Safety and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects Co-Infected With Hepatitis C Virus (HCV) and HIV
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
1 other identifier
interventional
62
4 countries
16
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2009
CompletedFirst Posted
Study publicly available on registry
September 24, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedResults Posted
Study results publicly available
October 10, 2013
CompletedOctober 10, 2013
August 1, 2013
2.4 years
September 22, 2009
August 2, 2013
August 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Subjects Achieving Undetectable HCV RNA at Week 12
12 weeks after first dose of study drug
Secondary Outcomes (5)
Proportion of Subjects Achieving Undetectable HCV RNA at Week 4 and Week 12
4 and 12 weeks after the first dose of study drug
Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks (SVR12) and 24 Weeks (SVR24) After Last Planned Dose of Study Treatment
12 weeks after last dose of study drug
Effect of Efavirenz-based (EFV) and Atazanavir-based (ATV/r) Highly Active Antiretroviral Therapy(HAART) on Telaprevir Exposure
through 12 weeks after first dose of study drug
Median Trough Plasma Concentration (Ctrough) Ratios of Efavirenz and Tenofovir (Part B Only, Subjects on EFV-based HAART)
through 12 weeks after first dose of study drug
Median Trough Plasma Concentration (Ctrough) Ratios of Atazanavir (ATZ), Ritonavir, and Tenofovir (Part B Only, Subjects on ATV-based HAART)
through 12 weeks after first dose of study drug
Study Arms (2)
Part A
EXPERIMENTALThe dose of ribavirin used (fixed versus weight-based) is region dependent
Part B
EXPERIMENTALThe dose of ribavirin used (fixed versus weight-based) is region dependent
Interventions
Tablet, Oral, 1000 mg for subjects weighing \<75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Unknown Facility
Beverly Hills, California, 90211, United States
Unknown Facility
San Diego, California, 92093, United States
Unknown Facility
San Francisco, California, 94110, United States
Unknown Facility
Miami, Florida, 33125, United States
Unknown Facility
Orlando, Florida, 32803, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Baltimore, Maryland, 21287, United States
Unknown Facility
Boston, Massachusetts, 02114, United States
Unknown Facility
New York, New York, 10029, United States
Unknown Facility
Cincinnati, Ohio, 45267, United States
Unknown Facility
Dallas, Texas, 75204, United States
Unknown Facility
Paris, France
Unknown Facility
Bonn-Venusberg, Germany
Unknown Facility
Hamburg, Germany
Unknown Facility
Barcelona, Spain
Unknown Facility
Madrid, Spain
Related Publications (1)
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.
PMID: 23685940DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Monitor
- Organization
- Vertex Pharmaceuticals Incorporated
Study Officials
- STUDY DIRECTOR
Medical Monitor
Vertex Pharmaceuticals Incorporated
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2009
First Posted
September 24, 2009
Study Start
October 1, 2009
Primary Completion
March 1, 2012
Last Updated
October 10, 2013
Results First Posted
October 10, 2013
Record last verified: 2013-08