Overview

Treatment of Chronic Hepatitis C With PEG Interferon alfa2a and Ribavirin in HIV-Infected Patients

Status:
Completed
Trial end date:
2004-06-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital, Bordeaux
Collaborators:
Hoffmann-La Roche
Ministry of Health, France
Treatments:
Interferon-alpha
Interferons
Peginterferon alfa-2a
Ribavirin
Criteria
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