Conditions: Hepatitis C, Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 310
Healthy volunteers: no

Brief summary:
the aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV treatment-naive or relapsers patients coinfected with HIV

Detailed description:

Arms:
arm 1: patient to receive two capsules of BI 201335 once a day for 12 weeks and pegIFN/RBV for 24 or 48 weeks arm 2: patient to receive two capsules of BI 201335 once a day for 24 weeks and PegIFN/RBV for 24 or 48 weeks arm 3: patient to receive one capsule of BI 201335 once a day for 24 weeks and pegIFN/RBV for 24 or 48 weeks

Interventions: intervention 1: PegIFN/RBV intervention 2: PegIFN/RBV intervention 3: BI201335 intervention 4: BI201335 24W intervention 5: PegIFN/RBV intervention 6: Bi 201335
Intervention descriptions: intervention 1: PegIFN/RBV for 24 or 48w intervention 2: PegIFN/RBV for 24 or 48w intervention 3: BI201335 for 12w intervention 4: BI201335 for 24w intervention 5: PegIFN/RBV for 24 or 48w intervention 6: BI 201335 for 24 w

Protocol document: