Status:
COMPLETED
Telaprevir Open-Label Study in Co-Infected Patients
Lead Sponsor:
Janssen-Cilag International NV
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to collect safety and tolerability data on telaprevir treatment in combination with Peg-IFN-alfa and RBV in patients with HIV/genotype 1 chronic HCV coinfection with sever...
Detailed Description
In this study, all patients will receive open-label (all people involved know the identity of the intervention) telaprevir in addition to Peg IFN-alfa and RBV for treatment of hepatitis C virus (HCV) ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT01500616
Start Date
June 1 2012
End Date
August 1 2014
Last Update
August 18 2016
Active Locations (29)
Enter a location and click search to find clinical trials sorted by distance.
1
Antwerp, Belgium
2
Brussels, Belgium
3
Charleroi, Belgium
4
Ghent, Belgium