Overview

Efficacy of Pegylated Interferon on Liver Fibrosis in Co-infected Patient With HIV and Hepatitis C

Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
0
Participant gender:
All
Summary
The aim of this study is to prove the efficacy of peginterferon in HIV infected patients with liver disease caused by hepatitis C virus (HCV) when the treatment to eradicate the virus failed. This scientific proof needs a comparative study to be done including two groups of patients randomly allocated: one with the treatment (peginterferon) and the other without any treatment against HCV with a duration of 2 years. To conclude, two liver biopsies are needed; one before the study and a second 2 years after.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborator:
Hoffmann-La Roche
Treatments:
Anti-Retroviral Agents
Interferon-alpha
Interferons
Peginterferon alfa-2a
Ribavirin
Criteria
Inclusion Criteria:

- HIV infection (Western Blot +)

- C hepatitis (RNA viral hepatitis C [VHC] +)

- Chronic active C hepatitis on liver histological score METAVIR (A over or equal to 1
and F over or equal to 2) on biopsy performed at least 18 months before the expected
date of inclusion

- Previous treatment for C hepatitis for at least 3 months including peg-interferon and
ribavirin or peg-interferon alone if counterindication for ribavirin occurred

- Failure to eradicate C hepatitis virus after well conducted treatment

- The liver biopsy should have been realised at least 18 months before inclusion :

Either before treatment for C hepatitis in patients treated at most 7 months Or at least 6
months after anti HCV treatment in patient treated for more than 7 months (wash out period)

- Regular follow up in an outpatient clinic for HIV

- Unchanged antiretroviral treatment the last 3 months before inclusion

- Inform consent

Exclusion Criteria:

- History of transplantation or clinical hepatic failure

- Opportunistic infection in the past three months before inclusion

- Any hepatic disease not related to HCV (B hepatitis, hemochromatosis, Wilson disease)

- Diabetes mellitus

- Immunocompromised treatment

- Active intravenous drug addiction

- Alcohol consumption of more than 50 g per day

- Counterindication for the use of interferon