Telaprevir Open-Label Study in Co-Infected Patients

Conditions: Chronic hepatitis C infection
MedDRA version: 16.0Level: LLTClassification code 10019752Term: Hepatitis C virus (HCV)System Organ Class: 100000004848
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2011-003593-85-DE

Lead Sponsor: Janssen-Cilag International NV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1000

Inclusion Criteria

- Have diagnosis of HIV-1 or HIV-2 infection, or HIV-1 and HIV-2
coinfection for more than 6 months before the screening visit.
- Should have been on a stable permissible HAART regimen for more than 8 weeks before Day 1 without switches. OR Not
on a HAART regimen and not expected to start HIV treatment during the study, ie, have CD4 count of =500 cells/mm3 and a HIV-1 and/or HIV-2 viral load =50,000 copies/mL at screening
- If on stable permissible HAART regimen, have CD4 count =200
cells/mm3 or =15% and HIV-1 and/or HIV-2 viral load <50 copies/mL for at least 6 months before starting treatment is recommended
- Have evidence of HCV infection genotype 1 (molecular assay)
- Have a quantifiable plasma HCV RNA
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 980
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- Is eligible for enrollment into an ongoing clinical study of telaprevir
- Is infected or coinfected with HCV of another genotype than genotype 1
- Has a contraindication to the administration of Peg-IFN-alfa or RBV, or medical history or laboratory values that preclude treatment with Peg-IFN-alfa or RBV according to the respective local prescribing information
- Have any contraindication to the currently prescribed HAART regimen at screening. Note: Patients who have a contraindication to a nonprescribed permissible HAART medication are not excluded.
- Positive human leukocyte antigen (HLA)-B5701 genotyping result at screening (or documented result prior to screening) if abacavir is a component of HAART

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this open-label safety study is to collect safety and tolerability data on telaprevir treatment in combination with Peg-IFNalfa and RBV in subjects with HIV/genotype 1 chronic HCV coinfection with severe fibrosis or compensated cirrhosis who are not eligible for enrollment into an ongoing clinical study of telaprevir.;Secondary Objective: ;Primary end point(s): Treatment-emergent adverse events.;Timepoint(s) of evaluation of this end point: from first use of the medicinal product to 30 days after<br>administration of the last dose of investigational product (telaprevir)

Secondary Outcome Measures