<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/NCT01718301</url>
  </required_header>
  <id_info>
    <org_study_id>BOC-HIV</org_study_id>
    <secondary_id>2012-003984-23</secondary_id>
    <nct_id>NCT01718301</nct_id>
  </id_info>
  <brief_title>HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin</brief_title>
  <acronym>BOC-HIV</acronym>
  <official_title>A Study to Evaluate Safety and Efficacy of Boceprevir-response Guided Therapy in Controlled HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin Eudra CT2012-003984-23</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Anna Cruceta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundacion Clinic per a la Recerca Biomédica</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to evaluate the safety and efficacy of a Response&#xD;
      Guided Therapy of boceprevir 800 mg dosed three times a day (TID) orally (PO) in combination&#xD;
      with Peginterferon (either alpha 2b or alpha 2a) and Ribavirin in HIV/HCV genotype 1 infected&#xD;
      patients that failed to previous HCV therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>Phase 3</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>Achievement of sustained virological response (SVR) at week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>The primary efficacy endpoint is the achievement of SVR, defined as undetectable plasma HCV-RNA at Follow-up Week (FW) 24. If a subject is missing FW 24 data and has undetectable HCV-RNA level at FW 12, the subject would be considered an SVR.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Achievement of sustained virological response at weeks 2,4,8,12.</measure>
    <time_frame>Weeks 2, 4, 8, 12</time_frame>
    <description>The proportion of subjects with virological response (eg. undetectable HCV-RNA at Weeks 2, 4, 8, or 12) in subjects who achieve SVR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects with undetectable HCV-RNA at FW 12.</measure>
    <time_frame>Week 12</time_frame>
    <description>The proportion of subjects with undetectable HCV-RNA at FW 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects with undetectable HCV-RNA at 72 weeks after randomization.</measure>
    <time_frame>Week 72</time_frame>
    <description>The proportion of subjects with undetectable HCV-RNA at 72 weeks after randomization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>From baseline to study completion (up to 72 weeks)</time_frame>
    <description>Safety: number of adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resistance of HCV after boceprevir (BOC) containing regimen</measure>
    <time_frame>whenever resistance occurs during the study (from week 12 until the date the resistance occurs, assessed up to 72 weeks)</time_frame>
    <description>Resistance of HCV after boceprevir containing regimen. Blood samples will be collected at baseline and after HCV virological failure and resistance analysis will be done at the end of the study in a single Center (Hospital Clínic-Barcelona).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Hepatitis C</condition>
  <condition>HIV Infections</condition>
  <condition>COINFECTION</condition>
  <arm_group>
    <arm_group_label>boceprevir + ribavirin + peginterferon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>boceprevir 800 mg three times a day (v.o.) in combination with peginterferon (alfa-2b or alfa-2a) and ribavirin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>boceprevir</intervention_name>
    <arm_group_label>boceprevir + ribavirin + peginterferon</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavirin</intervention_name>
    <arm_group_label>boceprevir + ribavirin + peginterferon</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Peginterferon alfa-2a</intervention_name>
    <arm_group_label>boceprevir + ribavirin + peginterferon</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Peginterferon alfa-2b</intervention_name>
    <arm_group_label>boceprevir + ribavirin + peginterferon</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For inclusion in the study, subjects must have a qualifying regimen defined as&#xD;
             peginterferon alfa-2a plus ribavirin or peginterferon alfa-2b plus ribavirin for a&#xD;
             minimum of 12 weeks. If a subject has received more than one such regimen, the most&#xD;
             recent regimen is considered the qualifying regimen.&#xD;
&#xD;
          -  Subject must have previously documented chronic hepatitis C (CHC) genotype 1&#xD;
             infection. Subjects with other or mixed genotypes are not eligible. The HCV-RNA result&#xD;
             at the screening visit must confirm genotype 1 infection and be ≥10,000 IU/mL.&#xD;
&#xD;
          -  Subject must have a liver biopsy with histology consistent with CHC and no other&#xD;
             etiology and/or Fibroscan assessment. In case of:&#xD;
&#xD;
               1. No cirrhosis. Biopsies and/or Fibroscan must be within 18 months of screening&#xD;
                  visit.&#xD;
&#xD;
               2. Cirrhosis. No specific length of time would be requested.&#xD;
&#xD;
          -  All patients with cirrhosis must have an ultrasound 6 month within of screening visit.&#xD;
&#xD;
          -  Patients must be on stable antiretroviral therapy including a CD4 cell count of more&#xD;
             than 100 per mm3 and a HIV plasmatic viral load undetectable (it is &lt; 50 copies/mL)&#xD;
             for more than 6 months. Antiretroviral therapy must be Raltegravir-based (al least&#xD;
             during the last 3 months).&#xD;
&#xD;
          -  Subject must be ≥18 years of age.&#xD;
&#xD;
          -  HIV treatment should not contain efavirenz (EFV), nevirapine (NVP), etravirine (ETV),&#xD;
             didanosine (ddI), stavudine (d4T), zidovudine (AZT), or HIV protease inhibitors.&#xD;
&#xD;
          -  Subject must weight between 40 kg and 125 kg.&#xD;
&#xD;
          -  Subject and subject's partner(s) must each agree to use acceptable methods of&#xD;
             contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months&#xD;
             after last dose of study drug.&#xD;
&#xD;
          -  Subjects must be willing to give written informed consent and by investigator opinion&#xD;
             be able to follow the protocol visit design.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects known to be coinfected with hepatitis B virus (HBsAg positive).&#xD;
&#xD;
          -  Patients chronically infected with HCV genotype other than 1&#xD;
&#xD;
          -  CD4 cell count &lt; 100 cel/mm3.&#xD;
&#xD;
          -  Plasma HIV RNA more than 50 copies/mL&#xD;
&#xD;
          -  Platelet count less than 80.000 /mm3&#xD;
&#xD;
          -  Subjects who required discontinuation of previous interferon or ribavirin regimen for&#xD;
             a severe adverse event considered by the investigator to be possibly or probably&#xD;
             related to ribavirin and/or interferon.&#xD;
&#xD;
          -  Treatment with ribavirin within 90 days and any interferon-alpha within 1 month of&#xD;
             Screening.&#xD;
&#xD;
          -  Treatment for hepatitis C with any investigational medication. Prior treatments with&#xD;
             herbal remedies with known hepatotoxicity are exclusionary.&#xD;
&#xD;
          -  Participation in any other clinical trial within 30 days of randomization or intention&#xD;
             to participate in another clinical trial during participation in this study.&#xD;
&#xD;
          -  History of hemoglobinopathy (e.g., thalassemia) or any other cause of or tendency to&#xD;
             hemolysis.&#xD;
&#xD;
          -  Evidence of decompensate liver disease including, but not limited to, a history or&#xD;
             presence of clinical ascites, bleeding varices, or hepatic encephalopathy.&#xD;
&#xD;
          -  Diabetic and/or hypertensive subjects with clinically significant ocular examination&#xD;
             findings.&#xD;
&#xD;
          -  Unstable or untreated pre-existing psychiatric condition.&#xD;
&#xD;
          -  Any known pre-existing medical condition that could interfere with the subject's&#xD;
             participation in and completion of the study.&#xD;
&#xD;
          -  Any current evidence of substance abuse of alcohol or other drugs.&#xD;
&#xD;
          -  Subjects receiving opioid agonist substitution therapy but not enrolled in an opiate&#xD;
             substitution maintenance program.&#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>Josep Mallolas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clínic i Provincial de Barcelona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Clinic i Provincial de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>July 8, 2015</last_update_submitted>
  <last_update_submitted_qc>July 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Fundacion Clinic per a la Recerca Biomédica</investigator_affiliation>
    <investigator_full_name>Anna Cruceta</investigator_full_name>
    <investigator_title>Clinical Research manager</investigator_title>
  </responsible_party>
  <keyword>HCV</keyword>
  <keyword>HIV</keyword>
  <keyword>Coinfection</keyword>
  <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 C, Chronic</mesh_term>
    <mesh_term>Coinfection</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ribavirin</mesh_term>
    <mesh_term>Peginterferon alfa-2a</mesh_term>
    <mesh_term>Peginterferon alfa-2b</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>September 1, 2015</submitted>
    <returned>September 29, 2015</returned>
    <submitted>October 2, 2015</submitted>
    <returned>October 30, 2015</returned>
    <submitted>February 13, 2019</submitted>
    <returned>May 28, 2019</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01718301
org study id: BOC-HIV
secondary id: 2012-003984-23
nct id: NCT01718301
lead sponsor: 
has dmc: No
The primary objective of this study is to evaluate the safety and efficacy of a Response
      Guided Therapy of boceprevir 800 mg dosed three times a day (TID) orally (PO) in combination
      with Peginterferon (either alpha 2b or alpha 2a) and Ribavirin in HIV/HCV genotype 1 infected
      patients that failed to previous HCV therapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Achievement of sustained virological response (SVR) at week 24
time frame: Week 24
description: The primary efficacy endpoint is the achievement of SVR, defined as undetectable plasma HCV-RNA at Follow-up Week (FW) 24. If a subject is missing FW 24 data and has undetectable HCV-RNA level at FW 12, the subject would be considered an SVR.
measure: Achievement of sustained virological response at weeks 2,4,8,12.
time frame: Weeks 2, 4, 8, 12
description: The proportion of subjects with virological response (eg. undetectable HCV-RNA at Weeks 2, 4, 8, or 12) in subjects who achieve SVR.
measure: The proportion of subjects with undetectable HCV-RNA at FW 12.
time frame: Week 12
description: The proportion of subjects with undetectable HCV-RNA at FW 12.
measure: The proportion of subjects with undetectable HCV-RNA at 72 weeks after randomization.
time frame: Week 72
description: The proportion of subjects with undetectable HCV-RNA at 72 weeks after randomization.
measure: Number of adverse events
time frame: From baseline to study completion (up to 72 weeks)
description: Safety: number of adverse events
measure: Resistance of HCV after boceprevir (BOC) containing regimen
time frame: whenever resistance occurs during the study (from week 12 until the date the resistance occurs, assessed up to 72 weeks)
description: Resistance of HCV after boceprevir containing regimen. Blood samples will be collected at baseline and after HCV virological failure and resistance analysis will be done at the end of the study in a single Center (Hospital Clínic-Barcelona).
arm group label: boceprevir + ribavirin + peginterferon
arm group type: Experimental
description: boceprevir 800 mg three times a day (v.o.) in combination with peginterferon (alfa-2b or alfa-2a) and ribavirin
intervention type: Drug
intervention name: boceprevir
arm group label: boceprevir + ribavirin + peginterferon
intervention type: Drug
intervention name: Ribavirin
arm group label: boceprevir + ribavirin + peginterferon
intervention type: Drug
intervention name: Peginterferon alfa-2a
arm group label: boceprevir + ribavirin + peginterferon
intervention type: Drug
intervention name: Peginterferon alfa-2b
arm group label: boceprevir + ribavirin + peginterferon
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Josep Mallolas, MD
role: Principal Investigator
affiliation: Hospital Clínic i Provincial de Barcelona
facility: 
country: Spain
responsible party type: Sponsor-Investigator
investigator affiliation: Fundacion Clinic per a la Recerca Biomédica
investigator full name: Anna Cruceta
investigator title: Clinical Research manager
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Coinfection
mesh term: Hepatitis
mesh term: Ribavirin
mesh term: Peginterferon alfa-2a
mesh term: Peginterferon alfa-2b
submitted: September 1, 2015
returned: September 29, 2015
submitted: October 2, 2015
returned: October 30, 2015
submitted: February 13, 2019
returned: May 28, 2019