Status:
COMPLETED
Safety and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects Co-Infected With Hepatitis C Virus (HCV) and HIV
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Collaborating Sponsors:
Tibotec Pharmaceutical Limited
Conditions:
Hepatitis C
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 wh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00983853
Start Date
October 1 2009
Last Update
October 10 2013
Active Locations (16)
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1
Beverly Hills, California, United States, 90211
2
San Diego, California, United States, 92093
3
San Francisco, California, United States, 94110
4
Miami, Florida, United States, 33125