Status:
COMPLETED
Efficacy of Pegylated Interferon on Liver Fibrosis in Co-infected Patient With HIV and Hepatitis C
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
HIV Infections
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 sci...
Detailed Description
C hepatitis in HIV infected patient becomes a major issue although the survival of patients, has improved in the last decades regarding to the advent of HAART, the mortality related to liver disease h...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00122616
Start Date
November 1 2003
End Date
March 1 2009
Last Update
February 22 2012
Active Locations (1)
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1
Service de Maladies Infectieuses et de Réanimation Médicale
Rennes, France, 35033