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

Status and phase: Completed; Phase 2

Conditions: Hepatitis C; HIV Infections

Treatments: Drug: ribavirin (weight-based dose); Biological: peginterferon alfa-2a; Drug: ribavirin (fixed dose); Drug: telaprevir or matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00983853

VX08-950-110

Details and patient eligibility

About

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).

Enrollment: 62 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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62 participants in 2 patient groups

Part A

Experimental group

Description:

The dose of ribavirin used (fixed versus weight-based) is region dependent

Treatment:

Drug: ribavirin (weight-based dose)

Drug: ribavirin (fixed dose)

Drug: telaprevir or matching placebo

Drug: telaprevir or matching placebo

Biological: peginterferon alfa-2a

Part B

Experimental group

Description:

The dose of ribavirin used (fixed versus weight-based) is region dependent

Treatment:

Drug: ribavirin (weight-based dose)

Drug: ribavirin (fixed dose)

Drug: telaprevir or matching placebo

Drug: telaprevir or matching placebo

Biological: peginterferon alfa-2a