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New Study- Boceprevir in HIV-HCV Coinfected Patients Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin
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Pilot Study to Assess the Efficacy and Safety of Boceprevir, in Combination With Peg-Interferon Alfa and Ribavirin, in Patients With HCV/HIV Co-infection Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin
This study is not yet open for participant recruitment.
Verified on April 2011 by French National Agency for Research on AIDS and Viral Hepatitis
First Received on March 25, 2011. Last Updated on April 13, 2011
http://www.clinicaltrials.gov/ct2/show/NCT01335529?rcv_s=02%2F14%2F2011&rank=800
Primary Outcome Measures:
* Sustained Virologic Response [ Time Frame: Week 72 or Week 96 (W72 or W96)
] [ Designated as safety issue: No ]
HCV-RNA measured 24 weeks after the end of the HCV treatment (W72 or W96)
A pharmacokinetic sub-study including 30 patients will be performed to estimate pharmacokinetic parameters of antiretroviral treatment (Atazanavir combined with Ritonavir, Raltegravir, Tenofovir) in combination with anti HCV treatment at baseline and W8 and pharmacokinetic parameters of Boceprevir at W8.
Purpose
The majority of Human immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) co-infected patients are non responders after 48 weeks of the current standard-of-care with Peg-Interferon/Ribavirin. The results of re-treatment are disappointing. The addition of Boceprevir to the current standard-of-care has been shown to increase the efficacy of therapy in HCV mono-infected patients previously treated with a bi-therapy. Knowing that HIV/HCV co-infected patients are subject to more rapid hepatic fibrosis as well as to increased risks of cirrhosis, end-stage liver disease and hepatocellular carcinoma, it is important to improve the response rate of the re-treatment of hepatitis C in these patients.
The aim of this pilot study is to evaluate the efficacy and safety of Boceprevir in combination with Peg-Interferon alfa 2b plus ribavirin, in patients co-infected with HIV and chronic genotype 1 HCV, and previously treated with Peg-Interferon/Ribavirin. 80 subjects will be enrolled. The primary endpoint will be the Sustained Virologic Response (SVR) defined as undetectable HCV-RNA at Week 24 after the end of therapy.
Secondary Outcome Measures Includes:
- Maximal Concentration (Cmax) of antiretroviral treatments [ Time Frame: Day 0 and W8 ] [ Designated as safety issue: No ]
Evaluation of Pharmacokinetic parameters (Cres, Cmax, AUC) of anti-retroviral treatments before (baseline) and after (W8) the starting of Boceprevir combination in a sub-group of subjects and according to UGTA1 polymorphism.
- Area Under the Curve (AUC) of antiretrovirals [ Time Frame: Day 0 and W8 ] [ Designated as safety issue: No ]
Evaluation of pharmacokinetic parameters (Cres, Cmax, AUC) of anti-retroviral treatments before (baseline) and after (W8) the starting of Boceprevir combination in a sub-group of subjects and according to UGTA1 polymorphism.
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