NCT01565889

Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients.

Part A: Drug Interaction Study Between GS-7977 and Antiretroviral Therapy (ARV) Combinations of Efavirenz, Tenofovir and Emtricitabine; Efavirenz, Zidovudine and Lamivudine; Atazanavir/Ritonavir, Tenofovir and Emtricitabine; Darunavir/Ritonavir, Tenofovir and Emtricitabine; Raltegravir, Tenofovir and Emtricitabine in Human Immunodeficiency Virus and Hepatitis C Virus (HIV/HCV) Co-infected Patients. Part B: A Phase 2, Open-Label Study to Investigate the Efficacy and Safety of GS-7977 With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naïve HIV/HCV Co-infected Patients.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C
• HIV

Interventions

Type	Name	Description
DRUG	SOF	Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
DRUG	EFV/FTC/TDF	Efavirenz (EFV) 600 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination (FDC) tablet administered orally once daily
DRUG	EFV	Efavirenz (EFV) 600 mg tablet administered orally once daily
DRUG	ZDV/3TC	Zidovudine (ZDV) 300 mg/lamivudine (3TC) 150 mg FDC tablet administered orally twice daily
DRUG	ATV	Atazanavir (ATV) 400 mg tablet administered orally once daily
DRUG	Ritonavir	Ritonavir (RTV) 100 mg tablet administered orally once daily
DRUG	FTC/TDF	FTC/TDF (200/300 mg) FDC tablet administered orally once daily
DRUG	DRV	Darunavir (DRV) 800 mg (2 × 400 mg tablets) administered orally once daily
DRUG	RAL	Raltegravir (RAL) 400 mg administered administered orally twice daily
DRUG	PEG	Pegylated interferon alfa (PEG) 180 μg administered once weekly by subcutaneous injection
DRUG	RBV	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)

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-08-01
• Completion: 2013-11-01
• First posted: 2012-03-29
• Last updated: 2014-10-01
• Results posted: 2014-10-01

Locations

1 site across 1 country: Puerto Rico