Conditions: Hepatitis C, Genotype 1
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 549
Healthy volunteers: no

Brief summary:
The purpose of this open label study is to evaluate the safety and efficacy of daclatasvir plus pegylated interferon-alfa 2a and ribavirin in untreated hepatitis C virus in patients coinfected with HIV

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Daclatasvir intervention 2: Ribavirin intervention 3: PEG-Interferon alfa 2a
Intervention descriptions: intervention 1: Tablets; oral; 30, 60, or 90 mg; once daily; up to 24 weeks intervention 2: Tablets; oral; for patients weighing \<75 kg, the total dose is 1000 mg per day (2 200-mg tablets in the morning and 3 200-mg tablets in the evening); for patients weighing \>75 kg, the total dose is 1200 mg per day (3 200-mg tablets in morning and 3 200-mg tablets in evening); twice daily with food; 24 or 48 weeks depending on response intervention 3: Syringe, subcutaneous injection, 180 μg, once weekly, 24 or 48 weeks depending on response

Protocol document: