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

Study Overview
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Brief Summary
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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).

Official Title
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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
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Hepatitis C, HIV Infections

Intervention / Treatment
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* Drug: telaprevir or matching placebo
* Drug: telaprevir or matching placebo
* Biological: peginterferon alfa-2a
* Drug: ribavirin (fixed dose)
* Drug: ribavirin (weight-based dose)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A<br>The dose of ribavirin used (fixed versus weight-based) is region dependent | Drug: telaprevir or matching placebo<br>* Tablet, Oral, 750 mg, q8h, 12 weeks<br>Biological: peginterferon alfa-2a<br>* Subcutaneous injection, 180 μg, once weekly, 48 weeks<br>Drug: ribavirin (fixed dose)<br>* Tablet, Oral, 800 mg, b.i.d., 48 weeks<br>Drug: ribavirin (weight-based dose)<br>* Tablet, Oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks<br>|
| Experimental: Part B<br>The dose of ribavirin used (fixed versus weight-based) is region dependent | Drug: telaprevir or matching placebo<br>* Tablet, Oral, 750 mg or 1125 mg, q8h, 12 weeks<br>Biological: peginterferon alfa-2a<br>* Subcutaneous injection, 180 μg, once weekly, 48 weeks<br>Drug: ribavirin (fixed dose)<br>* Tablet, Oral, 800 mg, b.i.d., 48 weeks<br>Drug: ribavirin (weight-based dose)<br>* Tablet, Oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Achieving Undetectable HCV RNA at Week 12 |  | 12 weeks after first dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Achieving Undetectable HCV RNA at Week 4 and Week 12 | number of subjects with undetectable HCV RNA | 4 and 12 weeks after the first dose of study drug | 
| 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 | 
| 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 | 
| Median Trough Plasma Concentration (Ctrough) Ratios of Efavirenz and Tenofovir (Part B Only, Subjects on EFV-based HAART) | Ctrough ratio of HAART medication with telaprevir (test) and without telaprevir (reference) | through 12 weeks after first dose of study drug | 
| Median Trough Plasma Concentration (Ctrough) Ratios of Atazanavir (ATZ), Ritonavir, and Tenofovir (Part B Only, Subjects on ATV-based HAART) | Ctrough of HAART medication with telaprevir (test) and without telaprevir (reference) | through 12 weeks after first dose of study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VX-950, INCIVEK, INCIVO