NCT00983853

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hepatitis C
• HIV Infections

Interventions

Type	Name	Description
DRUG	telaprevir or matching placebo	Tablet, Oral, 750 mg, q8h, 12 weeks
DRUG	telaprevir or matching placebo	Tablet, Oral, 750 mg or 1125 mg, q8h, 12 weeks
BIOLOGICAL	peginterferon alfa-2a	Subcutaneous injection, 180 μg, once weekly, 48 weeks
DRUG	ribavirin (fixed dose)	Tablet, Oral, 800 mg, b.i.d., 48 weeks
DRUG	ribavirin (weight-based dose)	Tablet, Oral, 1000 mg for subjects weighing \<75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-03-01
• First posted: 2009-09-24
• Last updated: 2013-10-10
• Results posted: 2013-10-10

Locations

16 sites across 4 countries: United States, France, Germany, Spain