drugset
drugset / Trial / 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.

NCT01565889 ↗

Phase 1/2 Completed 52 enrolled Gilead Sciences
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2012-03
Primary completion
2013-08
Completion
2013-11

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Atazanavir Other / unclassified 400 mg Oral
Subject Darunavir Small molecule 800 mg Oral
Subject EFV/FTC/TDF Unknown 200 mg Oral
Subject EFV/FTC/TDF Unknown 300 mg Oral
Subject EFV/FTC/TDF Unknown 600 mg Oral
Subject Efavirenz Other / unclassified 600 mg Oral
Subject FTC/TDF Unknown 200 mg Oral
Subject FTC/TDF Unknown 300 mg Oral
Subject Raltegravir Other / unclassified 400 mg Oral
Subject Ritonavir Other / unclassified 100 mg Oral
Subject Sofosbuvir Small molecule 400 mg Oral
Subject ZDV/3TC Unknown 150 mg Oral
Subject ZDV/3TC Unknown 300 mg Oral
Background Peginterferon alfa-2a Protein / enzyme biologic 180 ug Subcutaneous
Background Ribavirin Small molecule 1000 mg Oral
Background Ribavirin Small molecule 1200 mg Oral

Indications

HIV infectious disease hepatitis C virus infection