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.
In a total number of 108 patients the protocol was evaluated but only in 102 the protocol efectively was presented. In the remaining 6 patients we don't believe the trial could be performed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain
Achievement of Sustained Virological Response (SVR) at 24 Weeks Post-Treatment
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.
Time frame: Week 24
Achievement of Sustained Virological Response at Weeks 2,4,8,12.
Proportion of participants with undetectable HCV RNA (\<15 IU/mL) at weeks 2, 4, 8, and 12 during treatment.
Time frame: Weeks 2, 4, 8, 12
The Proportion of Subjects With Undetectable HCV-RNA at FW 12.
The proportion of subjects with undetectable HCV-RNA at follow-up week 12.
Time frame: Week 12
The Proportion of Subjects With Undetectable HCV-RNA at 72 Weeks After Randomization.
The proportion of randomized subjects with undetectable HCV-RNA at 72 weeks after randomization.
Time frame: Week 72
Number of Adverse Events
Safety: number of adverse events
Time frame: From baseline to study completion (up to 72 weeks)
Resistance of HCV After Boceprevir (BOC) Containing Regimen
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).
Time frame: whenever resistance occurs during the study (from week 12 until the date the resistance occurs, assessed up to 72 weeks)
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