Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00983853
First received: September 22, 2009
Last updated: August 2, 2013
Last verified: August 2013

September 22, 2009
August 2, 2013
October 2009
March 2012   (final data collection date for primary outcome measure)
Proportion of Subjects Achieving Undetectable HCV RNA at Week 12 [ Time Frame: 12 weeks after first dose of study drug ] [ Designated as safety issue: No ]
  • Plasma HCV RNA level [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Safety (adverse events, physical examination findings, clinical laboratory results, and vital sign assessments) [ Time Frame: through 4 weeks after last dose of study drug ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00983853 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    number of subjects with undetectable HCV RNA
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Ctrough ratio of HAART medication with telaprevir (test) and without telaprevir (reference)
  • 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 ] [ Designated as safety issue: No ]
    Ctrough of HAART medication with telaprevir (test) and without telaprevir (reference)
  • HCV viral kinetics [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Plasma concentrations of study drugs (Cmax, AUC, and tmax) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Undetectable HCV RNA [ Time Frame: 4 weeks, 12 weeks, end of treatment, 12 weeks after last dose, 24 weeks after last dose ] [ Designated as safety issue: No ]
  • Amino acid sequence of the HCV NS3•4A protease [ Time Frame: through 24 weeks after last dose of study drug ] [ Designated as safety issue: No ]
  • Plasma concentrations of highly active antiretroviral therapy (HAART) medications (Part B only) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects Co-Infected With Hepatitis C Virus (HCV) and HIV
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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Hepatitis C
  • HIV Infections
  • 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 A
    The dose of ribavirin used (fixed versus weight-based) is region dependent
    Interventions:
    • Drug: telaprevir or matching placebo
    • Biological: peginterferon alfa-2a
    • Drug: ribavirin (fixed dose)
    • Drug: ribavirin (weight-based dose)
  • Experimental: Part B
    The dose of ribavirin used (fixed versus weight-based) is region dependent
    Interventions:
    • Drug: telaprevir or matching placebo
    • Biological: peginterferon alfa-2a
    • Drug: ribavirin (fixed dose)
    • Drug: ribavirin (weight-based dose)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
Not Provided
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Spain
 
NCT00983853
VX08-950-110
Yes
Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
Tibotec Pharmaceutical Limited
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP