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

Phase 2

Completed

• Conditions: HIV Infections; Treatment Failure; Hepatitis C, Chronic

• Registration Number: NCT00221650
• Lead Sponsor: University Hospital, Bordeaux

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Study Completion: 2004-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Status Verified: 2007-06
• Last Update Submitted: 2007-06-12
• Last Update Posted: 2007-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Pellegrin, Federation des Maladies Infectieuses, Pr RAGNAUD; 🇫🇷 Bordeaux, France