Telaprevir Coinfection Study Open - 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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Telaprevir Coinfection Study Open - 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 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). 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 Contact: Central Contact Center 877-634-VRTX medicalinfo@...

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: 68Study Start Date: October 2009Estimated Study Completion Date: June 2012Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure) 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 Locations United States, CaliforniaRecruitingBeverly Hills, California, United States, 90211Not yet recruitingLa Jolla, California, United States, 92093RecruitingSan Francisco, California, United States, 94110 United States, FloridaRecruitingMiami, Florida, United States, 33125RecruitingOrlando, Florida, United States, 32803 United States, IllinoisNot yet recruitingChicago, Illinois, United States, 60612 United States, landRecruitingBaltimore, land, United States, 21287 United States, MassachusettsNot yet recruitingBoston, Massachusetts, United States, 02114 United States, New YorkRecruitingNew York, New York, United States, 10029 United States, OhioRecruitingCincinnati, Ohio, United

States, 45267 United States, TexasRecruitingDallas, Texas, United States, 75204

http://www.natap.org/2010/HCV/031210_01.htm