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.

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

August 31, 2013

Study Completion Date

November 30, 2013

Conditions
Hepatitis CHIV
Interventions
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)

Trial Locations (1)

00927

Fundacion de Investigacion de Diego, San Juan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

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. | Biotech Hunter | Biotech Hunter