HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin (BOC-HIV)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01718301|
Recruitment Status : Completed
First Posted : October 31, 2012
Last Update Posted : July 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C HIV Infections COINFECTION||Drug: boceprevir Drug: Ribavirin Drug: Peginterferon alfa-2a Drug: Peginterferon alfa-2b||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||128 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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 Eudra CT2012-003984-23|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||June 2015|
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: Peginterferon alfa-2a
Drug: Peginterferon alfa-2b
- Achievement of sustained virological response (SVR) at week 24 [ Time Frame: Week 24 ]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 ]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 ]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 ]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) ]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) ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718301
|Hospital Clinic i Provincial de Barcelona|
|Barcelona, Spain, 08036|
|Principal Investigator:||Josep Mallolas, MD||Hospital Clínic i Provincial de Barcelona|