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.

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Darunavir; Efavirenz; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lamivudine; Peginterferon alfa-2a; Ribavirin; Ritonavir; Sofosbuvir; Tenofovir; Zidovudine

Criteria

Inclusion Criteria:

• Healthy according to medical history and physical examination with exception of HCV and HIV diagnoses

• Confirmation of Chronic HCV infection

• Confirmation of Chronic HIV-1 infection

• On a stable protocol approved HIV antiretroviral (ARV) regimen with undetectable HIV-RNA

• Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication

• Subjects must be naive to treatment for chronic HCV infection

Exclusion Criteria:

• Known or suspected cirrhosis

• History of any other clinically significant chronic liver disease

• A history consistent with decompensated liver disease.

• Use of any prohibited medications as defined by the protocol

• Pregnant or nursing female or male with pregnant female partner

• Contraindication to PEG or RBV therapy (for Part B)

• Clinically relevant drug or alcohol abuse