Skip to main content
OpenTrials
Completed

NCT Number: NCT00983853

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Genital Diseases HIV Infections Hepatitis Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Paris, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

telaprevir or matching placebo

Drug

Tablet, Oral, 750 mg, q8h, 12 weeks

peginterferon alfa-2a

Biological

Subcutaneous injection, 180 μg, once weekly, 48 weeks

ribavirin (fixed dose)

Drug

Tablet, Oral, 800 mg, b.i.d., 48 weeks

ribavirin (weight-based dose)

Drug

Tablet, Oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks

Primary outcomes

  1. Proportion of Subjects Achieving Undetectable HCV RNA at Week 12

    Time frame: 12 weeks after first dose of study drug

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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)

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Collaborators

  • Tibotec Pharmaceutical Limited

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
First posted
Sep 24, 2009
Registry last updated
Oct 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.