Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Placebo-controlled, Dose-ranging Study to Evaluate the Safety, Tolerability and Antiviral Activity of Combination Treatment With an HCV Polymerase Inhibitor (RO5024048) and an HCV Protease Inhibitor (RO5190591) in Genotype 1 Chronic Hepatitis C Patients. INFORM 1
Brief Summary: This 7 cohort study will evaluate the efficacy and safety of combination treatment with an HCV nucleoside polymerase inhibitor(RO5024048)and an HCV protease inhibitor(RO5190591/ITMN-191/danoprevir) in patients with chronic hepatitis C, genotype 1.Cohorts A,B,C,D and G will be treatment-naive patients, cohort E will be treatment-experienced excluding null responders, and cohort F will be null responders. Cohorts A and B will evaluate doses of 500mg po bid RO5024048 and 100mg po q8h RO5190591, alone or in combination, for up to 7 or 14 days. Cohort C will evaluate combination treatment with either 1000mg po bid RO5024048 and 100mg q8h RO5190591 or 500mg po bid RO5024048 and 200mg q8h RO5190591 for 14 days. Cohort D will evaluate 1000mg po bid RO5024048 and 200mg q8h RO5190591 for 14 days.Cohort E will evaluate 1000mg RO5024048/600mg RO5190591 po twice daily for 14 days, and Cohorts F and G will evaluate 1000mg RO5024048/900mg RO5190591 po twice daily for 14 days. Cohorts will be tested sequentially or in parallel, if supported by appropriate safety and pharmacokinetic data.Following the last dose of study medication patients have the option of continuing treatment with Standard of care therapies. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Options:
A: Arm Label: SOF+PEG+RBV 12 weeks; Type: EXPERIMENTAL; Interventions: Drug: Sofosbuvir, Drug: RBV, Drug: PEG | Arm Label: SOF+PEG+RBV 24 weeks; Type: EXPERIMENTAL; Interventions: Drug: Sofosbuvir, Drug: RBV, Drug: PEG | Arm Label: SOF+PEG+RBV 12 week/Rerandomization Group; Type: EXPERIMENTAL; Interventions: Drug: Sofosbuvir, Drug: RBV, Drug: PEG | Intervention Type: DRUG; Name: Sofosbuvir; Assigned to Arm(s): SOF+PEG+RBV 12 week/Rerandomization Group, SOF+PEG+RBV 12 weeks, SOF+PEG+RBV 24 weeks | Intervention Type: DRUG; Name: RBV; Assigned to Arm(s): SOF+PEG+RBV 12 week/Rerandomization Group, SOF+PEG+RBV 12 weeks, SOF+PEG+RBV 24 weeks | Intervention Type: DRUG; Name: PEG; Assigned to Arm(s): SOF+PEG+RBV 12 week/Rerandomization Group, SOF+PEG+RBV 12 weeks, SOF+PEG+RBV 24 weeks
B: Arm Label: ABT-450/r/ABT-267 and ABT-333, plus RBV; Type: EXPERIMENTAL; Interventions: Drug: ABT-450/r/ABT-267, ABT-333, Drug: Ribavirin | Arm Label: Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV; Type: EXPERIMENTAL; Interventions: Drug: ABT-450/r/ABT-267, ABT-333, Drug: Ribavirin, Drug: Placebo for ABT-450/r/ABT-267, Drug: Placebo for ABT-333, Drug: Placebo for ribavirin | Intervention Type: DRUG; Name: ABT-450/r/ABT-267, ABT-333; Assigned to Arm(s): ABT-450/r/ABT-267 and ABT-333, plus RBV, Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): ABT-450/r/ABT-267 and ABT-333, plus RBV, Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV | Intervention Type: DRUG; Name: Placebo for ABT-450/r/ABT-267; Assigned to Arm(s): Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV | Intervention Type: DRUG; Name: Placebo for ABT-333; Assigned to Arm(s): Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV | Intervention Type: DRUG; Name: Placebo for ribavirin; Assigned to Arm(s): Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV
C: Arm Label: Cohort A; Type: EXPERIMENTAL; Interventions: Drug: RO5024048 | Arm Label: Cohort B; Type: EXPERIMENTAL; Interventions: Drug: danoprevir | Arm Label: Cohort C; Type: EXPERIMENTAL; Interventions: Drug: danoprevir | Arm Label: Cohort D; Type: EXPERIMENTAL; Interventions: Drug: danoprevir | Arm Label: Cohort E; Type: EXPERIMENTAL; Interventions: Drug: danoprevir | Arm Label: Cohort F; Type: EXPERIMENTAL; Interventions: Drug: danoprevir | Arm Label: Cohort G; Type: EXPERIMENTAL; Interventions: Drug: danoprevir | Intervention Type: DRUG; Name: RO5024048; Assigned to Arm(s): Cohort A | Intervention Type: DRUG; Name: danoprevir; Assigned to Arm(s): Cohort B | Intervention Type: DRUG; Name: danoprevir; Assigned to Arm(s): Cohort C | Intervention Type: DRUG; Name: danoprevir; Assigned to Arm(s): Cohort D | Intervention Type: DRUG; Name: danoprevir; Assigned to Arm(s): Cohort E | Intervention Type: DRUG; Name: danoprevir; Assigned to Arm(s): Cohort F, Cohort G
D: Arm Label: TMC435; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b), Drug: Ribavirin (RBV) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b), Drug: Ribavirin (RBV) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: TMC435; Assigned to Arm(s): TMC435 | Intervention Type: DRUG; Name: Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b); Assigned to Arm(s): Placebo, TMC435 | Intervention Type: DRUG; Name: Ribavirin (RBV); Assigned to Arm(s): Placebo, TMC435

Answer: C