<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/NCT02247440</url>
  </required_header>
  <id_info>
    <org_study_id>PHPT-HCV</org_study_id>
    <nct_id>NCT02247440</nct_id>
  </id_info>
  <brief_title>HCV-HIV Co-infected Patient Cohort in Thailand</brief_title>
  <official_title>Response to Peg-interferon and Ribavirin for the Treatment of HCV Infection in HIV Co-infected Patients, Implemented in Public Hospitals in Thailand</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut de Recherche pour le Developpement</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Thailand</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut de Recherche pour le Developpement</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study of HCV treatment using the standard regimen of pegylated-interferon plus&#xD;
      ribavirin in HIV co-infected patients participating in the PHPT cohort study. The treatment&#xD;
      will be implemented in conjunction with gastro-enterologists/hepatologists by internists&#xD;
      responsible for the participant's HIV treatment.&#xD;
&#xD;
      Chronic hepatitis C virus (HCV) infection is responsible for several severe and life&#xD;
      threatening complications, which are worsened by HIV co-infection. HIV-HCV co-infected&#xD;
      patients are at a higher risk of death compared to HIV mono-infected individuals, even if HIV&#xD;
      replication is suppressed on antiretroviral treatment.&#xD;
&#xD;
      The goal of HCV antiviral treatment is to cure HCV infection. Curing HCV infection allows&#xD;
      fibrosis regression, improved clinical outcomes. In addition, individuals who have been cured&#xD;
      are no longer contagious to other individuals, therefore widespread access to HCV treatment&#xD;
      may contribute to the control of the HCV epidemic.&#xD;
&#xD;
      A combination of injectable pegylated-interferon with oral ribavirin is currently the&#xD;
      recommended regimen for the treatment of hepatitis C in the setting of HIV co-infection. They&#xD;
      are administered for 24 weeks in HCV mono-infected patients but need to be administered for&#xD;
      one year in HIV-HCV co-infected patients. Newer drugs, such as the first generation HCV&#xD;
      protease inhibitors (boceprevir, telaprevir), administered concomitantly, are used in&#xD;
      patients who have not been cured using peg-interferon + ribavirin, and may allow for shorter&#xD;
      treatment.&#xD;
&#xD;
      PRIMARY OBJECTIVE&#xD;
&#xD;
      1. To determine the percentage of patients according to genotypes with sustained virological&#xD;
      response 6 months after treatment discontinuation (SVR).&#xD;
&#xD;
      HCV TREATMENT&#xD;
&#xD;
        -  Peg-interferon alpha 2-b (a subcutaneous injection of 1.5 micrograms/kg once a week)&#xD;
&#xD;
        -  Ribavirin dosing according to HCV genotype and body weight; dose adjustment in case of&#xD;
           anemia.&#xD;
&#xD;
      A total of 60 patients could be enrolled in the study: 15 HCV-HIV co-infected patients in a&#xD;
      first part (starting in August 2014) and 45 patients in a second part, depending on funding.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Population Screening: HIV infected patients with a positive anti-HCV test will be&#xD;
      approached for screening if they are at least 18 years old, participate in the PHPT cohort&#xD;
      study, have evidence of control of HIV replication and have a CD4 cell count ≥200 cells/mm3&#xD;
      if currently receiving antiretroviral HIV treatment (on the same anti-HIV regimen for at&#xD;
      least 12 weeks); or HIV RNA load ≤5000 copies/ml CD4 cells ≥500 cells/mm3if not receiving&#xD;
      antiretroviral treatment.&#xD;
&#xD;
      Inclusion Criteria&#xD;
&#xD;
        -  Evidence of chronic HCV infection for at least 6 months before study entry (at least one&#xD;
           detectable HCV viral load, i.e. ≥17 IU/mL, with an antibody test positive at least 6&#xD;
           months before the HCV RNA load result)&#xD;
&#xD;
        -  Fibrosis Stage F2-3-4 determined by transient elastography (Fibroscan or other similar&#xD;
           equipment). During the first part of the study, priority will be given to patients with&#xD;
           Fibrosis Stage F2-3.&#xD;
&#xD;
        -  Negative pregnancy test (on the day of inclusion). Main exclusion criteria&#xD;
&#xD;
        -  Anemia and thrombocytopenia&#xD;
&#xD;
        -  Severe liver damage, advanced stage cirrhosis or cancer&#xD;
&#xD;
        -  Uncontrolled diabetes, Uncontrolled thyroid dysfunction&#xD;
&#xD;
        -  Retinopathy&#xD;
&#xD;
        -  Creatinine clearance &lt;50 mL/min (Cockcroft)&#xD;
&#xD;
        -  Disease associated with the immune system&#xD;
&#xD;
        -  Significant heart problems&#xD;
&#xD;
        -  Severe neuropsychiatric conditions&#xD;
&#xD;
        -  Contra-indication to study treatment (including pregnancy or lack of effective&#xD;
           contraception in the participant or female partner)&#xD;
&#xD;
        -  Other exclusion criteria related to the use of ribavirin and peg-interferon&#xD;
&#xD;
        -  Any conditions that, in the investigator's judgment, may compromise the follow up.&#xD;
&#xD;
      Follow up After HCV treatment initiation, patients will be monitored for safety and antiviral&#xD;
      efficacy at 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 weeks (end of treatment) and 6&#xD;
      months after treatment discontinuation.&#xD;
&#xD;
      Treatment will be discontinued earlier in patients who do not achieve early viral response,&#xD;
      i.e. a decrease of at least 2 log10 HCV RNA IU/mL after the first 12 weeks of HCV therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Sustained Virological Response 6 Months After Treatment Discontinuation</measure>
    <time_frame>6 months after end of treatment, i.e. 1.5 years after treatment initiation</time_frame>
    <description>Number of Participants with Sustained Virological Response 6 Months After Treatment Discontinuation,</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With at Least a Serious Adverse Events Associated With Study Treatment (Peg-interferon and Ribavirin)</measure>
    <time_frame>From initiation of treatment to 6 months after treatment discontinuation</time_frame>
    <description>Number of participants with at least a serious adverse events associated with study treatment (peg-interferon and ribavirin).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Grouped by HIV-1 RNA Concentrations</measure>
    <time_frame>At time of treatment discontinuation (whatever its date) and 6 months thereafter</time_frame>
    <description>Number of participants grouped by HIV-1 RNA concentrations (Detected vs. Not Detected).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants Completed the First 24 and 48 Weeks of Treatment</measure>
    <time_frame>From initiation of treatment to the first 48 weeks of treatment</time_frame>
    <description>Number of participants completed the first 24 and 48 weeks of treatment.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Adverse Events by Severity Grade</measure>
    <time_frame>From initiation of treatment to 6 months after treatment discontinuation</time_frame>
    <description>Number of adverse events (AE) by severity grade. The severity grading scale is based on the DAIDS grading table, the grading scale ranging from grades 1 to 5: Grade 1 indicates a mild event, Grade 2 indicates a moderate event, Grade 3 indicates a severe event, Grade 4 indicates a potentially life-threatening event, and Grade 5 indicates death.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants Able to Perform Self-injections of Peg-interferon</measure>
    <time_frame>From initiation of treatment to the first 48 weeks of treatment</time_frame>
    <description>Number of participants able to perform self-injections of peg-interferon.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and &lt; 80%</measure>
    <time_frame>From initiation of treatment to the first 48 weeks of treatment</time_frame>
    <description>Number of participants with ribavirin compliance at ≥ 95%, 80% - 95%, and &lt; 80%.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Hepatitis C Infection</condition>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>PegINF-ribavirin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week&#xD;
Ribavirin initial dosing in the morning and in the evening:&#xD;
For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).&#xD;
For genotypes 1, 4, 5 and 6:&#xD;
800 mg/day, if bodyweight &lt;65 kg,&#xD;
1000 mg/day, if bodyweight between 66-80 kg,&#xD;
1200 mg/day, if bodyweight between 81-105 kg,&#xD;
1400 mg/day, if bodyweight &gt;105 kg.&#xD;
Duration: 48 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Peg-interferon + ribavirin under HIV physician supervision</intervention_name>
    <description>Peg-interferon + ribavirin under HIV physician supervision</description>
    <arm_group_label>PegINF-ribavirin</arm_group_label>
    <other_name>Pegintron, Rebetol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Evidence of chronic HCV infection for at least 6 months before study entry (at least&#xD;
             one detectable HCV viral load, i.e. ≥17 IU/mL, with an antibody test positive at least&#xD;
             6 months before the HCV RNA load result)&#xD;
&#xD;
          -  Fibrosis Stage F2-3-4 determined by transient elastography (Fibroscan or other similar&#xD;
             equipment). During the first part of the study, priority will be given to patients&#xD;
             with Fibrosis Stage F2-3.&#xD;
&#xD;
          -  Negative pregnancy test (on the day of inclusion).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anemia and thrombocytopenia&#xD;
&#xD;
          -  Severe liver damage, advanced stage cirrhosis or cancer&#xD;
&#xD;
          -  Uncontrolled diabetes, Uncontrolled thyroid dysfunction&#xD;
&#xD;
          -  Retinopathy&#xD;
&#xD;
          -  Creatinine clearance &lt;50 mL/min (Cockcroft)&#xD;
&#xD;
          -  Disease associated with the immune system&#xD;
&#xD;
          -  Significant heart problems&#xD;
&#xD;
          -  Severe neuropsychiatric conditions Contra-indication to study treatment (including&#xD;
             pregnancy or lack of effective contraception in the participant or female partner)&#xD;
&#xD;
          -  Other exclusion criteria related to the use of ribavirin and peg-interferon&#xD;
&#xD;
          -  Any conditions that, in the investigator's judgment, may compromise the follow up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gonzague Jourdain, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut de Recherche pour le Developpement</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sanpatong Hospital</name>
      <address>
        <city>San Pa Tong</city>
        <state>Chiang Mai</state>
        <zip>50120</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nakornping Hospital</name>
      <address>
        <city>Chiang Mai</city>
        <zip>50180</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiangrai Prachanukroh Hospital</name>
      <address>
        <city>Chiang Rai</city>
        <zip>57000</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chonburi Hospital</name>
      <address>
        <city>Chon Buri</city>
        <zip>20000</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samutsakhon Hospital</name>
      <address>
        <city>Samut Sakhon</city>
        <zip>74000</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>March 16, 2018</results_first_submitted>
  <results_first_submitted_qc>February 22, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 3, 2019</results_first_posted>
  <last_update_submitted>February 22, 2019</last_update_submitted>
  <last_update_submitted_qc>February 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institut de Recherche pour le Developpement</investigator_affiliation>
    <investigator_full_name>GONZAGUE JOURDAIN</investigator_full_name>
    <investigator_title>Researcher</investigator_title>
  </responsible_party>
  <keyword>HCV</keyword>
  <keyword>HIV</keyword>
  <keyword>Thailand</keyword>
  <keyword>pegylated interferon</keyword>
  <keyword>ribavirin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Interferons</mesh_term>
    <mesh_term>Ribavirin</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 17, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT02247440/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>PegINF-ribavirin</title>
          <description>Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week&#xD;
Ribavirin initial dosing in the morning and in the evening:&#xD;
For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).&#xD;
For genotypes 1, 4, 5 and 6:&#xD;
800 mg/day, if bodyweight &lt;65 kg,&#xD;
1000 mg/day, if bodyweight between 66-80 kg,&#xD;
1200 mg/day, if bodyweight between 81-105 kg,&#xD;
1400 mg/day, if bodyweight &gt;105 kg.&#xD;
Duration: 48 weeks&#xD;
Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>PegINF-ribavirin</title>
          <description>Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week&#xD;
Ribavirin initial dosing in the morning and in the evening:&#xD;
For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).&#xD;
For genotypes 1, 4, 5 and 6:&#xD;
800 mg/day, if bodyweight &lt;65 kg,&#xD;
1000 mg/day, if bodyweight between 66-80 kg,&#xD;
1200 mg/day, if bodyweight between 81-105 kg,&#xD;
1400 mg/day, if bodyweight &gt;105 kg.&#xD;
Duration: 48 weeks&#xD;
Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
          </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.2" lower_limit="39.6" upper_limit="51.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Thailand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.8" lower_limit="20.6" upper_limit="25.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV RNA</title>
          <units>log10 IU/mL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.83" lower_limit="5.59" upper_limit="6.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV genotypes</title>
          <description>Response to and duration of peg-interferon treatment vary according to Hepatitis C virus (HCV) genotypes. Prior to initiating HCV treatment, HCV genotype was determined using the INNO-LiPA technique.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Gt 1a</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gt 1b</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gt 3a</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gt 3b</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gt 6a/b</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gt 6c-l</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>IL 28B polymorphism</title>
          <description>Single nucleotide polymorphisms (SNP) on IL-28B in particular at position called rs12979860, are associated with different responses to peg-interferon+ribavirin treatment. For example the rs12979860 CC is predictive of good response to treatment. This SNP was assessed in all participants at baseline using SNP real-time PCR assay.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>CC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Liver fibrosis stage</title>
          <description>Assessment of Liver fibrosis stages is needed to decide the HCV treatment.&#xD;
Liver Fibrosis stage was assessed by transient elastography ultrasound based technique that measured the stiffness of the liver. There are five stages starting from F0 no scarring until F4: cirrhosis or advanced scarring and treatment in this study was initiated in participants with F2-F4 fibrosis stages. Response to treatment was expected to be better in participants with lower fibrosis stages.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>F2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>F3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>F4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Sustained Virological Response 6 Months After Treatment Discontinuation</title>
        <description>Number of Participants with Sustained Virological Response 6 Months After Treatment Discontinuation,</description>
        <time_frame>6 months after end of treatment, i.e. 1.5 years after treatment initiation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PegINF-ribavirin</title>
            <description>Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week&#xD;
Ribavirin initial dosing in the morning and in the evening:&#xD;
For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).&#xD;
For genotypes 1, 4, 5 and 6:&#xD;
800 mg/day, if bodyweight &lt;65 kg,&#xD;
1000 mg/day, if bodyweight between 66-80 kg,&#xD;
1200 mg/day, if bodyweight between 81-105 kg,&#xD;
1400 mg/day, if bodyweight &gt;105 kg.&#xD;
Duration: 48 weeks&#xD;
Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Sustained Virological Response 6 Months After Treatment Discontinuation</title>
          <description>Number of Participants with Sustained Virological Response 6 Months After Treatment Discontinuation,</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With at Least a Serious Adverse Events Associated With Study Treatment (Peg-interferon and Ribavirin)</title>
        <description>Number of participants with at least a serious adverse events associated with study treatment (peg-interferon and ribavirin).</description>
        <time_frame>From initiation of treatment to 6 months after treatment discontinuation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PegINF-ribavirin</title>
            <description>Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week&#xD;
Ribavirin initial dosing in the morning and in the evening:&#xD;
For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).&#xD;
For genotypes 1, 4, 5 and 6:&#xD;
800 mg/day, if bodyweight &lt;65 kg,&#xD;
1000 mg/day, if bodyweight between 66-80 kg,&#xD;
1200 mg/day, if bodyweight between 81-105 kg,&#xD;
1400 mg/day, if bodyweight &gt;105 kg.&#xD;
Duration: 48 weeks&#xD;
Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least a Serious Adverse Events Associated With Study Treatment (Peg-interferon and Ribavirin)</title>
          <description>Number of participants with at least a serious adverse events associated with study treatment (peg-interferon and ribavirin).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Grouped by HIV-1 RNA Concentrations</title>
        <description>Number of participants grouped by HIV-1 RNA concentrations (Detected vs. Not Detected).</description>
        <time_frame>At time of treatment discontinuation (whatever its date) and 6 months thereafter</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PegINF-ribavirin</title>
            <description>Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week&#xD;
Ribavirin initial dosing in the morning and in the evening:&#xD;
For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).&#xD;
For genotypes 1, 4, 5 and 6:&#xD;
800 mg/day, if bodyweight &lt;65 kg,&#xD;
1000 mg/day, if bodyweight between 66-80 kg,&#xD;
1200 mg/day, if bodyweight between 81-105 kg,&#xD;
1400 mg/day, if bodyweight &gt;105 kg.&#xD;
Duration: 48 weeks&#xD;
Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Grouped by HIV-1 RNA Concentrations</title>
          <description>Number of participants grouped by HIV-1 RNA concentrations (Detected vs. Not Detected).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HIV-1 RNA not detected</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HIV-1 RNA detected</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants Completed the First 24 and 48 Weeks of Treatment</title>
        <description>Number of participants completed the first 24 and 48 weeks of treatment.</description>
        <time_frame>From initiation of treatment to the first 48 weeks of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PegINF-ribavirin</title>
            <description>Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week&#xD;
Ribavirin initial dosing in the morning and in the evening:&#xD;
For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).&#xD;
For genotypes 1, 4, 5 and 6:&#xD;
800 mg/day, if bodyweight &lt;65 kg,&#xD;
1000 mg/day, if bodyweight between 66-80 kg,&#xD;
1200 mg/day, if bodyweight between 81-105 kg,&#xD;
1400 mg/day, if bodyweight &gt;105 kg.&#xD;
Duration: 48 weeks&#xD;
Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Completed the First 24 and 48 Weeks of Treatment</title>
          <description>Number of participants completed the first 24 and 48 weeks of treatment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Completed the first 24 weeks of treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Completed the first 48 weeks of treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Adverse Events by Severity Grade</title>
        <description>Number of adverse events (AE) by severity grade. The severity grading scale is based on the DAIDS grading table, the grading scale ranging from grades 1 to 5: Grade 1 indicates a mild event, Grade 2 indicates a moderate event, Grade 3 indicates a severe event, Grade 4 indicates a potentially life-threatening event, and Grade 5 indicates death.</description>
        <time_frame>From initiation of treatment to 6 months after treatment discontinuation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PegINF-ribavirin</title>
            <description>Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week&#xD;
Ribavirin initial dosing in the morning and in the evening:&#xD;
For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).&#xD;
For genotypes 1, 4, 5 and 6:&#xD;
800 mg/day, if bodyweight &lt;65 kg,&#xD;
1000 mg/day, if bodyweight between 66-80 kg,&#xD;
1200 mg/day, if bodyweight between 81-105 kg,&#xD;
1400 mg/day, if bodyweight &gt;105 kg.&#xD;
Duration: 48 weeks&#xD;
Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Adverse Events by Severity Grade</title>
          <description>Number of adverse events (AE) by severity grade. The severity grading scale is based on the DAIDS grading table, the grading scale ranging from grades 1 to 5: Grade 1 indicates a mild event, Grade 2 indicates a moderate event, Grade 3 indicates a severe event, Grade 4 indicates a potentially life-threatening event, and Grade 5 indicates death.</description>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AE grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AE grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AE grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants Able to Perform Self-injections of Peg-interferon</title>
        <description>Number of participants able to perform self-injections of peg-interferon.</description>
        <time_frame>From initiation of treatment to the first 48 weeks of treatment</time_frame>
        <population>subject discontinued treatment after week 1&#xD;
subjects discontinued treatment after week 12&#xD;
1 subject discontinued treatment after week 24</population>
        <group_list>
          <group group_id="O1">
            <title>PegINF-ribavirin</title>
            <description>Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week&#xD;
Ribavirin initial dosing in the morning and in the evening:&#xD;
For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).&#xD;
For genotypes 1, 4, 5 and 6:&#xD;
800 mg/day, if bodyweight &lt;65 kg,&#xD;
1000 mg/day, if bodyweight between 66-80 kg,&#xD;
1200 mg/day, if bodyweight between 81-105 kg,&#xD;
1400 mg/day, if bodyweight &gt;105 kg.&#xD;
Duration: 48 weeks&#xD;
Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Able to Perform Self-injections of Peg-interferon</title>
          <description>Number of participants able to perform self-injections of peg-interferon.</description>
          <population>subject discontinued treatment after week 1&#xD;
subjects discontinued treatment after week 12&#xD;
1 subject discontinued treatment after week 24</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="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0 to Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>PegINF injected</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>PegINF not injected</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 to Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>PegINF injected</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>PegINF not injected</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 to Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>PegINF injected</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>PegINF not injected</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28 to Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>PegINF injected</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>PegINF not injected</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32 to Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>PegINF injected</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>PegINF not injected</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and &lt; 80%</title>
        <description>Number of participants with ribavirin compliance at ≥ 95%, 80% - 95%, and &lt; 80%.</description>
        <time_frame>From initiation of treatment to the first 48 weeks of treatment</time_frame>
        <population>subject discontinued treatment after week 1&#xD;
subjects discontinued treatment after week 12&#xD;
1 subject discontinued treatment after week 24</population>
        <group_list>
          <group group_id="O1">
            <title>PegINF-ribavirin</title>
            <description>Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week&#xD;
Ribavirin initial dosing in the morning and in the evening:&#xD;
For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).&#xD;
For genotypes 1, 4, 5 and 6:&#xD;
800 mg/day, if bodyweight &lt;65 kg,&#xD;
1000 mg/day, if bodyweight between 66-80 kg,&#xD;
1200 mg/day, if bodyweight between 81-105 kg,&#xD;
1400 mg/day, if bodyweight &gt;105 kg.&#xD;
Duration: 48 weeks&#xD;
Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and &lt; 80%</title>
          <description>Number of participants with ribavirin compliance at ≥ 95%, 80% - 95%, and &lt; 80%.</description>
          <population>subject discontinued treatment after week 1&#xD;
subjects discontinued treatment after week 12&#xD;
1 subject discontinued treatment after week 24</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="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0 to Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Compliance &lt; 80%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Compliance 80% - 95%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Compliance ≥ 95%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 to Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Compliance &lt; 80%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Compliance 80% - 95%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Compliance ≥ 95%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 to Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Compliance &lt; 80%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Compliance 80% - 95%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Compliance ≥ 95%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 to Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Compliance &lt; 80%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Compliance 80% - 95%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Compliance ≥ 95%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 to Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Compliance &lt; 80%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Compliance 80% - 95%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Compliance ≥ 95%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20 to Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Compliance &lt; 80%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Compliance 80% - 95%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Compliance ≥ 95%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 to Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Compliance &lt; 80%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Compliance 80% - 95%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Compliance ≥ 95%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28 to Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Compliance &lt; 80%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Compliance 80% - 95%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Compliance ≥ 95%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32 to Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Compliance &lt; 80%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Compliance 80% - 95%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Compliance ≥ 95%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 to Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Compliance &lt; 80%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Compliance 80% - 95%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Compliance ≥ 95%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44 to Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Compliance &lt; 80%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Compliance 80% - 95%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Compliance ≥ 95%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From enrollment until 6 months after treatment discontinuation</time_frame>
      <group_list>
        <group group_id="E1">
          <title>PegINF-ribavirin</title>
          <description>Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week&#xD;
Ribavirin initial dosing in the morning and in the evening:&#xD;
For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).&#xD;
For genotypes 1, 4, 5 and 6:&#xD;
800 mg/day, if bodyweight &lt;65 kg,&#xD;
1000 mg/day, if bodyweight between 66-80 kg,&#xD;
1200 mg/day, if bodyweight between 81-105 kg,&#xD;
1400 mg/day, if bodyweight &gt;105 kg.&#xD;
Duration: 48 weeks&#xD;
Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-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="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-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="13" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="30" subjects_affected="10" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="14" subjects_affected="8" subjects_at_risk="18"/>
              </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>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Gonzague Jourdain</name_or_title>
      <organization>Institut de Recherche pour le Developpement</organization>
      <phone>+66818830065</phone>
      <email>Gonzague.Jourdain@ird.fr</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/NCT02247440
org study id: PHPT-HCV
nct id: NCT02247440
lead sponsor: 
collaborator: 
has dmc: No
This is a study of HCV treatment using the standard regimen of pegylated-interferon plus
      ribavirin in HIV co-infected patients participating in the PHPT cohort study. The treatment
      will be implemented in conjunction with gastro-enterologists/hepatologists by internists
      responsible for the participant's HIV treatment.

      Chronic hepatitis C virus (HCV) infection is responsible for several severe and life
      threatening complications, which are worsened by HIV co-infection. HIV-HCV co-infected
      patients are at a higher risk of death compared to HIV mono-infected individuals, even if HIV
      replication is suppressed on antiretroviral treatment.

      The goal of HCV antiviral treatment is to cure HCV infection. Curing HCV infection allows
      fibrosis regression, improved clinical outcomes. In addition, individuals who have been cured
      are no longer contagious to other individuals, therefore widespread access to HCV treatment
      may contribute to the control of the HCV epidemic.

      A combination of injectable pegylated-interferon with oral ribavirin is currently the
      recommended regimen for the treatment of hepatitis C in the setting of HIV co-infection. They
      are administered for 24 weeks in HCV mono-infected patients but need to be administered for
      one year in HIV-HCV co-infected patients. Newer drugs, such as the first generation HCV
      protease inhibitors (boceprevir, telaprevir), administered concomitantly, are used in
      patients who have not been cured using peg-interferon + ribavirin, and may allow for shorter
      treatment.

      PRIMARY OBJECTIVE

      1. To determine the percentage of patients according to genotypes with sustained virological
      response 6 months after treatment discontinuation (SVR).

      HCV TREATMENT

        -  Peg-interferon alpha 2-b (a subcutaneous injection of 1.5 micrograms/kg once a week)

        -  Ribavirin dosing according to HCV genotype and body weight; dose adjustment in case of
           anemia.

      A total of 60 patients could be enrolled in the study: 15 HCV-HIV co-infected patients in a
      first part (starting in August 2014) and 45 patients in a second part, depending on funding.
Study Population Screening: HIV infected patients with a positive anti-HCV test will be
      approached for screening if they are at least 18 years old, participate in the PHPT cohort
      study, have evidence of control of HIV replication and have a CD4 cell count ≥200 cells/mm3
      if currently receiving antiretroviral HIV treatment (on the same anti-HIV regimen for at
      least 12 weeks); or HIV RNA load ≤5000 copies/ml CD4 cells ≥500 cells/mm3if not receiving
      antiretroviral treatment.

      Inclusion Criteria

        -  Evidence of chronic HCV infection for at least 6 months before study entry (at least one
           detectable HCV viral load, i.e. ≥17 IU/mL, with an antibody test positive at least 6
           months before the HCV RNA load result)

        -  Fibrosis Stage F2-3-4 determined by transient elastography (Fibroscan or other similar
           equipment). During the first part of the study, priority will be given to patients with
           Fibrosis Stage F2-3.

        -  Negative pregnancy test (on the day of inclusion). Main exclusion criteria

        -  Anemia and thrombocytopenia

        -  Severe liver damage, advanced stage cirrhosis or cancer

        -  Uncontrolled diabetes, Uncontrolled thyroid dysfunction

        -  Retinopathy

        -  Creatinine clearance <50 mL/min (Cockcroft)

        -  Disease associated with the immune system

        -  Significant heart problems

        -  Severe neuropsychiatric conditions

        -  Contra-indication to study treatment (including pregnancy or lack of effective
           contraception in the participant or female partner)

        -  Other exclusion criteria related to the use of ribavirin and peg-interferon

        -  Any conditions that, in the investigator's judgment, may compromise the follow up.

      Follow up After HCV treatment initiation, patients will be monitored for safety and antiviral
      efficacy at 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 weeks (end of treatment) and 6
      months after treatment discontinuation.

      Treatment will be discontinued earlier in patients who do not achieve early viral response,
      i.e. a decrease of at least 2 log10 HCV RNA IU/mL after the first 12 weeks of HCV therapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Sustained Virological Response 6 Months After Treatment Discontinuation
time frame: 6 months after end of treatment, i.e. 1.5 years after treatment initiation
description: Number of Participants with Sustained Virological Response 6 Months After Treatment Discontinuation,
measure: Number of Participants With at Least a Serious Adverse Events Associated With Study Treatment (Peg-interferon and Ribavirin)
time frame: From initiation of treatment to 6 months after treatment discontinuation
description: Number of participants with at least a serious adverse events associated with study treatment (peg-interferon and ribavirin).
measure: Number of Participants Grouped by HIV-1 RNA Concentrations
time frame: At time of treatment discontinuation (whatever its date) and 6 months thereafter
description: Number of participants grouped by HIV-1 RNA concentrations (Detected vs. Not Detected).
measure: Number of Participants Completed the First 24 and 48 Weeks of Treatment
time frame: From initiation of treatment to the first 48 weeks of treatment
description: Number of participants completed the first 24 and 48 weeks of treatment.
measure: Number of Adverse Events by Severity Grade
time frame: From initiation of treatment to 6 months after treatment discontinuation
description: Number of adverse events (AE) by severity grade. The severity grading scale is based on the DAIDS grading table, the grading scale ranging from grades 1 to 5: Grade 1 indicates a mild event, Grade 2 indicates a moderate event, Grade 3 indicates a severe event, Grade 4 indicates a potentially life-threatening event, and Grade 5 indicates death.
measure: Number of Participants Able to Perform Self-injections of Peg-interferon
time frame: From initiation of treatment to the first 48 weeks of treatment
description: Number of participants able to perform self-injections of peg-interferon.
measure: Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
time frame: From initiation of treatment to the first 48 weeks of treatment
description: Number of participants with ribavirin compliance at ≥ 95%, 80% - 95%, and < 80%.
arm group label: PegINF-ribavirin
arm group type: Experimental
description: Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week
Ribavirin initial dosing in the morning and in the evening:
For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).
For genotypes 1, 4, 5 and 6:
800 mg/day, if bodyweight <65 kg,
1000 mg/day, if bodyweight between 66-80 kg,
1200 mg/day, if bodyweight between 81-105 kg,
1400 mg/day, if bodyweight >105 kg.
Duration: 48 weeks
intervention type: Drug
intervention name: Peg-interferon + ribavirin under HIV physician supervision
description: Peg-interferon + ribavirin under HIV physician supervision
arm group label: PegINF-ribavirin
other name: Pegintron, Rebetol
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gonzague Jourdain, MD, PhD
role: Principal Investigator
affiliation: Institut de Recherche pour le Developpement
facility: 
facility: 
facility: 
facility: 
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Institut de Recherche pour le Developpement
investigator full name: GONZAGUE JOURDAIN
investigator title: Researcher
mesh term: Infections
mesh term: Hepatitis C
mesh term: Interferons
mesh term: Ribavirin
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 