An Efficacy and Safety Study of Telaprevir in Patients Infected With Both Chronic HCV-1 and HIV-1
- Conditions
- Chronic hepatitis C infectionMedDRA version: 20.0 Level: LLT Classification code 10019752 Term: Hepatitis C virus (HCV) System Organ Class: 100000004848Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-004928-35-GB
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 162
- HCV RNA more than 6 months prior screening or histological diagnosis based on liver biopsy or fibroscan) HCV infection genotype 1 with HCV RNA level > 1,000 IU/mL.
- Confirmed diagnosis of HIV-1 infection >6 months before the screening visit.
- CD4 count >300 cells/mm3 at screening and no value <200 cells/mm3 within 6 months of screening visit.
- HIV-1 RNA undetectable by an ultrasensitive assay at least once within 90 days of the screening visit.
- No HIV RNA values >200 copies/mL within 6 months of the screening visit.
- HIV-1 RNA <50 copies/mL by Roche Taqman HIV-1 RNA v2 at screening.
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 HAART regimens from screening through the Telaprevir treatment period
- 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
- Pre-existing psychiatric condition
- Evidence of hepatic decompensation.
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, Peg-IFN-alfa-2a, and RBV in HCV-1/HIV-1 coinfected subjects as measured by sustained virologic response (SVR12planned). SVR12planned is defined as having an undetectable HCV RNA level 12 weeks after the last planned dose of study medication.;Secondary Objective: Reference is made to section 2.1 (p.33 - 34) of the Clinical Trial Protocol.;Primary end point(s): Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels ;Timepoint(s) of evaluation of this end point: 12 weeks after the last planned dose of study drug
- Secondary Outcome Measures
Name Time Method