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

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a Telaprevir

U.S. FDA Resources

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:	60
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
	Recruiting
San Francisco, California, United States, 94110
	Recruiting
La Jolla, California, United States, 92093
United States, Florida
	Recruiting
Orlando, Florida, United States, 32803
	Recruiting
Miami, Florida, United States, 33125
United States, Illinois
	Not yet recruiting
Chicago, Illinois, United States, 60612
United States, Maryland
	Recruiting
Baltimore, Maryland, United States, 21287
United States, Massachusetts
	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:	January 14, 2010
ClinicalTrials.gov Identifier:	NCT00983853 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vertex Pharmaceuticals Incorporated:

VX-950

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Communicable Diseases
Sexually Transmitted Diseases, Viral
Liver Diseases
Slow Virus Diseases
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Ribavirin
Hepatitis, Viral, Human
Infection
Therapeutic Uses
Growth Inhibitors

Angiogenesis Modulating Agents
Hepatitis C
Retroviridae Infections
RNA Virus Infections
Immune System Diseases
Growth Substances
Acquired Immunodeficiency Syndrome
Angiogenesis Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
Hepatitis
Digestive System Diseases
HIV Infections

ClinicalTrials.gov processed this record on February 08, 2010