A Study to Evaluate Safety and Efficacy of Boceprevir-response Guided Therapy in Controlled HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin
The primary objective of this study is to evaluate the safety and efficacy of a Response Guided Therapy of boceprevir 800 mg dosed three times a day (TID) orally (PO) in combination with Peginterferon (either alpha 2b or alpha 2a) and Ribavirin in HIV/HCV genotype 1 infected patients that failed to previous HCV therapy.
HCV and HIV Seropositive Coinfection
Drug: Peginterferon alfa-2a
Drug: Peginterferon alfa-2b
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- Achievement of sustained virological response (SVR) at week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]The primary efficacy endpoint is the achievement of SVR, defined as undetectable plasma HCV-RNA at Follow-up Week (FW) 24. If a subject is missing FW 24 data and has undetectable HCV-RNA level at FW 12, the subject would be considered an SVR.
- Achievement of sustained virological response at weeks 2,4,8,12. [ Time Frame: Weeks 2, 4, 8, 12 ] [ Designated as safety issue: No ]The proportion of subjects with virological response (eg. undetectable HCV-RNA at Weeks 2, 4, 8, or 12) in subjects who achieve SVR.
- The proportion of subjects with undetectable HCV-RNA at FW 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]The proportion of subjects with undetectable HCV-RNA at FW 12.
- The proportion of subjects with undetectable HCV-RNA at 72 weeks after randomization. [ Time Frame: Week 72 ] [ Designated as safety issue: No ]The proportion of subjects with undetectable HCV-RNA at 72 weeks after randomization.
- Number of adverse events [ Time Frame: From baseline to study completion (up to 72 weeks) ] [ Designated as safety issue: Yes ]Safety: number of adverse events
- Resistance of HCV after boceprevir (BOC) containing regimen [ Time Frame: whenever resistance occurs during the study (from week 12 until the date the resistance occurs, assessed up to 72 weeks) ] [ Designated as safety issue: No ]Resistance of HCV after boceprevir containing regimen. Blood samples will be collected at baseline and after HCV virological failure and resistance analysis will be done at the end of the study in a single Center (Hospital Clínic-Barcelona).
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: boceprevir + ribavirin + peginterferon
boceprevir 800 mg three times a day (v.o.) in combination with peginterferon (alfa-2b or alfa-2a) and ribavirin
|Drug: boceprevir Drug: Ribavirin Drug: Peginterferon alfa-2a Drug: Peginterferon alfa-2b|
|Contact: Anna Cruceta, MD||932275400 ext email@example.com|
|Principal Investigator:||Josep Mallolas, MD||Hospital Clínic i Provincial de Barcelona|