_first_posted>
  <last_update_submitted>November 2, 2021</last_update_submitted>
  <last_update_submitted_qc>November 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2021</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>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ritonavir</mesh_term>
    <mesh_term>Ribavirin</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 8, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT02194998/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 29, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT02194998/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled from September 2015 to December 2016 at 16 U.S. sites.</recruitment_details>
      <pre_assignment_details>There was no randomization in this study. Participants were stratified according to evidence of cirrhosis (yes versus no). The enrollment to the strata level for cirrhosis=yes was limited to no more than 30% within any particular study cohort.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
          <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
        </group>
        <group group_id="P2">
          <title>Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
          <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
        </group>
        <group group_id="P3">
          <title>Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
          <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
        </group>
        <group group_id="P4">
          <title>Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
          <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>On-HCV Treatment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Did not pick up study medication</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Post-HCV Treatment Follow-Up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="14"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <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="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Participants who initiated study treatment.</population>
      <group_list>
        <group group_id="B1">
          <title>Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
          <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
        </group>
        <group group_id="B2">
          <title>Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
          <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
        </group>
        <group group_id="B3">
          <title>Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
          <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
        </group>
        <group group_id="B4">
          <title>Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
          <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for participants with HCV genotype 1a only; participants with HCV genotype 1b did not receive RBV).</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="21"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="15"/>
            <count group_id="B4" value="4"/>
            <count group_id="B5" value="45"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="4"/>
                    <count group_id="B5" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48" lower_limit="40" upper_limit="49"/>
                    <measurement group_id="B2" value="50" lower_limit="49" upper_limit="54"/>
                    <measurement group_id="B3" value="58" lower_limit="55" upper_limit="61"/>
                    <measurement group_id="B4" value="55" lower_limit="49" upper_limit="59"/>
                    <measurement group_id="B5" value="53" lower_limit="47" upper_limit="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="4"/>
                    <count group_id="B5" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>30-39 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>40-49 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>50-59 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>60-69 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="10"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="4"/>
                    <count group_id="B5" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="32"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="4"/>
                    <count group_id="B5" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>White Non-Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black Non-Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic (Regardless of Race)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="16"/>
                  </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>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="4"/>
                    <count group_id="B5" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>CD4 Count</title>
          <population>All participants who initiated treatment and had baseline CD4 result available.</population>
          <units>cells/mm^3</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="4"/>
                    <count group_id="B5" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="752" lower_limit="467" upper_limit="1064"/>
                    <measurement group_id="B2" value="674" lower_limit="528" upper_limit="726"/>
                    <measurement group_id="B3" value="646" lower_limit="466" upper_limit="849"/>
                    <measurement group_id="B4" value="525" lower_limit="404" upper_limit="683"/>
                    <measurement group_id="B5" value="665" lower_limit="464" upper_limit="894"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HIV-1 RNA</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="4"/>
                    <count group_id="B5" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Greater than 40 copies/mL</title>
                  <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>
                  <title>Less than or equal to 40 copies/mL</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV RNA, continuous</title>
          <population>All participants who initiated treatment and had baseline HCV RNA result available.</population>
          <units>Log10 IU/mL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="14"/>
                    <count group_id="B4" value="4"/>
                    <count group_id="B5" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.5" lower_limit="6.0" upper_limit="6.8"/>
                    <measurement group_id="B2" value="5.9" lower_limit="5.1" upper_limit="6.3"/>
                    <measurement group_id="B3" value="6.5" lower_limit="5.8" upper_limit="7.0"/>
                    <measurement group_id="B4" value="6.2" lower_limit="5.9" upper_limit="6.5"/>
                    <measurement group_id="B5" value="6.4" lower_limit="5.8" upper_limit="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV RNA, categorized</title>
          <population>All participants who initiated treatment and had baseline HCV RNA result available.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="14"/>
                    <count group_id="B4" value="4"/>
                    <count group_id="B5" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>≥6 million IU/mL</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&lt;6 million IU/mL</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV Genotype</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="4"/>
                    <count group_id="B5" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>1A</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1B</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="0"/>
                    <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_list>
        </measure>
        <measure>
          <title>HCV Treatment Experience</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="4"/>
                    <count group_id="B5" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Naive</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Experienced</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cirrhosis Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="4"/>
                    <count group_id="B5" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Cirrhotic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-Cirrhotic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Sustained Virologic Response at 12 Weeks After HCV Treatment Discontinuation (SVR12)</title>
        <description>SVR12 was defined as HCV RNA less than the assay LLOQ (&lt;15 IU/mL) at 12 weeks post HCV treatment discontinuation.&#xD;
A two-sided 90% confidence interval was calculated for the percentage of participants with SVR12 response using Clopper-Pearson method.&#xD;
For those whose HCV early responses prior to SVR12 evaluation met the guidelines for HCV Virologic Failure (VF), their SVR12 outcome was defined as non-response. Those missing a HCV RNA result from the week 12 post HCV treatment discontinuation visit (and missing all subsequent evaluations) were considered non-responders. However, if HCV RNA evaluations subsequent to week 12 post treatment discontinuation were non-missing, then the first HCV RNA subsequent to week 12 post treatment discontinuation was instead used to define the primary outcome.</description>
        <time_frame>At 12 weeks after last dose of HCV study treatment. The duration for study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.</time_frame>
        <population>Participants who initiated study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O2">
            <title>Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O3">
            <title>Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O4">
            <title>Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response at 12 Weeks After HCV Treatment Discontinuation (SVR12)</title>
          <description>SVR12 was defined as HCV RNA less than the assay LLOQ (&lt;15 IU/mL) at 12 weeks post HCV treatment discontinuation.&#xD;
A two-sided 90% confidence interval was calculated for the percentage of participants with SVR12 response using Clopper-Pearson method.&#xD;
For those whose HCV early responses prior to SVR12 evaluation met the guidelines for HCV Virologic Failure (VF), their SVR12 outcome was defined as non-response. Those missing a HCV RNA result from the week 12 post HCV treatment discontinuation visit (and missing all subsequent evaluations) were considered non-responders. However, if HCV RNA evaluations subsequent to week 12 post treatment discontinuation were non-missing, then the first HCV RNA subsequent to week 12 post treatment discontinuation was instead used to define the primary outcome.</description>
          <population>Participants who initiated study treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.2" lower_limit="79.3" upper_limit="99.8"/>
                    <measurement group_id="O2" value="60" lower_limit="18.9" upper_limit="92.4"/>
                    <measurement group_id="O3" value="100" lower_limit="81.9" upper_limit="100"/>
                    <measurement group_id="O4" value="100" lower_limit="47.3" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Null Hypothesis: Cohort A's SVR12 rate &lt;= 70%.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.</non_inferiority_desc>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>No adjustments for multiple comparisons.</p_value_desc>
            <method>One-Sided Exact Binomial Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null Hypothesis: Cohort B's SVR12 rate &lt;= 70%.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.</non_inferiority_desc>
            <p_value>0.47</p_value>
            <p_value_desc>No adjustments for multiple comparisons.</p_value_desc>
            <method>One-Sided Exact Binomial Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Null Hypothesis: Cohort C's SVR12 rate &lt;= 70%.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.</non_inferiority_desc>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>No adjustments for multiple comparisons.</p_value_desc>
            <method>One-Sided Exact Binomial Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Null Hypothesis: Cohort D's SVR12 rate &lt;= 70%.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.</non_inferiority_desc>
            <p_value>0.24</p_value>
            <p_value_desc>No adjustments for multiple comparisons.</p_value_desc>
            <method>One-Sided Exact Binomial Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With an Occurrence of Serious Adverse Events (SAEs) as Defined by International Conference on Harmonisation (ICH) Criteria</title>
        <description>Participants who experienced at least one observed SAEs as defined by ICH after initiating HCV study treatment through 30 days post date of last dose of HCV study treatment.</description>
        <time_frame>From treatment initiation to 30 days post date of last dose of HCV study treatment (whether planned or premature discontinuation). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.</time_frame>
        <population>Participants who initiated study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O2">
            <title>Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O3">
            <title>Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O4">
            <title>Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Occurrence of Serious Adverse Events (SAEs) as Defined by International Conference on Harmonisation (ICH) Criteria</title>
          <description>Participants who experienced at least one observed SAEs as defined by ICH after initiating HCV study treatment through 30 days post date of last dose of HCV study treatment.</description>
          <population>Participants who initiated study treatment.</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="21"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Prematurely Discontinued HCV Study Treatment for Any Reason Other Than HCV Virologic Failure (VF)</title>
        <description>HCV VF was defined as follows: confirmed increase from nadir in HCV RNA (defined as two consecutive HCV RNA measurements of &gt;1 log10 IU/mL above nadir) at any time point; failure to achieve HCV RNA &lt;LLOQ (&lt;15 IU/mL) by week 6; confirmed HCV RNA ≥LLOQ (defined as two consecutive HCV RNA measurements ≥LLOQ (≥15 IU/mL)) at any point after HCV RNA &lt;LLOQ during HCV treatment</description>
        <time_frame>From treatment initiation to either 24 weeks (for Cohort A and C) or 12 weeks (for Cohort B and D). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.</time_frame>
        <population>Participants who initiated study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O2">
            <title>Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O3">
            <title>Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O4">
            <title>Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Prematurely Discontinued HCV Study Treatment for Any Reason Other Than HCV Virologic Failure (VF)</title>
          <description>HCV VF was defined as follows: confirmed increase from nadir in HCV RNA (defined as two consecutive HCV RNA measurements of &gt;1 log10 IU/mL above nadir) at any time point; failure to achieve HCV RNA &lt;LLOQ (&lt;15 IU/mL) by week 6; confirmed HCV RNA ≥LLOQ (defined as two consecutive HCV RNA measurements ≥LLOQ (≥15 IU/mL)) at any point after HCV RNA &lt;LLOQ during HCV treatment</description>
          <population>Participants who initiated study treatment.</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="21"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With an Occurrence of Signs/Symptoms Grade 3 or Higher</title>
        <description>Participants with signs/symptoms of grade 3 or higher post treatment initiation.&#xD;
Participants with grade 3 sign/symptom prior to treatment initiation must have had one grade higher than pre-treatment to meet this outcome.&#xD;
Severity grading was based on DAIDS AE Grading Table, Version 1.0.</description>
        <time_frame>From treatment initiation to 30 days post date of last dose of HCV study treatment (whether planned or premature discontinuation). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.</time_frame>
        <population>Participants who initiated study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O2">
            <title>Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O3">
            <title>Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O4">
            <title>Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Occurrence of Signs/Symptoms Grade 3 or Higher</title>
          <description>Participants with signs/symptoms of grade 3 or higher post treatment initiation.&#xD;
Participants with grade 3 sign/symptom prior to treatment initiation must have had one grade higher than pre-treatment to meet this outcome.&#xD;
Severity grading was based on DAIDS AE Grading Table, Version 1.0.</description>
          <population>Participants who initiated study treatment.</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="21"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With an Occurrence of Diagnoses Leading to Premature HCV Study Treatment or HIV-1 Antiretroviral (ARV) Discontinuation.</title>
        <description>Participants who had diagnoses leading to premature HCV study treatment or HIV-1 ARV discontinuation post treatment initiation.</description>
        <time_frame>From treatment initiation to end of study follow-up at 48 weeks.The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively. The duration for ARV treatment for all cohorts was 48 weeks.</time_frame>
        <population>Participants who initiated study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O2">
            <title>Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O3">
            <title>Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O4">
            <title>Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Occurrence of Diagnoses Leading to Premature HCV Study Treatment or HIV-1 Antiretroviral (ARV) Discontinuation.</title>
          <description>Participants who had diagnoses leading to premature HCV study treatment or HIV-1 ARV discontinuation post treatment initiation.</description>
          <population>Participants who initiated study treatment.</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="21"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With an Occurrence of Laboratory Abnormality Grade 3 or Higher.</title>
        <description>Participants with an observed laboratory abnormalities grade 3 or higher post treatment initiation.&#xD;
If entry (pre-treatment) lab result was grade 3, then a grade 4 result was required to meet this outcome.&#xD;
Severity grading was based on DAIDS AE Grading Table, Version 1.0.</description>
        <time_frame>From treatment initiation to 30 days post date of last dose of HCV study treatment (whether planned or premature discontinuation). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.</time_frame>
        <population>Participants who initiated study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O2">
            <title>Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O3">
            <title>Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O4">
            <title>Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Occurrence of Laboratory Abnormality Grade 3 or Higher.</title>
          <description>Participants with an observed laboratory abnormalities grade 3 or higher post treatment initiation.&#xD;
If entry (pre-treatment) lab result was grade 3, then a grade 4 result was required to meet this outcome.&#xD;
Severity grading was based on DAIDS AE Grading Table, Version 1.0.</description>
          <population>Participants who initiated study treatment.</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="21"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experienced HIV-1 Virologic Failure (VF)</title>
        <description>HIV-1 VF was defined as two consecutive HIV-1 RNA results ≥ 200 copies/mL.</description>
        <time_frame>From treatment initiation to 4 weeks after last dose of HCV study treatment. HIV-1 RNA was measured at weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28. The durations for HCV study treatment for Cohorts A/C and Cohorts B/D were 24 and 12 weeks, respectively.</time_frame>
        <population>Participants who initiated study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O2">
            <title>Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O3">
            <title>Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O4">
            <title>Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced HIV-1 Virologic Failure (VF)</title>
          <description>HIV-1 VF was defined as two consecutive HIV-1 RNA results ≥ 200 copies/mL.</description>
          <population>Participants who initiated study treatment.</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="21"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Selected HIV-1 Resistance Mutations Among Participants Who Experience HIV-1 Virologic Failure (VF)</title>
        <description>Participants with one or more genotype mutations in protease conferring major resistance to any HIV-1 Protease Inhibitors (PI) antiretroviral drug, from a plasma sample drawn following confirmed HIV-1 VF outcome.</description>
        <time_frame>At confirmation of HIV-1 virologic failure.</time_frame>
        <population>Participants who experienced confirmed HIV-1 virologic failure (a single participant from Cohort D [PI-based + (3 DAA: 12 wks)]).</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O2">
            <title>Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O3">
            <title>Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O4">
            <title>Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Selected HIV-1 Resistance Mutations Among Participants Who Experience HIV-1 Virologic Failure (VF)</title>
          <description>Participants with one or more genotype mutations in protease conferring major resistance to any HIV-1 Protease Inhibitors (PI) antiretroviral drug, from a plasma sample drawn following confirmed HIV-1 VF outcome.</description>
          <population>Participants who experienced confirmed HIV-1 virologic failure (a single participant from Cohort D [PI-based + (3 DAA: 12 wks)]).</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="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <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>Levels of Soluble CD14 (sCD14)</title>
        <description>Levels of sCD14. Baseline was defined as the date of first treatment dose.</description>
        <time_frame>At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.</time_frame>
        <population>All participants who initiated treatment and had available data at the study visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O2">
            <title>Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O3">
            <title>Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O4">
            <title>Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
        </group_list>
        <measure>
          <title>Levels of Soluble CD14 (sCD14)</title>
          <description>Levels of sCD14. Baseline was defined as the date of first treatment dose.</description>
          <population>All participants who initiated treatment and had available data at the study visit.</population>
          <units>ng/mL</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="21"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>sCD14 at Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1,832.0" lower_limit="1,401.5" upper_limit="2,401.9"/>
                    <measurement group_id="O2" value="2,226.8" lower_limit="2,161.1" upper_limit="2,289.0"/>
                    <measurement group_id="O3" value="3,157.0" lower_limit="2,293.4" upper_limit="4,135.1"/>
                    <measurement group_id="O4" value="3,092.0" lower_limit="2,271.8" upper_limit="4,711.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>sCD14 at EOT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2,126.5" lower_limit="1,663.4" upper_limit="4,029.7"/>
                    <measurement group_id="O2" value="1,132.8" lower_limit="1,113.8" upper_limit="1,151.7"/>
                    <measurement group_id="O3" value="2,421.1" lower_limit="1,862.2" upper_limit="4,362.0"/>
                    <measurement group_id="O4" value="2,801.3" lower_limit="1,888.9" upper_limit="5,114.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>sCD14 at 12 weeks post EOT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1,977.3" lower_limit="1,374.8" upper_limit="3,458.1"/>
                    <measurement group_id="O2" value="1,367.4" lower_limit="792.3" upper_limit="1,470.7"/>
                    <measurement group_id="O3" value="3,424.5" lower_limit="1,765.8" upper_limit="3,908.0"/>
                    <measurement group_id="O4" value="2,608.3" lower_limit="1,521.9" upper_limit="3,286.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Soluble CD14 (sCD14)</title>
        <description>Absolute change from baseline in sCD14 levels in plasma calculated as value at the later time point minus baseline value. Baseline was defined as the date of first treatment dose.</description>
        <time_frame>At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.</time_frame>
        <population>All participants who initiated treatment and had available data at baseline and the respective post-baseline visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O2">
            <title>Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O3">
            <title>Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O4">
            <title>Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Soluble CD14 (sCD14)</title>
          <description>Absolute change from baseline in sCD14 levels in plasma calculated as value at the later time point minus baseline value. Baseline was defined as the date of first treatment dose.</description>
          <population>All participants who initiated treatment and had available data at baseline and the respective post-baseline visit.</population>
          <units>ng/mL</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="21"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from baseline to EOT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="307.6" lower_limit="-190.4" upper_limit="1,752.6"/>
                    <measurement group_id="O2" value="-1,063.2" lower_limit="-1,147.8" upper_limit="-978.6"/>
                    <measurement group_id="O3" value="-380.3" lower_limit="-1,488.0" upper_limit="887.8"/>
                    <measurement group_id="O4" value="318.2" lower_limit="-2,003.7" upper_limit="2,023.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 12 weeks post EOT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="145.2" lower_limit="-173.6" upper_limit="526.7"/>
                    <measurement group_id="O2" value="-894.2" lower_limit="-1,524.2" upper_limit="-659.6"/>
                    <measurement group_id="O3" value="-22.6" lower_limit="-593.8" upper_limit="828.5"/>
                    <measurement group_id="O4" value="-987.0" lower_limit="-1,691.8" upper_limit="-483.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Levels of IP-10 Concentration.</title>
        <description>Levels of IP-10 (Interferon gamma-induced protein 10) concentration in plasma. Baseline was defined as the date of first treatment dose.</description>
        <time_frame>At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.</time_frame>
        <population>All participants who initiated treatment and had available data at the study visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O2">
            <title>Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O3">
            <title>Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O4">
            <title>Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
        </group_list>
        <measure>
          <title>Levels of IP-10 Concentration.</title>
          <description>Levels of IP-10 (Interferon gamma-induced protein 10) concentration in plasma. Baseline was defined as the date of first treatment dose.</description>
          <population>All participants who initiated treatment and had available data at the study visit.</population>
          <units>pg/mL</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="21"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IP-10 at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="379" lower_limit="172.7" upper_limit="537.8"/>
                    <measurement group_id="O2" value="120.2" lower_limit="82.7" upper_limit="249.5"/>
                    <measurement group_id="O3" value="225.5" lower_limit="119.9" upper_limit="628"/>
                    <measurement group_id="O4" value="196.4" lower_limit="107.6" upper_limit="382.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IP-10 at EOT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.9" lower_limit="62.8" upper_limit="184"/>
                    <measurement group_id="O2" value="60.4" lower_limit="34.6" upper_limit="86.3"/>
                    <measurement group_id="O3" value="76.6" lower_limit="52.2" upper_limit="124.2"/>
                    <measurement group_id="O4" value="182.6" lower_limit="117.6" upper_limit="481.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IP-10 at 12 weeks post EOT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.6" lower_limit="68.3" upper_limit="190.2"/>
                    <measurement group_id="O2" value="85.5" lower_limit="33" upper_limit="92.8"/>
                    <measurement group_id="O3" value="82.5" lower_limit="71.9" upper_limit="142.1"/>
                    <measurement group_id="O4" value="159.5" lower_limit="81.5" upper_limit="238.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in IP-10 Concentration.</title>
        <description>Absolute change from baseline in IP-10 (Interferon gamma-induced protein 10) concentration in plasma, calculated as value at the later time point minus baseline value. Baseline was defined as the date of first treatment dose.</description>
        <time_frame>At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.</time_frame>
        <population>All participants who initiated treatment and had available data at baseline and the respective post-baseline visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O2">
            <title>Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O3">
            <title>Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O4">
            <title>Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in IP-10 Concentration.</title>
          <description>Absolute change from baseline in IP-10 (Interferon gamma-induced protein 10) concentration in plasma, calculated as value at the later time point minus baseline value. Baseline was defined as the date of first treatment dose.</description>
          <population>All participants who initiated treatment and had available data at baseline and the respective post-baseline visit.</population>
          <units>pg/mL</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="21"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from baseline to EOT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-244.4" lower_limit="-333.1" upper_limit="-87"/>
                    <measurement group_id="O2" value="-22.2" lower_limit="-32.2" upper_limit="-12.2"/>
                    <measurement group_id="O3" value="-116" lower_limit="-201" upper_limit="-49.4"/>
                    <measurement group_id="O4" value="-61.1" lower_limit="-263.5" upper_limit="372"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 12 weeks post EOT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-127" lower_limit="-301.9" upper_limit="-55"/>
                    <measurement group_id="O2" value="-29.1" lower_limit="-32.9" upper_limit="-13.9"/>
                    <measurement group_id="O3" value="-83.1" lower_limit="-184.5" upper_limit="-53.3"/>
                    <measurement group_id="O4" value="-114.9" lower_limit="-261.7" upper_limit="91.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With HCV Mutations Conferring Resistance to Any Component of the HCV Treatment Regimen</title>
        <description>Study team decided to remove this secondary outcome measure due to reduced interest in study treatment as a result of development and approval of newer DAA's.</description>
        <time_frame>From treatment initiation to 12 weeks post date of last dose of HCV study treatment. The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.</time_frame>
        <population>No participants are included in this analysis. The outcome measure was withdrawn and no specimen testing was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O2">
            <title>Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O3">
            <title>Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O4">
            <title>Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With HCV Mutations Conferring Resistance to Any Component of the HCV Treatment Regimen</title>
          <description>Study team decided to remove this secondary outcome measure due to reduced interest in study treatment as a result of development and approval of newer DAA's.</description>
          <population>No participants are included in this analysis. The outcome measure was withdrawn and no specimen testing was performed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Sustained Virologic Response at 24 Weeks After HCV Treatment Discontinuation (SVR24)</title>
        <description>SVR24 was defined as HCV RNA less than the assay LLOQ (&lt;15 IU/mL) at 24 weeks post treatment discontinuation.&#xD;
A two-sided 90% confidence interval was calculated for the percentage of SVR24 response using method of Clopper-Pearson.&#xD;
For those whose HCV early responses prior to SVR24 evaluation met the guidelines for HCV VF, their SVR24 outcome was defined as non-response. Those missing a HCV RNA result from the week 24 post HCV treatment discontinuation visit (and missing all subsequent evaluations) were considered non-responders. However, if HCV RNA evaluations subsequent to week 24 post treatment discontinuation were non-missing, then the first HCV RNA subsequent to week 24 post treatment discontinuation was instead used to define the primary outcome.</description>
        <time_frame>At 24 weeks after the date of last dose of HCV study treatment. The duration for study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.</time_frame>
        <population>Participants who initiated study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O2">
            <title>Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O3">
            <title>Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
          <group group_id="O4">
            <title>Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
            <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response at 24 Weeks After HCV Treatment Discontinuation (SVR24)</title>
          <description>SVR24 was defined as HCV RNA less than the assay LLOQ (&lt;15 IU/mL) at 24 weeks post treatment discontinuation.&#xD;
A two-sided 90% confidence interval was calculated for the percentage of SVR24 response using method of Clopper-Pearson.&#xD;
For those whose HCV early responses prior to SVR24 evaluation met the guidelines for HCV VF, their SVR24 outcome was defined as non-response. Those missing a HCV RNA result from the week 24 post HCV treatment discontinuation visit (and missing all subsequent evaluations) were considered non-responders. However, if HCV RNA evaluations subsequent to week 24 post treatment discontinuation were non-missing, then the first HCV RNA subsequent to week 24 post treatment discontinuation was instead used to define the primary outcome.</description>
          <population>Participants who initiated study treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.5" lower_limit="72.9" upper_limit="98.3"/>
                    <measurement group_id="O2" value="60" lower_limit="18.9" upper_limit="92.4"/>
                    <measurement group_id="O3" value="93.3" lower_limit="72.1" upper_limit="99.7"/>
                    <measurement group_id="O4" value="100" lower_limit="47.3" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Null Hypothesis: Cohort A's SVR24 rate &lt;= 70%.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.</non_inferiority_desc>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>No adjustments for multiple comparisons.</p_value_desc>
            <method>One-Sided Exact Binomial Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null Hypothesis: Cohort B's SVR24 rate &lt;= 70%.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.</non_inferiority_desc>
            <p_value>0.47</p_value>
            <p_value_desc>No adjustments for multiple comparisons.</p_value_desc>
            <method>One-Sided Exact Binomial Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Null Hypothesis: Cohort C's SVR24 rate &lt;= 70%.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.</non_inferiority_desc>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>No adjustments for multiple comparisons.</p_value_desc>
            <method>One-Sided Exact Binomial Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Null Hypothesis: Cohort D's SVR24 rate &lt;= 70%.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.</non_inferiority_desc>
            <p_value>0.24</p_value>
            <p_value_desc>No adjustments for multiple comparisons.</p_value_desc>
            <method>One-Sided Exact Binomial Test</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From treatment initiation to off study at 48 weeks.</time_frame>
      <desc>At entry, all signs/symptoms and selected laboratory values were collected, regardless of grade. Post-entry, signs/symptoms of ≥ Grade 2 and ALT values of ≥ Grade 3 were collected. Signs/symptoms that lead to change in treatment, selected laboratory values, and events that lead to HIV or HCV treatment discontinuation or that meet expedited AE or ICH SAE guidelines were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
          <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
        </group>
        <group group_id="E2">
          <title>Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
          <description>Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
        </group>
        <group group_id="E3">
          <title>Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]</title>
          <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
        </group>
        <group group_id="E4">
          <title>Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]</title>
          <description>Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 22.0</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="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 22.0</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="21" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Secretion discharge</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Latent syphilis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Wound dehiscence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Blood bicarbonate decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Blood glucose decreased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Blood potassium decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Blood potassium increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Blood sodium decreased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Blood uric acid increased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Haemoglobin abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Troponin I increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </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="4" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Joint stiffness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Burning sensation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Bipolar disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Drug dependence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nocturia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Respiratory tract congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash generalised</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
              </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>In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>ACTG Clinicaltrials.gov Coordinator</name_or_title>
      <organization>ACTG Network Coordinating Center, Social and Scientific Systems, Inc.</organization>
      <phone>(301) 628-3313</phone>
      <email>ACTGCT.Gov@s-3.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/NCT02194998
org study id: A5329
secondary id: 11935
nct id: NCT02194998
lead sponsor: 
has dmc: Yes
HIV and hepatitis C virus (HCV) infection are diseases that share the same risk factors and
      routes of transmission. For this reason, many people infected with HIV are also infected with
      HCV. Interferon (IFN) is a drug used to treat HCV; however, in people coinfected with HIV and
      HCV, IFN treatment often does not work well and can cause unwanted side effects. The purpose
      of this study was to evaluate the safety, tolerability, and effectiveness of IFN-free HCV
      treatment in HIV/HCV coinfected adults who were taking antiretroviral (ARV) therapy.
This study evaluated the safety, tolerability, and effectiveness of a combination of drugs to
      treat HCV in adults who were coinfected with HIV and HCV. The three drugs were
      paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV). In
      version 1 of the study, RBV was given to all participants. After revision in version 2, RBV
      was given only to participants with HCV genotype 1a; participants with HCV genotype 1b did
      not receive RBV.

      This study enrolled HCV genotype 1a or 1b and HIV-1 coinfected participants (HCV
      treatment-naïve or HCV treatment-experienced) who were on a concurrent integrase inhibitor
      (INI)-based (raltegravir [RAL] or dolutegravir [DTG]) or protease inhibitor (PI)-based
      (darunavir [DRV] or atazanavir [ATV]) ART regimen. (The ART regimens were not provided by the
      study.) The participants were assigned to one of four cohorts (Cohorts A, B, C, and D).
      Participants in Cohorts A and B were on INI-based ART; participants in Cohorts C and D, on
      PI-based ART. For each group, the study proceeded in two steps: Step 1: on-HCV treatment and
      Step 2: post-HCV treatment follow-up. Participants in Cohorts A and C received the HCV drugs
      for 24 weeks; participants in Cohorts B and D, for 12 weeks. The target sample size goal was
      a total of 100 participants, with 25 participants per cohort.

      Total study duration was up to 48 weeks. During Step 1 (on-HCV treatment), all participants
      had study visits at Weeks 2, 4, 6, 8, 10, and 12. Participants in Cohorts A and C had
      additional Step 1 study visits at Weeks 16, 20, and 24.

      All participants had Step 2 (post-treatment follow-up) study visits 4, 12, and 24 weeks after
      registration to Step 2. Participants in Cohorts B and D had an additional Step 2 visit 36
      weeks after registration to Step 2.

      All study visits included a brief physical exam and blood collection. Select study visits
      included pregnancy testing for participants able to become pregnant, an electrocardiogram
      (EKG), an IFN gamma-induced protein 10 (IP-10) test, and collection of plasma samples.

      Participants were able to coenroll in one of two optional substudies. In one substudy,
      participants attended two study visits at entry/Day 0 and Week 4 for 12-hour intensive
      pharmacokinetic (PK) sampling. In another substudy, participants underwent liver biopsies at
      two time points and PK sampling.

      Study accrual was terminated early and participants who enrolled continued on study until
      completion.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Sustained Virologic Response at 12 Weeks After HCV Treatment Discontinuation (SVR12)
time frame: At 12 weeks after last dose of HCV study treatment. The duration for study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
description: SVR12 was defined as HCV RNA less than the assay LLOQ (<15 IU/mL) at 12 weeks post HCV treatment discontinuation.
A two-sided 90% confidence interval was calculated for the percentage of participants with SVR12 response using Clopper-Pearson method.
For those whose HCV early responses prior to SVR12 evaluation met the guidelines for HCV Virologic Failure (VF), their SVR12 outcome was defined as non-response. Those missing a HCV RNA result from the week 12 post HCV treatment discontinuation visit (and missing all subsequent evaluations) were considered non-responders. However, if HCV RNA evaluations subsequent to week 12 post treatment discontinuation were non-missing, then the first HCV RNA subsequent to week 12 post treatment discontinuation was instead used to define the primary outcome.
measure: Number of Participants With an Occurrence of Serious Adverse Events (SAEs) as Defined by International Conference on Harmonisation (ICH) Criteria
time frame: From treatment initiation to 30 days post date of last dose of HCV study treatment (whether planned or premature discontinuation). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
description: Participants who experienced at least one observed SAEs as defined by ICH after initiating HCV study treatment through 30 days post date of last dose of HCV study treatment.
measure: Number of Participants Who Prematurely Discontinued HCV Study Treatment for Any Reason Other Than HCV Virologic Failure (VF)
time frame: From treatment initiation to either 24 weeks (for Cohort A and C) or 12 weeks (for Cohort B and D). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
description: HCV VF was defined as follows: confirmed increase from nadir in HCV RNA (defined as two consecutive HCV RNA measurements of >1 log10 IU/mL above nadir) at any time point; failure to achieve HCV RNA <LLOQ (<15 IU/mL) by week 6; confirmed HCV RNA ≥LLOQ (defined as two consecutive HCV RNA measurements ≥LLOQ (≥15 IU/mL)) at any point after HCV RNA <LLOQ during HCV treatment
measure: Number of Participants With an Occurrence of Signs/Symptoms Grade 3 or Higher
time frame: From treatment initiation to 30 days post date of last dose of HCV study treatment (whether planned or premature discontinuation). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
description: Participants with signs/symptoms of grade 3 or higher post treatment initiation.
Participants with grade 3 sign/symptom prior to treatment initiation must have had one grade higher than pre-treatment to meet this outcome.
Severity grading was based on DAIDS AE Grading Table, Version 1.0.
measure: Number of Participants With an Occurrence of Diagnoses Leading to Premature HCV Study Treatment or HIV-1 Antiretroviral (ARV) Discontinuation.
time frame: From treatment initiation to end of study follow-up at 48 weeks.The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively. The duration for ARV treatment for all cohorts was 48 weeks.
description: Participants who had diagnoses leading to premature HCV study treatment or HIV-1 ARV discontinuation post treatment initiation.
measure: Number of Participants With an Occurrence of Laboratory Abnormality Grade 3 or Higher.
time frame: From treatment initiation to 30 days post date of last dose of HCV study treatment (whether planned or premature discontinuation). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
description: Participants with an observed laboratory abnormalities grade 3 or higher post treatment initiation.
If entry (pre-treatment) lab result was grade 3, then a grade 4 result was required to meet this outcome.
Severity grading was based on DAIDS AE Grading Table, Version 1.0.
measure: Number of Participants Who Experienced HIV-1 Virologic Failure (VF)
time frame: From treatment initiation to 4 weeks after last dose of HCV study treatment. HIV-1 RNA was measured at weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28. The durations for HCV study treatment for Cohorts A/C and Cohorts B/D were 24 and 12 weeks, respectively.
description: HIV-1 VF was defined as two consecutive HIV-1 RNA results ≥ 200 copies/mL.
measure: Number of Participants With Selected HIV-1 Resistance Mutations Among Participants Who Experience HIV-1 Virologic Failure (VF)
time frame: At confirmation of HIV-1 virologic failure.
description: Participants with one or more genotype mutations in protease conferring major resistance to any HIV-1 Protease Inhibitors (PI) antiretroviral drug, from a plasma sample drawn following confirmed HIV-1 VF outcome.
measure: Levels of Soluble CD14 (sCD14)
time frame: At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
description: Levels of sCD14. Baseline was defined as the date of first treatment dose.
measure: Change in Soluble CD14 (sCD14)
time frame: At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
description: Absolute change from baseline in sCD14 levels in plasma calculated as value at the later time point minus baseline value. Baseline was defined as the date of first treatment dose.
measure: Levels of IP-10 Concentration.
time frame: At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
description: Levels of IP-10 (Interferon gamma-induced protein 10) concentration in plasma. Baseline was defined as the date of first treatment dose.
measure: Change in IP-10 Concentration.
time frame: At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
description: Absolute change from baseline in IP-10 (Interferon gamma-induced protein 10) concentration in plasma, calculated as value at the later time point minus baseline value. Baseline was defined as the date of first treatment dose.
measure: Number of Participants With HCV Mutations Conferring Resistance to Any Component of the HCV Treatment Regimen
time frame: From treatment initiation to 12 weeks post date of last dose of HCV study treatment. The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
description: Study team decided to remove this secondary outcome measure due to reduced interest in study treatment as a result of development and approval of newer DAA's.
measure: Percentage of Participants With Sustained Virologic Response at 24 Weeks After HCV Treatment Discontinuation (SVR24)
time frame: At 24 weeks after the date of last dose of HCV study treatment. The duration for study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.
description: SVR24 was defined as HCV RNA less than the assay LLOQ (<15 IU/mL) at 24 weeks post treatment discontinuation.
A two-sided 90% confidence interval was calculated for the percentage of SVR24 response using method of Clopper-Pearson.
For those whose HCV early responses prior to SVR24 evaluation met the guidelines for HCV VF, their SVR24 outcome was defined as non-response. Those missing a HCV RNA result from the week 24 post HCV treatment discontinuation visit (and missing all subsequent evaluations) were considered non-responders. However, if HCV RNA evaluations subsequent to week 24 post treatment discontinuation were non-missing, then the first HCV RNA subsequent to week 24 post treatment discontinuation was instead used to define the primary outcome.
arm group label: Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]
arm group type: Experimental
description: Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
arm group label: Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]
arm group type: Experimental
description: Participants took an INI-based (RAL or DTG) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
arm group label: Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]
arm group type: Experimental
description: Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 24 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
arm group label: Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]
arm group type: Experimental
description: Participants took a PI-based (DRV or ATV) ART regimen for HIV-1 and received the following medications for 12 weeks: paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV) (RBV for all participants (version 1) and only for participants with HCV genotype 1a (version 2)).
intervention type: Drug
intervention name: Paritaprevir/ritonavir/ombitasvir (PTV/r/OBT)
description: PTV/r/OBT: 150/100/25 mg (two 75/50/12.5 mg fixed-dose combination tablets) orally once a day
arm group label: Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]
arm group label: Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]
arm group label: Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]
arm group label: Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]
intervention type: Drug
intervention name: Dasabuvir (DSV)
description: DSV: 250 mg orally twice a day
arm group label: Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]
arm group label: Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]
arm group label: Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]
arm group label: Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]
intervention type: Drug
intervention name: Ribavirin (RBV)
description: RBV: 1,000 or 1,200 mg (weight-based) dosed in two divided doses orally twice a day (all participants (version 1); only participants with HCV genotype 1a (version2))
arm group label: Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]
arm group label: Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]
arm group label: Cohort C [PI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks]
arm group label: Cohort D [PI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks]
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Mark S. Sulkowski, MD
role: Study Chair
affiliation: Johns Hopkins University
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country: Puerto Rico
country: United States
url: http://rsc.niaid.nih.gov/sites/default/files/table-for-grading-severity-of-adult-pediatric-adverse-events.pdf
description: DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009).
url: http://rsc.niaid.nih.gov/sites/default/files/manual-exped-aes-v2_0.pdf
description: Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010.
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis
mesh term: Ritonavir
mesh term: Ribavirin
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