CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 62 enrolled
Drug / intervention
telaprevir or matching placebo +4 moredrug
Likely dose
telaprevir or matching placebo 750 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00983853
NCT00983853Phase 2Completed

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

Vertex Pharmaceuticals Incorporated·interventional·Posted Sep 24, 2009·Updated Oct 10, 2013

In Brief

A Phase 2 clinical trial evaluating telaprevir or matching placebo, peginterferon alfa-2a, and 2 other interventions for Hepatitis C and HIV Infections. Completed, enrolled 62 participants across 16 sites in 4 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Germany, Spain, United States

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 24, 2009
Enrollment StartOct 1, 2009
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 16.8 years ago

Interventions

telaprevir or matching placebodrug

Tablet, Oral, 750 mg, q8h, 12 weeks

telaprevir or matching placebodrug

Tablet, Oral, 750 mg or 1125 mg, q8h, 12 weeks

peginterferon alfa-2abiological

Subcutaneous injection, 180 μg, once weekly, 48 weeks

ribavirin (fixed dose)drug

Tablet, Oral, 800 mg, b.i.d., 48 weeks

ribavirin (weight-based dose)drug

Tablet, Oral, 1000 mg for subjects weighing \<75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks