Safety and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects Co-Infected With Hepatitis C Virus (HCV) and HIV

A Phase 2a, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Who Have Chronic HCV-1/HIV-1 Co-Infection and Are Treatment-Naïve for Hepatitis C

The purpose of this study is to determine whether the combination of telaprevir, peginterferon alfa-2a, and ribavirin is safe and effective in treating hepatitis C virus (HCV) infection in subjects who are infected with both HCV and human immunodeficiency virus (HIV).

Inclusion Criteria:

• Chronic, genotype 1, hepatitis C with detectable HCV RNA
• HIV-1 infection for >6 months
• Documentation of a liver biopsy within 1 year before the screening visit showing evidence of hepatitis (demonstrated by inflammation and/or fibrosis)

Exclusion Criteria:

• Previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C
• Previous treatment with interferon or ribavirin
• Evidence of hepatic decompensation in cirrhotic subjects
• Subjects who have participated in a clinical study involving administration of an investigational drug within 2 months
• Part A only: subjects who have been on a HAART regimen within 12 weeks before study start