Overview

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