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

Vertex Pharmaceuticals Incorporated62 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hepatitis C HIV Infections

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (16)

Unnamed facility

Beverly Hills, California, United States

Unnamed facility

San Diego, California, United States

Unnamed facility

San Francisco, California, United States

Outcomes

Primary Outcomes

Proportion of Subjects Achieving Undetectable HCV RNA at Week 12

Time frame: 12 weeks after first dose of study drug

Secondary Outcomes

Proportion of Subjects Achieving Undetectable HCV RNA at Week 4 and Week 12

number of subjects with undetectable HCV RNA

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: through 12 weeks after first dose of study drug

Data from ClinicalTrials.gov

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