An Efficacy and Safety Study of Telaprevir in Patients Infected With Both Chronic HCV-1 and HIV-1
- Conditions
- Chronic hepatitis C infectionMedDRA version: 16.0Level: LLTClassification code 10019752Term: Hepatitis C virus (HCV)System Organ Class: 100000004848Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-004928-35-SE
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
- Chronic (detectable hepatitis C virus (HCV) ribonucleic acid (RNA) more than 6 months prior screening or histological diagnosis based on liver biopsy or fibroscan) HCV infection genotype 1 with HCV RNA level greater than 1,000 IU/mL
- Confirmed diagnosis of Human immunodeficiency virus-1 (HIV-1) infection more than than 6 months before the screening visit
- Cluster of differentiation 4 (CD4) count greater than 300 cells/mm3 at screening and no value less than 200 cells/mm3 within 6 months of screening visit
- HIV-1 RNA less than 50 copies/mL or patient must have HIV-1 RNA undetectable by a local specific HIV RNA test data at least once within 6 months of prior to the screening visit
- No HIV RNA values greater than 200 copies/mL within 6 months of the screening visit (or not greater than the lower limit of detection for assays with a limit of 500 copies/mL)
- Currently taking one of the permitted anti- HIV regimens for greater than or equal to12 weeks
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 146
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4
- Anticipated need to switch anti-HIV regimen from screening through the Telaprevir treatment period through Week 14
- Infection or co-infection with HCV other than genotype 1
- Contraindication to the administration of Peg-IFN-alfa or RBV
- Hepatitis B virus (HBV) co-infection
- Acute or active condition of HIV-associated opportunistic infection within 6 months of screening
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to assess the antiviral efficacy of telaprevir,<br>Peg-IFN-alfa-2a, and RBV in HCV-1/HIV-1 coinfected subjects as<br>measured by sustained virologic response (SVR12planned).<br>SVR12planned is defined as having HCV RNA levels < 25 IU/mL 12<br>weeks after the last planned dose of HCV study medication.;Secondary Objective: Reference is made to section 2.1 (p.39 - 40) of the Clinical Trial Protocol.;Primary end point(s): Number of patients achieving sustained virologic response (SVR)<br>12 planned;Timepoint(s) of evaluation of this end point: Week 60
- Secondary Outcome Measures
Name Time Method