Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Parallel-Group, Dose-Ranging Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Antiviral Activity of VX-222 and Telaprevir in Combination With and Without Peginterferon-Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C
Brief Summary: The purpose of this study is to assess the safety and efficacy of combination treatment with VX-222 and telaprevir administered for 12 weeks with and without peginterferon-alfa-2a and/or ribavirin. The subjects enrolled in this study are chronically infected with hepatitis C virus (HCV) genotype 1 and will not have previously received treatment for their HCV infection.

This study will include an Investigational Phase and Extension Phase. These phases will contain a Treatment Period and a Follow-up Period. All subjects will be enrolled in the Investigational Phase of this study. Subjects who fail treatment during the Investigational Phase will have the option to enter the Extension Phase at which point they will be eligible to receive peginterferon alfa-2a and ribavirin for a total of 48 weeks.

Based on an evaluation of on-treatment safety, pharmacokinetic and antiviral data from patients in each arm of the trial, Vertex may elect to enroll up to two additional treatment arms (Treatment Arm E and Treatment Arm F) that will evaluate telaprevir/VX-222-based combination therapy. The components of the treatment regimens of these arms will be selected based on clinical data that emerges from the four initially-studied regimens. If enacted, up to 25 patients are expected to enroll in each additional treatment arm.

If Treatment Arm E or Treatment Arm F is discontinued subjects meeting certain criteria will have the option to enter a telaprevir-containing Rollover Phase. Subjects who do not meet the eligibility criteria to enter the Rollover Phase may elect to enter the Extension Phase.


Options:
A: Arm Label: Part 1: Single Dose Escalation in Healthy Subjects; Type: EXPERIMENTAL; Interventions: Drug: GSK2336805 10mg, Drug: GSK2336805 30mg, Drug: GSK2236805 100mg, Drug: GSK2236805 200mg | Arm Label: Part 2: Repeat Dose Escalation in Healthy Subjects; Type: EXPERIMENTAL; Interventions: Drug: GSK2236805 10mg, Drug: GSK2236805 dose to be determined up to 100mg | Arm Label: Part 3: Single Dose Escalation in HCV Infected Subjects; Type: EXPERIMENTAL; Interventions: Drug: GSK2236805 5mg, Drug: GSK2236805 30mg, Drug: GSK2236805 100mg | Intervention Type: DRUG; Name: GSK2336805 10mg; Assigned to Arm(s): Part 1: Single Dose Escalation in Healthy Subjects | Intervention Type: DRUG; Name: GSK2336805 30mg; Assigned to Arm(s): Part 1: Single Dose Escalation in Healthy Subjects | Intervention Type: DRUG; Name: GSK2236805 100mg; Assigned to Arm(s): Part 1: Single Dose Escalation in Healthy Subjects | Intervention Type: DRUG; Name: GSK2236805 200mg; Assigned to Arm(s): Part 1: Single Dose Escalation in Healthy Subjects | Intervention Type: DRUG; Name: GSK2236805 10mg; Assigned to Arm(s): Part 2: Repeat Dose Escalation in Healthy Subjects | Intervention Type: DRUG; Name: GSK2236805 dose to be determined up to 100mg; Assigned to Arm(s): Part 2: Repeat Dose Escalation in Healthy Subjects | Intervention Type: DRUG; Name: GSK2236805 5mg; Assigned to Arm(s): Part 3: Single Dose Escalation in HCV Infected Subjects | Intervention Type: DRUG; Name: GSK2236805 30mg; Assigned to Arm(s): Part 3: Single Dose Escalation in HCV Infected Subjects | Intervention Type: DRUG; Name: GSK2236805 100mg; Assigned to Arm(s): Part 3: Single Dose Escalation in HCV Infected Subjects
B: 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)
C: Arm Label: Treatment Arm A; Type: EXPERIMENTAL; Interventions: Drug: telaprevir, Drug: VX-222 | Arm Label: Treatment Arm B; Type: EXPERIMENTAL; Interventions: Drug: telaprevir, Drug: VX-222 | Arm Label: Treatment Arm C; Type: EXPERIMENTAL; Interventions: Drug: telaprevir, Drug: VX-222, Drug: ribavirin, Biological: peginterferon-alfa-2a | Arm Label: Treatment Arm D; Type: EXPERIMENTAL; Interventions: Drug: telaprevir, Drug: ribavirin, Biological: peginterferon-alfa-2a, Drug: VX-222 | Arm Label: Treatment Arm E; Type: EXPERIMENTAL; Interventions: Drug: telaprevir, Drug: ribavirin, Drug: VX-222 | Arm Label: Treatment Arm F; Type: EXPERIMENTAL; Interventions: Drug: telaprevir, Drug: ribavirin, Drug: VX-222 | Intervention Type: DRUG; Name: telaprevir; Assigned to Arm(s): Treatment Arm A, Treatment Arm B, Treatment Arm C, Treatment Arm D, Treatment Arm E, Treatment Arm F | Intervention Type: DRUG; Name: VX-222; Assigned to Arm(s): Treatment Arm A, Treatment Arm C | Intervention Type: DRUG; Name: ribavirin; Assigned to Arm(s): Treatment Arm C, Treatment Arm D, Treatment Arm E, Treatment Arm F | Intervention Type: BIOLOGICAL; Name: peginterferon-alfa-2a; Assigned to Arm(s): Treatment Arm C, Treatment Arm D | Intervention Type: DRUG; Name: VX-222; Assigned to Arm(s): Treatment Arm B, Treatment Arm D, Treatment Arm E, Treatment Arm F
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: BMS-791325, Drug: Placebo | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: BMS-791325, Drug: Placebo | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: BMS-791325, Drug: Placebo | Arm Label: 4; Type: EXPERIMENTAL; Interventions: Drug: BMS-791325, Drug: Placebo | Intervention Type: DRUG; Name: BMS-791325; Assigned to Arm(s): 1, 2, 3, 4 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 1, 2, 3, 4

Answer: C