Clinical trial NCT01565889
Conditions: Hepatitis C HIV
Sponsor: Gilead Sciences
Start date: 2012-03-01; Completion date: 2013-11-01
Enrollment: 52 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study consists of 2 parts, Part A and Part B. Part A, the Phase 1 drug interaction/early viral kinetic study, will evaluate the effect of selected antiretroviral therapies on the safety, viral kinetics, and pharmacokinetics of sofosbuvir (GS-7977; PSI-7977) and its metabolites in participants with HIV and hepatitis C virus (HCV) coinfection. Part B, the Phase 2 treatment study, will investigate the efficacy and safety of sofosbuvir, pegylated interferon alpha (PEG) and ribavirin (RBV) in participants with HIV/HCV coinfection.

Detailed description:

Arms: arm 1: Participants with a prestudy regimen of EFV/FTC/TDF will receive SOF+EFV/FTC/TDF FDC for 7 days, followed by EFV/FTC/TDF FDC (or EFV+FTC/TDF) for 7 days, coadministered once daily in the evening under fasting conditions. arm 2: Participants with a prestudy regimen of EFV+ZDV/3TC will receive SOF+EFV+ZDV/3TC for 7 days followed by EFV+ZDV/3TC for 7 days. Sofosbuvir and EFV will be administered once daily in the evening under fasting conditions; ZDV/3TC will be administered twice daily, in the morning without regard to food and in the evening on an empty stomach. arm 3: Participants with a prestudy regimen of RTV+ATV+FTC/TDF will receive SOF+RTV+ATV+FTC/TDF for 7 days followed by RTV+ATV+FTC/TDF for 7 days coadministered once daily in the morning with food. arm 4: Participants with a prestudy regimen of RTV+DRV+FTC/TDF will receive SOF+RTV+DRV+FTC/TDF for 7 days followed by RTV+DRV+FTC/TDF for 7 days coadministered once daily in the morning with food. arm 5: Participants with a prestudy regimen of RAL+FTC/TDF will receive SOF+RAL+FTC/TDF for 7 days followed by RAL+FTC/TDF for 7 days. Sofosbuvir and FTC/TDF will be administered once daily in the morning with food; RAL will be administered twice daily, in the morning with food and in the evening without regard to food. arm 6: Participants will receive SOF+PEG+RBV for 12 weeks.
Interventions: intervention 1: SOF intervention 2: EFV/FTC/TDF intervention 3: EFV intervention 4: ZDV/3TC intervention 5: ATV intervention 6: Ritonavir intervention 7: FTC/TDF intervention 8: DRV intervention 9: RAL intervention 10: PEG intervention 11: RBV
Intervention descriptions: intervention 1: Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily intervention 2: Efavirenz (EFV) 600 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination (FDC) tablet administered orally once daily intervention 3: Efavirenz (EFV) 600 mg tablet administered orally once daily intervention 4: Zidovudine (ZDV) 300 mg/lamivudine (3TC) 150 mg FDC tablet administered orally twice daily intervention 5: Atazanavir (ATV) 400 mg tablet administered orally once daily intervention 6: Ritonavir (RTV) 100 mg tablet administered orally once daily intervention 7: FTC/TDF (200/300 mg) FDC tablet administered orally once daily intervention 8: Darunavir (DRV) 800 mg (2 × 400 mg tablets) administered orally once daily intervention 9: Raltegravir (RAL) 400 mg administered administered orally twice daily intervention 10: Pegylated interferon alfa (PEG) 180 μg administered once weekly by subcutaneous injection intervention 11: Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol documents: