Phase 2
N=62
Safety and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects Co-Infected With Hepatitis C Virus (HCV) and HIV
Hepatitis C · HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00983853 ↗Enrolled (actual)
62
Serious AEs
15.0%
Results posted
Oct 2013
Primary outcome: Primary: Proportion of Subjects Achieving Undetectable HCV RNA at Week 12 — 6; 2; 14; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- telaprevir or matching placebo (Drug); peginterferon alfa-2a (Biological); ribavirin (fixed dose) (Drug); ribavirin (weight-based dose) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vertex Pharmaceuticals Incorporated
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects Achieving Undetectable HCV RNA at Week 12 |
6; 2; 14; 2; 10; 2 | — |
| SECONDARY Proportion of Subjects Achieving Undetectable HCV RNA at Week 4 and Week 12 |
5; 0; 12; 0; 9; 0 | — |
| SECONDARY Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks (SVR12) and 24 Weeks (SVR24) After Last Planned Dose of Study Treatment |
5; 2; 11; 4; 12; 4 | — |
| SECONDARY Effect of Efavirenz-based (EFV) and Atazanavir-based (ATV/r) Highly Active Antiretroviral Therapy(HAART) on Telaprevir Exposure |
0.8842; 1.3059; 0.9610; 1.0930; 1.0061; 1.0075 | — |
| SECONDARY Median Trough Plasma Concentration (Ctrough) Ratios of Efavirenz and Tenofovir (Part B Only, Subjects on EFV-based HAART) |
0.94; 0.79; 1.06; 0.64 | — |
| SECONDARY Median Trough Plasma Concentration (Ctrough) Ratios of Atazanavir (ATZ), Ritonavir, and Tenofovir (Part B Only, Subjects on ATV-based HAART) |
1.16; 1.03; 0.75; 0.93; 0.72; 0.74 | — |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00983853). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.