Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected With HIV and Hepatitis C (Protocol No. P05411)
Brief Summary: The primary objective of this trial is to compare the efficacy of boceprevir (SCH 503034) 800 mg three times a day (TID) orally (PO) in combination with peginterferon alfa-2b (PegIFN-2b) 1.5 µg/kg weekly (QW) subcutaneously (SC) plus weight-based dosing (WBD) of ribavirin (RBV) (600 mg/day to 1400 mg/day) PO to therapy with PegIFN-2b + RBV alone in adult participants coinfected with human immunodeficiency virus (HIV) and previously untreated chronic hepatitis C virus (HCV) genotype 1.

Boceprevir is a potent, orally administered, novel serine protease inhibitor, specifically designed to inhibit the HCV nonstructural protein 3 (NS3) protease and, thereby, inhibit viral replication in HCV-infected host cells. The mechanism of inhibition represents a new mechanism of action compared to both interferon alfa and ribavirin. Based on previous experience with PegIFN-2b and RBV in combination with boceprevir in the HCV-monoinfected population, this combination treatment is expected to provide significant benefit to the HIV/HCV coinfected population. Given the high unmet medical need of these participants and the benefit of the addition of boceprevir to PegIFN-2b/RBV, it is important to demonstrate the safety and efficacy of boceprevir in combination with PegIFN-2b/RBV in participants coinfected with HIV/HCV.

This is a randomized, multi-center trial, double-blinded for boceprevir or placebo in combination with open-label PegIFN-2b/RBV in participants coinfected with HIV and previously untreated chronic HCV (genotype 1), to be conducted in conformance with Good Clinical Practice (GCP). This trial consists of two arms, one control arm (Arm 1) and one experimental arm (Arm 2). Participants in the control arm (Arm 1) may receive boceprevir/PegIFN-2b/RBV via a crossover arm.


Options:
A: Percentage of Participants Achieving Sustained Viral Response (SVR) at Follow-up Week 24 (FW24) Among Randomized Participants Who Received At Least One Dose of Trial Medication (Up to Week 72)
B: Number of Participant Achieving Rapid Virological Response (RVR) at Day 28, Nominal Analysis (Day 28); Number of Participant Achieving RVR at Day 28, (Primary and Supportive Analyses) (Day 28); Probability of Participants With HCV Genotype 1 Achieving RVR At Day 28, Nominal Analysis (Day 28); Probability of Participants With HCV Genotype 1 Achieving RVR at Day 28, Primary and Supportive Analyses (Day 28); Number of Participants With HCV Genotype 1 With Virologic Response (Day 7, 14 and 21); Change From Baseline in HCV Viral Load During 24 Hour (h) Following a Single Dose of GSK2336805 on the Log 10 Scale (Day 1 (Baseline [Pre-dose], 1, 2, 4, 6, and 8 and 24 h)); Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Event (SAE) During Treatment Period (Up to Day 28); Change From Baseline in QTcF Interval at Day 2 and 28 (Baseline (Day 1, Pre-dose ), Day 2 and Day 28)
C: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Adverse Events Leading to Permanent Discontinuation of Study Drug(s) (Up to 24 weeks)
D: Sustained Virological Response 12 Weeks Post-treatment (SVR12) (12 weeks post treatment, up to 60 weeks)

Answer: A