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

August 2, 2013 updated by: Vertex Pharmaceuticals Incorporated

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
  • Germany
      • Bonn-Venusberg, Germany
      • Hamburg, Germany
  • Spain
      • Barcelona, Spain
      • Madrid, Spain
  • United States
    • California
      • Beverly Hills, California, United States, 90211
      • San Diego, California, United States, 92093
      • San Francisco, California, United States, 94110
    • Florida
      • Miami, Florida, United States, 33125
      • Orlando, Florida, United States, 32803
    • Illinois
      • Chicago, Illinois, United States, 60612
    • Maryland
      • Baltimore, Maryland, United States, 21287
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • New York
      • New York, New York, United States, 10029
    • Ohio
      • Cincinnati, Ohio, United States, 45267
    • Texas
      • Dallas, Texas, United States, 75204

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A
The dose of ribavirin used (fixed versus weight-based) is region dependent
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
Experimental: Part B
The dose of ribavirin used (fixed versus weight-based) is region dependent
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of Subjects Achieving Undetectable HCV RNA at Week 12
Time Frame: 12 weeks after first dose of study drug
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
Time Frame: 4 and 12 weeks after the first dose of study drug
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
Time Frame: 12 weeks after last dose of study drug
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
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)
Time Frame: through 12 weeks after first dose of study drug
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)
Time Frame: through 12 weeks after first dose of study drug
Ctrough of HAART medication with telaprevir (test) and without telaprevir (reference)
through 12 weeks after first dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vertex Pharmaceuticals Incorporated

Collaborators

Tibotec Pharmaceutical Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

September 22, 2009

First Submitted That Met QC Criteria

September 23, 2009

First Posted (Estimate)

September 24, 2009

Study Record Updates

Last Update Posted (Estimate)

October 10, 2013

Last Update Submitted That Met QC Criteria

August 2, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX08-950-110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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