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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

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ClinicalTrials.gov Identifier: NCT00983853
Recruitment Status : Completed
First Posted : September 24, 2009
Results First Posted : October 10, 2013
Last Update Posted : October 10, 2013
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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).

Condition or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2009
Actual Primary Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Subjects Achieving Undetectable HCV RNA at Week 12 [ Time Frame: 12 weeks after first dose of study drug ]

Secondary Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT00983853     History of Changes
Other Study ID Numbers: VX08-950-110
First Posted: September 24, 2009    Key Record Dates
Results First Posted: October 10, 2013
Last Update Posted: October 10, 2013
Last Verified: August 2013

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

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