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.


Options:
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: BI201335 12W; Type: EXPERIMENTAL; Interventions: Drug: PegIFN/RBV, Drug: BI201335 | Arm Label: BI 201335 24W; Type: EXPERIMENTAL; Interventions: Drug: BI201335 24W, Drug: PegIFN/RBV | Arm Label: BI 201335 24 W; Type: EXPERIMENTAL; Interventions: Drug: PegIFN/RBV, Drug: Bi 201335 | Intervention Type: DRUG; Name: PegIFN/RBV; Assigned to Arm(s): BI 201335 24 W | Intervention Type: DRUG; Name: PegIFN/RBV; Assigned to Arm(s): BI201335 12W | Intervention Type: DRUG; Name: BI201335; Assigned to Arm(s): BI201335 12W | Intervention Type: DRUG; Name: BI201335 24W; Assigned to Arm(s): BI 201335 24W | Intervention Type: DRUG; Name: PegIFN/RBV; Assigned to Arm(s): BI 201335 24W | Intervention Type: DRUG; Name: Bi 201335; Assigned to Arm(s): BI 201335 24 W
C: Arm Label: SOF+RBV+placebo; Type: EXPERIMENTAL; Interventions: Drug: SOF, Drug: RBV, Drug: Placebo to match SOF, Drug: Placebo to match RBV | Arm Label: SOF+RBV; Type: EXPERIMENTAL; Interventions: Drug: SOF, Drug: RBV | Intervention Type: DRUG; Name: SOF; Assigned to Arm(s): SOF+RBV, SOF+RBV+placebo | Intervention Type: DRUG; Name: RBV; Assigned to Arm(s): SOF+RBV, SOF+RBV+placebo | Intervention Type: DRUG; Name: Placebo to match SOF; Assigned to Arm(s): SOF+RBV+placebo | Intervention Type: DRUG; Name: Placebo to match RBV; Assigned to Arm(s): SOF+RBV+placebo
D: Arm Label: 20mg; Type: EXPERIMENTAL; Interventions: Drug: BI201335 | Arm Label: 48mg; Type: EXPERIMENTAL; Interventions: Drug: BI201335 | Arm Label: 120mg; Type: EXPERIMENTAL; Interventions: Drug: BI201335 | Arm Label: 240mg; Type: EXPERIMENTAL; Interventions: Drug: BI201335 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: BI201335; Assigned to Arm(s): 240mg | Intervention Type: DRUG; Name: BI201335; Assigned to Arm(s): 120mg | Intervention Type: DRUG; Name: BI201335; Assigned to Arm(s): 48mg | Intervention Type: DRUG; Name: BI201335; Assigned to Arm(s): 20mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: A