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

Phase 2

Completed

• Conditions: Hepatitis C; HIV Infections
• Interventions: Drug: telaprevir or matching placebo; Biological: peginterferon alfa-2a; Drug: ribavirin (fixed dose); Drug: ribavirin (weight-based dose)

• Registration Number: NCT00983853
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

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 who are infected with both HCV and human immunodeficiency virus (HIV).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-22
• Study First Submitted QC: 2009-09-23
• Study First Posted: 2009-09-24
• Study Start: 2009-10
• Primary Completion: 2012-03
• Status Verified: 2013-08
• Results First Submitted: 2013-08-02
• Results First Submitted QC: 2013-08-02
• Last Update Submitted: 2013-08-02
• Results First Posted: 2013-10-10
• Last Update Posted: 2013-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part A	ribavirin (fixed dose)	The dose of ribavirin used (fixed versus weight-based) is region dependent
Part B	ribavirin (weight-based dose)	The dose of ribavirin used (fixed versus weight-based) is region dependent
Part A	telaprevir or matching placebo	The dose of ribavirin used (fixed versus weight-based) is region dependent
Part A	peginterferon alfa-2a	The dose of ribavirin used (fixed versus weight-based) is region dependent
Part A	ribavirin (weight-based dose)	The dose of ribavirin used (fixed versus weight-based) is region dependent
Part B	telaprevir or matching placebo	The dose of ribavirin used (fixed versus weight-based) is region dependent
Part B	peginterferon alfa-2a	The dose of ribavirin used (fixed versus weight-based) is region dependent
Part B	ribavirin (fixed dose)	The dose of ribavirin used (fixed versus weight-based) is region dependent

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects Achieving Undetectable HCV RNA at Week 12	12 weeks after first dose of study drug

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects Achieving Undetectable HCV RNA at Week 4 and Week 12	4 and 12 weeks after the first dose of study drug	number of subjects with undetectable HCV RNA
Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks (SVR12) and 24 Weeks (SVR24) After Last Planned Dose of Study Treatment	12 weeks after last dose of study drug
Median Trough Plasma Concentration (Ctrough) Ratios of Efavirenz and Tenofovir (Part B Only, Subjects on EFV-based HAART)	through 12 weeks after first dose of study drug	Ctrough ratio of HAART medication with telaprevir (test) and without telaprevir (reference)
Median Trough Plasma Concentration (Ctrough) Ratios of Atazanavir (ATZ), Ritonavir, and Tenofovir (Part B Only, Subjects on ATV-based HAART)	through 12 weeks after first dose of study drug	Ctrough of HAART medication with telaprevir (test) and without telaprevir (reference)
Effect of Efavirenz-based (EFV) and Atazanavir-based (ATV/r) Highly Active Antiretroviral Therapy(HAART) on Telaprevir Exposure	through 12 weeks after first dose of study drug