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

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:

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:

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:


Hepatitis C Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Liver Diseases RNA Virus Infections Virus Diseases Interferon-alpha Peginterferon alfa-2a	Ribavirin Anti-Infective Agents Antimetabolites Antiviral Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015