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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis C, HIV Infections

In brief

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).

Key facts

Study ID

NCT00983853

Run by

Vertex Pharmaceuticals Incorporated

People needed

62

Starts

2009-10-01

Last updated by the study team

2013-10-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — Beverly Hills, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — New York, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Dallas, Texas, United States
• Study site — Paris, France
• Study site — Bonn-Venusberg, Germany
• Study site — Hamburg, Germany
• Study site — Barcelona, Spain
• Study site — Madrid, Spain

Full record on ClinicalTrials.gov

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