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
- Conditions
- chronic hepatitis c virus genotype 1 infectionhuman immunodeficiency virus genotype 1 infectionMedDRA version: 12.1Level: LLTClassification code 10008912Term: Chronic hepatitis CMedDRA version: 12.1Level: LLTClassification code 10008919Term: Chronic HIV infection
- Registration Number
- EUCTR2008-007995-81-FR
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 68
- 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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): - Safety (AEs, physical examination findings, clinical laboratory results, and vital sign assessments) through Week 12 of dosing and through safety follow-up<br> - Plasma HCV RNA levels at Week 12 of dosing<br>;Main Objective: Part A and B<br> - Safety and tolerability of telaprevir, peginterferon alfa 2a (Peg IFN-alfa 2a or P), and ribavirin (RBV or R)<br> - Efficacy of telaprevir, Peg IFN-alfa 2a, and RBV at Week 12 of dosing<br>;Secondary Objective: Part A and B<br> - Pharmacokinetics of telaprevir, Peg IFN-alfa 2a, and RBV<br> - Efficacy of telaprevir, when used in combination with Peg IFN-alfa 2a and RBV<br> - Effect of telaprevir on the selection of resistant HCV variants<br><br>Part B only<br>Pharmacokinetics of pre-specified HAART medications
- Secondary Outcome Measures
Name Time Method