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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Collaborator: Tibotec Pharmaceutical Limited
• Treatments: Interferon-alpha; Peginterferon alfa-2a; Ribavirin

Criteria

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