Conditions: Hepatitis C HIV Infections
Keywords: VX-950 INCIVEK INCIVO
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 62
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether the combination of telaprevir, peginterferon alfa-2a, and ribavirin is safe and effective in treating hepatitis C virus (HCV) infection in subjects who are infected with both HCV and human immunodeficiency virus (HIV).

Detailed description:

Arms:
arm 1: The dose of ribavirin used (fixed versus weight-based) is region dependent arm 2: The dose of ribavirin used (fixed versus weight-based) is region dependent

Interventions: intervention 1: telaprevir or matching placebo intervention 2: telaprevir or matching placebo intervention 3: peginterferon alfa-2a intervention 4: ribavirin (fixed dose) intervention 5: ribavirin (weight-based dose)
Intervention descriptions: intervention 1: Tablet, Oral, 750 mg, q8h, 12 weeks intervention 2: Tablet, Oral, 750 mg or 1125 mg, q8h, 12 weeks intervention 3: Subcutaneous injection, 180 μg, once weekly, 48 weeks intervention 4: Tablet, Oral, 800 mg, b.i.d., 48 weeks intervention 5: Tablet, Oral, 1000 mg for subjects weighing \<75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks

Protocol document: