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 (fixed dose) Drug: ribavirin (weight-based dose)	Phase II

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS Hepatitis Hepatitis A 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:	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
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

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:	Robert Kauffman, M.D., Ph.D., Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:	NCT00983853 History of Changes
Other Study ID Numbers:	VX08-950-110
Study First Received:	September 22, 2009
Last Updated:	October 14, 2010
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Vertex Pharmaceuticals Incorporated:

VX-950

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 February 09, 2012