Treatment of Chronic Hepatitis C With PEG Interferon alfa2a and Ribavirin in HIV-infected Patients (ROCO2)

May 12, 2026 updated by: University Hospital, Bordeaux

Efficacy and Safety of Peginterferon alfa2a and Ribavirin for the Second Line Treatment of Chronic Hepatitis C in HIV Infected Patients Previously Non Responders to a First Anti-HCV Treatment

Combination of PEG interferon and ribavirin is the standard treatment of chronic hepatitis C. Efficacy of this treatment has never been evaluated in HCV-HIV infected patients, who have previously been treated with a first line anti-HCV treatment. The purpose of the study is to evaluate the combination PEG interferon alfa2a-ribavirin in HIV-infected patients with chronic hepatitis C pretreated with interferon alone or interferon combined with ribavirin. The patients receive a dose of 180 µg of PEGASYS once a week and 800 to 1200 mg/day of ribavirin (according to weight) for 48 weeks. Primary outcome of the study is a sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti-HCV treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

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

France
- - Bordeaux, France, 33076
    - Hôpital Pellegrin, Federation des Maladies Infectieuses, Pr RAGNAUD

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Chronic hepatitis C : Detectable HCV RNA, Previously treated with interferon or interferon combined with ribavirin, Elevated ALT level
HIV infection (CD4>250/µL, HIV RNA<10 000 copies/ml) treated or not with antiretroviral therapy
Signed informed consent

Exclusion Criteria:

Chronic hepatitis B
Alcohol consumption>40g/day
Evidence of decompensated liver disease
Hepatocellular carcinoma
Other relevant disorders: organ transplantation, psychiatric or cardiovascular disease, poorly controlled diabetes, seizure disorders, hemoglobinopathy, autoimmune disease

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: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with a sustained virological response, defined as an undetectable HCV RNA level Time Frame: 24 weeks after the end of anti-HCV treatment	24 weeks after the end of anti-HCV treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety of treatment
Proportion of patients with a virological response Time Frame: at weeks 24 and 48	at weeks 24 and 48
Influence of anti-HCV treatment on CD4 count and HIV RNA
Proportion of patients with histological response 24 weeks after the end of anti-HCV treatment

Collaborators and Investigators

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

Sponsor

University Hospital, Bordeaux

Collaborators

Hoffmann-La Roche

Ministry of Health, France

Investigators

Study Chair: Geneviève CHENE, Pr, University Hospital, Bordeaux
Principal Investigator: Didier Neau, MD-PhD, Hôpital Pellegrin, 33076 Bordeaux Cedex, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2002

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria