HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin (BOC-HIV)

August 6, 2025 updated by: Anna Cruceta

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

In a total number of 108 patients the protocol was evaluated but only in 102 the protocol efectively was presented. In the remaining 6 patients we don't believe the trial could be performed.

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínic i Provincial de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • For inclusion in the study, subjects must have a qualifying regimen defined as peginterferon alfa-2a plus ribavirin or peginterferon alfa-2b plus ribavirin for a minimum of 12 weeks. If a subject has received more than one such regimen, the most recent regimen is considered the qualifying regimen.
  • Subject must have previously documented chronic hepatitis C (CHC) genotype 1 infection. Subjects with other or mixed genotypes are not eligible. The HCV-RNA result at the screening visit must confirm genotype 1 infection and be ≥10,000 IU/mL.

  • Subject must have a liver biopsy with histology consistent with CHC and no other etiology and/or Fibroscan assessment. In case of:

    1. No cirrhosis. Biopsies and/or Fibroscan must be within 18 months of screening visit.
    2. Cirrhosis. No specific length of time would be requested.
  • All patients with cirrhosis must have an ultrasound 6 month within of screening visit.
  • Patients must be on stable antiretroviral therapy including a CD4 cell count of more than 100 per mm3 and a HIV plasmatic viral load undetectable (it is < 50 copies/mL) for more than 6 months. Antiretroviral therapy must be Raltegravir-based (al least during the last 3 months).
  • Subject must be ≥18 years of age.
  • HIV treatment should not contain efavirenz (EFV), nevirapine (NVP), etravirine (ETV), didanosine (ddI), stavudine (d4T), zidovudine (AZT), or HIV protease inhibitors.
  • Subject must weight between 40 kg and 125 kg.
  • Subject and subject's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug.
  • Subjects must be willing to give written informed consent and by investigator opinion be able to follow the protocol visit design.

Exclusion Criteria:

  • Subjects known to be coinfected with hepatitis B virus (HBsAg positive).
  • Patients chronically infected with HCV genotype other than 1
  • CD4 cell count < 100 cel/mm3.
  • Plasma HIV RNA more than 50 copies/mL
  • Platelet count less than 80.000 /mm3
  • Subjects who required discontinuation of previous interferon or ribavirin regimen for a severe adverse event considered by the investigator to be possibly or probably related to ribavirin and/or interferon.
  • Treatment with ribavirin within 90 days and any interferon-alpha within 1 month of Screening.
  • Treatment for hepatitis C with any investigational medication. Prior treatments with herbal remedies with known hepatotoxicity are exclusionary.
  • Participation in any other clinical trial within 30 days of randomization or intention to participate in another clinical trial during participation in this study.
  • History of hemoglobinopathy (e.g., thalassemia) or any other cause of or tendency to hemolysis.
  • Evidence of decompensate liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
  • Diabetic and/or hypertensive subjects with clinically significant ocular examination findings.
  • Unstable or untreated pre-existing psychiatric condition.
  • Any known pre-existing medical condition that could interfere with the subject's participation in and completion of the study.
  • Any current evidence of substance abuse of alcohol or other drugs.
  • Subjects receiving opioid agonist substitution therapy but not enrolled in an opiate substitution maintenance program.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: boceprevir + ribavirin + peginterferon
boceprevir 800 mg three times a day (v.o.) in combination with peginterferon (alfa-2b or alfa-2a) and ribavirin
Drug: boceprevir
Drug: Ribavirin
Drug: Peginterferon alfa-2b
Drug: Peginterferon alfa-2a

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achievement of Sustained Virological Response (SVR) at 24 Weeks Post-Treatment
Time Frame: Week 24

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.
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achievement of Sustained Virological Response at Weeks 2,4,8,12.
Time Frame: Weeks 2, 4, 8, 12
Proportion of participants with undetectable HCV RNA (<15 IU/mL) at weeks 2, 4, 8, and 12 during treatment.
Weeks 2, 4, 8, 12
The Proportion of Subjects With Undetectable HCV-RNA at FW 12.
Time Frame: Week 12
The proportion of subjects with undetectable HCV-RNA at follow-up week 12.
Week 12
The Proportion of Subjects With Undetectable HCV-RNA at 72 Weeks After Randomization.
Time Frame: Week 72
The proportion of randomized subjects with undetectable HCV-RNA at 72 weeks after randomization.
Week 72
Number of Adverse Events
Time Frame: From baseline to study completion (up to 72 weeks)
Safety: number of adverse events
From baseline to study completion (up to 72 weeks)
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)
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).
whenever resistance occurs during the study (from week 12 until the date the resistance occurs, assessed up to 72 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anna Cruceta

Investigators

  • Principal Investigator: Josep Mallolas, MD, Hospital Clínic i Provincial de Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2013

Primary Completion (Actual)

March 20, 2015

Study Completion (Actual)

June 30, 2015

Study Registration Dates

First Submitted

October 25, 2012

First Submitted That Met QC Criteria

October 30, 2012

First Posted (Estimated)

October 31, 2012

Study Record Updates

Last Update Posted (Actual)

August 24, 2025

Last Update Submitted That Met QC Criteria

August 6, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BOC-HIV
  • 2012-003984-23 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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