Please select the arm or intervention descriptions that belong 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: Arm Label: PegIFN-2b + RBV; Type: PLACEBO_COMPARATOR; Interventions: Drug: PegIFN-2b, Drug: RBV, Drug: Placebo to Boceprevir | Arm Label: PegIFN-2b + RBV + Boceprevir; Type: ACTIVE_COMPARATOR; Interventions: Drug: PegIFN-2b, Drug: RBV, Drug: Boceprevir | Intervention Type: DRUG; Name: PegIFN-2b; Assigned to Arm(s): PegIFN-2b + RBV, PegIFN-2b + RBV + Boceprevir | Intervention Type: DRUG; Name: RBV; Assigned to Arm(s): PegIFN-2b + RBV, PegIFN-2b + RBV + Boceprevir | Intervention Type: DRUG; Name: Placebo to Boceprevir; Assigned to Arm(s): PegIFN-2b + RBV | Intervention Type: DRUG; Name: Boceprevir; Assigned to Arm(s): PegIFN-2b + RBV + Boceprevir
B: Arm Label: GSK2336805; Type: EXPERIMENTAL; Interventions: Drug: GSK2336805 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: GSK2336805 Matching Placebo | Arm Label: GSK2336805 + pegylated interferon alfa-2a + ribavrin; Type: EXPERIMENTAL; Interventions: Drug: GSK2336805, Drug: Pegylated interferon alfa-2a, Drug: Ribavirin | Arm Label: Placebo + pegylated interferon alfa-2a + ribavirin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Pegylated interferon alfa-2a, Drug: Ribavirin, Drug: GSK2336805 Matching Placebo | Intervention Type: DRUG; Name: GSK2336805; Assigned to Arm(s): GSK2336805, GSK2336805 + pegylated interferon alfa-2a + ribavrin | Intervention Type: DRUG; Name: Pegylated interferon alfa-2a; Assigned to Arm(s): GSK2336805 + pegylated interferon alfa-2a + ribavrin, Placebo + pegylated interferon alfa-2a + ribavirin | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): GSK2336805 + pegylated interferon alfa-2a + ribavrin, Placebo + pegylated interferon alfa-2a + ribavirin | Intervention Type: DRUG; Name: GSK2336805 Matching Placebo; Assigned to Arm(s): Placebo, Placebo + pegylated interferon alfa-2a + ribavirin
C: Arm Label: Placebo 12 Weeks (GT2/3); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo to match SOF, Drug: Placebo to match RBV | Arm Label: SOF 12 Weeks (GT2/3); Type: EXPERIMENTAL; Interventions: Drug: SOF, Drug: RBV | Arm Label: SOF 24 Weeks (GT3); Type: EXPERIMENTAL; Interventions: Drug: SOF, Drug: RBV | Intervention Type: DRUG; Name: SOF; Assigned to Arm(s): SOF 12 Weeks (GT2/3), SOF 24 Weeks (GT3) | Intervention Type: DRUG; Name: RBV; Assigned to Arm(s): SOF 12 Weeks (GT2/3), SOF 24 Weeks (GT3) | Intervention Type: DRUG; Name: Placebo to match SOF; Assigned to Arm(s): Placebo 12 Weeks (GT2/3) | Intervention Type: DRUG; Name: Placebo to match RBV; Assigned to Arm(s): Placebo 12 Weeks (GT2/3)
D: Arm Label: PegIFN/RBV; Type: ACTIVE_COMPARATOR; Interventions: Drug: PegIFN/RBV | Arm Label: BI 201335 for 12 or 24 weeks; Type: EXPERIMENTAL; Interventions: Drug: PegIFN/RBV, Drug: BI 201335 | Arm Label: Placebo and PegIFN/RBV; Type: ACTIVE_COMPARATOR; Interventions: Drug: PegIFN/RBV, Drug: Placebo | Intervention Type: DRUG; Name: PegIFN/RBV; Assigned to Arm(s): BI 201335 for 12 or 24 weeks, PegIFN/RBV, Placebo and PegIFN/RBV | Intervention Type: DRUG; Name: BI 201335; Assigned to Arm(s): BI 201335 for 12 or 24 weeks | Intervention Type: DRUG; Name: BI 201335; Assigned to Arm(s): BI 201335 for 12 or 24 weeks | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo and PegIFN/RBV

Answer: A