Status:
COMPLETED
An Efficacy and Safety Study of Telaprevir in Patients Infected With Both Chronic Hepatitis C Virus (HCV-1) and Human Immunodeficiency Virus (HIV-1)
Lead Sponsor:
Janssen-Cilag International NV
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of telaprevir, given with pegylated-interferon-alfa-2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in the treatment of hepatitis C in pa...
Detailed Description
This is an open-label (both participant and investigator know the name of the medication given at a certain moment), single-arm, multicenter study in HCV treatment-naive and treatment-experienced pati...
Eligibility Criteria
Inclusion
- Chronic (detectable 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 HIV-1 infection greater than 6 months before the screening visit
- 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 undetectable by an ultrasensitive assay at least once within 90 days of the screening visit
- No HIV RNA values greater than 200 copies/mL within 6 months of the screening visit
- Currently taking one of the permitted anti-HIV regimens for greater than or equal to12 weeks
Exclusion
- Anticipated need to switch anti-HIV regimen 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
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT01513941
Start Date
April 1 2012
End Date
June 1 2014
Last Update
May 5 2016
Active Locations (31)
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1
Cairns, Australia
2
Darlinghurst, Australia
3
Melbourne, Australia
4
Campinas, Brazil