This study is currently recruiting participants

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 is currently recruiting participants.
Verified by Vertex Pharmaceuticals Incorporated, March 2010
First Received: September 22, 2009 Last Updated: March 9, 2010


Sponsor: Vertex Pharmaceuticals Incorporated
Collaborator: Tibotec Pharmaceutical Limited
Information provided by: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT00983853

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
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:

* 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 ]
* Plasma HCV RNA level [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

* 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 ]


Estimated Enrollment: 68
Study Start Date: October 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Part A: Experimental 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
Tablet, Oral, 800 mg, b.i.d., 48 weeks
Part B: Experimental 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
Tablet, Oral, 800 mg, 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00983853

Contacts
Contact: Central Contact Center 877-634-VRTX medicalinfo@vrtx.com

Locations
United States, California
Recruiting
Beverly Hills, California, United States, 90211
Not yet recruiting
La Jolla, California, United States, 92093
Recruiting
San Francisco, California, United States, 94110
United States, Florida
Recruiting
Miami, Florida, United States, 33125
Recruiting
Orlando, Florida, United States, 32803
United States, Illinois
Not yet recruiting
Chicago, Illinois, United States, 60612
United States, Maryland
Recruiting
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Not yet recruiting
Boston, Massachusetts, United States, 02114
United States, New York
Recruiting
New York, New York, United States, 10029
United States, Ohio
Recruiting
Cincinnati, Ohio, United States, 45267
United States, Texas
Recruiting
Dallas, Texas, United States, 75204
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 ( Robert Kauffman, M.D., Ph.D. )
Study ID Numbers: VX08-950-110
Study First Received: September 22, 2009
Last Updated: March 9, 2010
ClinicalTrials.gov Identifier: NCT00983853 History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Vertex Pharmaceuticals Incorporated:
VX-950