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

NCT00983853 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2013-10-10

Study results available
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Summary

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).

Conditions

  • Hepatitis C
  • HIV Infections

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Vertex Pharmaceuticals Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-03-31

Countries

  • United States
  • France
  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00983853 on ClinicalTrials.gov