Efficacy and Safety of Peg-Interferon Alpha-2a Plus Ribavirin in Genotype 1 Chronic Hepatitis C Participants Co-Infected With Human Immunodeficiency Virus

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized, multi-center, Phase IV, comparative study will assess the efficacy and safety of combined peg-interferon alpha-2a (Peg-IFN-Alpha-2A) and ribavirin therapy for 48 or 72 weeks of treatment and 24 weeks of follow-up in participants with Genotype 1 chronic hepatitis C (CHC), co-infected with human immunodeficiency virus type 1 (HIV-1).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Serological evidence of chronic hepatitis C infection by anti-hepatitis C virus (HCV) test

• Detectable HCV-ribonucleic acid (RNA) plasma level testing by Roche AMPLICOR HCV (<50 International Units per milliliter [IU/mL]) (qualitative test)

• Chronic liver disease consistent with infection of CHC

• Compensated liver disease (Child-Pugh Grade A)

• Serological evidence of infection by HIV-1 test, anti-HIV-1 or HIV-1 RNA detection

• Negative pregnancy urine or blood test (for women in childbearing age); additionally, all men and women of childbearing potential must agree to use two effective forms of contraception during the treatment and during the 6 months after the end of treatment

Exclusion Criteria:

• Pregnant or nursing women and male partners of pregnant women

• Prior therapy with interferon (IFN) or ribavirin and any investigational medication less than or equal to (
• History or other evidence of a medical condition associated with chronic liver disease further than HCV

• Active opportunistic infection associated with HIV and / or cancer requiring systemic therapy

• History of any other significant illness which in the investigator's opinion, could result in the participant's inability to meet the Protocol requirements