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
  Purpose

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).


Condition Intervention Phase
Hepatitis C
HIV Infections
Drug: telaprevir or matching placebo
Biological: peginterferon alfa-2a
Drug: ribavirin (fixed dose)
Drug: ribavirin (weight-based dose)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)


Enrollment: 62
Study Start Date: October 2009
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00983853

Locations
United States, California
Beverly Hills, California, United States, 90211
San Diego, California, United States, 92093
San Francisco, California, United States, 94110
United States, Florida
Miami, Florida, United States, 33125
Orlando, Florida, United States, 32803
United States, Illinois
Chicago, Illinois, United States, 60612
United States, Maryland
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, New York
New York, New York, United States, 10029
United States, Ohio
Cincinnati, Ohio, United States, 45267
United States, Texas
Dallas, Texas, United States, 75204
France
Paris, France
Germany
Bonn-Venusberg, Germany
Hamburg, Germany
Spain
Barcelona, Spain
Madrid, Spain
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Tibotec Pharmaceutical Limited
Investigators
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
  More Information

No publications provided

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT00983853     History of Changes
Other Study ID Numbers: VX08-950-110
Study First Received: September 22, 2009
Results First Received: August 2, 2013
Last Updated: August 2, 2013
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Vertex Pharmaceuticals Incorporated:
VX-950
INCIVEK
INCIVO

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis
Hepatitis A
Hepatitis C
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors

ClinicalTrials.gov processed this record on July 28, 2014