Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Blinded, Randomized, Placebo-controlled Trial in Genotype 1 Hepatitis C-Infected Subjects to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Repeated Doses of TMC435350, With or Without Peginterferon Alpha-2a and Ribavirin
Brief Summary: The purpose of this study is to investigate how efficient TMC435350 will work against the Hepatitis C virus genotype 1 (genotypes refer to the genetic constitution of the virus) and what the concentrations of TMC435350 in the blood are with or without pegylated interferon alpha-2a (PegIFNa-2a) or PegIFNa-2a plus ribavirin.


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A: Arm Label: TMC435 25 mg (Cohort 1/Panel A and B); Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: TMC435 75mg (Cohort 1/Panel A and B); Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: Placebo (Cohort 1/Panel A and B); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: TMC435 200 mg (Cohort 2, Panel A and B); Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: Placebo (Cohort 2/Panel A and B); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: TMC435 75 mg (Cohort 4/Panel C); Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: TMC435 150 mg (Cohort 4/Panel C); Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: TMC435 200 mg (Cohort 4/Panel C); Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: Placebo (Cohort 4/Panel C); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: TMC435 200 mg (Cohort 5/Panel D); Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Intervention Type: DRUG; Name: TMC435; Assigned to Arm(s): TMC435 150 mg (Cohort 4/Panel C), TMC435 200 mg (Cohort 2, Panel A and B), TMC435 200 mg (Cohort 4/Panel C), TMC435 200 mg (Cohort 5/Panel D), TMC435 25 mg (Cohort 1/Panel A and B), TMC435 75 mg (Cohort 4/Panel C), TMC435 75mg (Cohort 1/Panel A and B) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (Cohort 1/Panel A and B), Placebo (Cohort 2/Panel A and B), Placebo (Cohort 4/Panel C) | Intervention Type: DRUG; Name: Peginterferon (PegIFNα-2a); Assigned to Arm(s): Placebo (Cohort 1/Panel A and B), Placebo (Cohort 2/Panel A and B), Placebo (Cohort 4/Panel C), TMC435 150 mg (Cohort 4/Panel C), TMC435 200 mg (Cohort 2, Panel A and B), TMC435 200 mg (Cohort 4/Panel C), TMC435 200 mg (Cohort 5/Panel D), TMC435 25 mg (Cohort 1/Panel A and B), TMC435 75 mg (Cohort 4/Panel C), TMC435 75mg (Cohort 1/Panel A and B) | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): Placebo (Cohort 1/Panel A and B), Placebo (Cohort 2/Panel A and B), Placebo (Cohort 4/Panel C), TMC435 150 mg (Cohort 4/Panel C), TMC435 200 mg (Cohort 2, Panel A and B), TMC435 200 mg (Cohort 4/Panel C), TMC435 200 mg (Cohort 5/Panel D), TMC435 25 mg (Cohort 1/Panel A and B), TMC435 75 mg (Cohort 4/Panel C), TMC435 75mg (Cohort 1/Panel A and B)
B: Arm Label: Immediate Treatment; Type: EXPERIMENTAL; Interventions: Drug: Grazoprevir, Drug: Elbasvir | Arm Label: Deferred Treatment; Type: EXPERIMENTAL; Interventions: Drug: Grazoprevir, Drug: Elbasvir, Drug: Placebo to Grazoprevir, Drug: Placebo to Elbasvir | Arm Label: Intensive PK; Type: EXPERIMENTAL; Interventions: Drug: Grazoprevir, Drug: Elbasvir | Intervention Type: DRUG; Name: Grazoprevir; Assigned to Arm(s): Deferred Treatment, Immediate Treatment, Intensive PK | Intervention Type: DRUG; Name: Elbasvir; Assigned to Arm(s): Deferred Treatment, Immediate Treatment, Intensive PK | Intervention Type: DRUG; Name: Placebo to Grazoprevir; Assigned to Arm(s): Deferred Treatment | Intervention Type: DRUG; Name: Placebo to Elbasvir; Assigned to Arm(s): Deferred Treatment
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: A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk; Type: EXPERIMENTAL; Interventions: Drug: Grazoprevir, Drug: Elbasvir, Drug: Placebo to Elbasvir, Drug: Ribavirin | Arm Label: A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk; Type: EXPERIMENTAL; Interventions: Drug: Grazoprevir, Drug: Elbasvir, Drug: Placebo to Elbasvir, Drug: Ribavirin | Arm Label: A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk; Type: EXPERIMENTAL; Interventions: Drug: Grazoprevir, Drug: Elbasvir | Arm Label: B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk; Type: EXPERIMENTAL; Interventions: Drug: Grazoprevir, Drug: Elbasvir, Drug: Ribavirin | Arm Label: B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk; Type: EXPERIMENTAL; Interventions: Drug: Grazoprevir, Drug: Elbasvir, Drug: Ribavirin | Arm Label: B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk; Type: EXPERIMENTAL; Interventions: Drug: Grazoprevir, Drug: Elbasvir | Arm Label: B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk; Type: EXPERIMENTAL; Interventions: Drug: Grazoprevir, Drug: Elbasvir, Drug: Ribavirin | Arm Label: B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk; Type: EXPERIMENTAL; Interventions: Drug: Grazoprevir, Drug: Elbasvir | Arm Label: B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk; Type: EXPERIMENTAL; Interventions: Drug: Grazoprevir, Drug: Elbasvir, Drug: Ribavirin | Arm Label: B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk; Type: EXPERIMENTAL; Interventions: Drug: Grazoprevir, Drug: Elbasvir | Arm Label: B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk; Type: EXPERIMENTAL; Interventions: Drug: Grazoprevir, Drug: Elbasvir, Drug: Ribavirin | Arm Label: B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk; Type: EXPERIMENTAL; Interventions: Drug: Grazoprevir, Drug: Elbasvir | Arm Label: B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk; Type: EXPERIMENTAL; Interventions: Drug: Grazoprevir, Drug: Elbasvir, Drug: Ribavirin | Arm Label: B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk; Type: EXPERIMENTAL; Interventions: Drug: Grazoprevir, Drug: Elbasvir | Arm Label: B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk; Type: EXPERIMENTAL; Interventions: Drug: Grazoprevir, Drug: Elbasvir, Drug: Ribavirin | Arm Label: B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk; Type: EXPERIMENTAL; Interventions: Drug: Grazoprevir, Drug: Elbasvir | Arm Label: C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk; Type: EXPERIMENTAL; Interventions: Drug: Grazoprevir, Drug: Elbasvir, Drug: Ribavirin | Arm Label: C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk; Type: EXPERIMENTAL; Interventions: Drug: Grazoprevir, Drug: Elbasvir | Arm Label: D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk; Type: EXPERIMENTAL; Interventions: Drug: Grazoprevir, Drug: Elbasvir, Drug: Ribavirin | Arm Label: D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk; Type: EXPERIMENTAL; Interventions: Drug: Grazoprevir, Drug: Elbasvir, Drug: Ribavirin | Intervention Type: DRUG; Name: Grazoprevir; Assigned to Arm(s): A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk, A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk, A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk, B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk, B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk, B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk, B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk, B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk, B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk, B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk, B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk, B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk, B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk, B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk, B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk, B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk, C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk, C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk, D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk, D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | Intervention Type: DRUG; Name: Elbasvir; Assigned to Arm(s): A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk, A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk, A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk, B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk, B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk, B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk, B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk, B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk, B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk, B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk, B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk, B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk, B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk, B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk, B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk, B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk, C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk, C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk, D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk, D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk | Intervention Type: DRUG; Name: Placebo to Elbasvir; Assigned to Arm(s): A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk, A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk, A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk, B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk, B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk, B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk, B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk, B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk, B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk, B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk, C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk, D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk, D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk

Answer: A