Clinical trial NCT00983853: Safety and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects Co-Infected With Hepatitis C Virus (HCV) and HIV
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
HIV Infections
Keywords: VX-950
INCIVEK
INCIVO
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
Collaborators: name: Tibotec Pharmaceutical Limited
First posted: 2009-09-24
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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

Primary outcomes:
measure: Proportion of Subjects Achieving Undetectable HCV RNA at Week 12
timeFrame: 12 weeks after first dose of study drug
Secondary outcomes:
measure: Proportion of Subjects Achieving Undetectable HCV RNA at Week 4 and Week 12
timeFrame: 4 and 12 weeks after the first dose of study drug
measure: Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks (SVR12) and 24 Weeks (SVR24) After Last Planned Dose of Study Treatment
timeFrame: 12 weeks after last dose of study drug
measure: Effect of Efavirenz-based (EFV) and Atazanavir-based (ATV/r) Highly Active Antiretroviral Therapy(HAART) on Telaprevir Exposure
timeFrame: through 12 weeks after first dose of study drug
measure: Median Trough Plasma Concentration (Ctrough) Ratios of Efavirenz and Tenofovir (Part B Only, Subjects on EFV-based HAART)
timeFrame: through 12 weeks after first dose of study drug
measure: Median Trough Plasma Concentration (Ctrough) Ratios of Atazanavir (ATZ), Ritonavir, and Tenofovir (Part B Only, Subjects on ATV-based HAART)
timeFrame: through 12 weeks after first dose of study drug
Other outcomes:
Locations:
city: Beverly Hills
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: New York
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Dallas
country: United States
state: Texas
city: Paris
country: France
city: Bonn-Venusberg
country: Germany
city: Hamburg
country: Germany
city: Barcelona
country: Spain
city: Madrid
country: Spain
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Sulkowski MS, Sherman KE, Dieterich DT, Bsharat M, Mahnke L, Rockstroh JK, Gharakhanian S, McCallister S, Henshaw J, Girard PM, Adiwijaya B, Garg V, Rubin RA, Adda N, Soriano V. Combination therapy with telaprevir for chronic hepatitis C virus genotype 1 infection in patients with HIV: a randomized trial. Ann Intern Med. 2013 Jul 16;159(2):86-96. doi: 10.7326/0003-4819-159-2-201307160-00654.