CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
SOF +10 moredrug
Likely dose
SOF 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01565889
NCT01565889Phase 2Completed
CompareCT.gov

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.

Gilead Sciences·interventional·Posted Mar 29, 2012·Updated Oct 1, 2014

In Brief

A Phase 2 clinical trial evaluating SOF, EFV/FTC/TDF, and 9 other interventions for Hepatitis C and HIV. Completed, enrolled 52 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, HIV
CountriesPuerto Rico
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 29, 2012
Enrollment StartMar 1, 2012
Primary CompletionAug 1, 2013
Study CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 14.3 years ago

Interventions

SOFdrug

Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily

EFV/FTC/TDFdrug

Efavirenz (EFV) 600 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination (FDC) tablet administered orally once daily

EFVdrug

Efavirenz (EFV) 600 mg tablet administered orally once daily

ZDV/3TCdrug

Zidovudine (ZDV) 300 mg/lamivudine (3TC) 150 mg FDC tablet administered orally twice daily

ATVdrug

Atazanavir (ATV) 400 mg tablet administered orally once daily

Ritonavirdrug

Ritonavir (RTV) 100 mg tablet administered orally once daily

FTC/TDFdrug

FTC/TDF (200/300 mg) FDC tablet administered orally once daily

DRVdrug

Darunavir (DRV) 800 mg (2 × 400 mg tablets) administered orally once daily

RALdrug

Raltegravir (RAL) 400 mg administered administered orally twice daily

PEGdrug

Pegylated interferon alfa (PEG) 180 μg administered once weekly by subcutaneous injection

RBVdrug

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)