Tenofovir Disoproxil Fumarate/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects

PHASE3CompletedINTERVENTIONAL
Enrollment

517

Participants

Timeline

Start Date

July 31, 2003

Primary Completion Date

February 28, 2005

Study Completion Date

June 30, 2009

Conditions
HIV Infections
Interventions
DRUG

Emtricitabine (FTC)

Capsule containing 200 mg FTC, taken once daily, for 96 weeks

DRUG

Tenofovir Disoproxil Fumarate (TDF)

Tablet containing 300 mg TDF, taken once daily, for 96 weeks

DRUG

Efavirenz (EFV)

Tablet containing 600 mg EFV, taken once daily, for 96 weeks

DRUG

FTC/TDF

Fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg, once daily, from Week 96 to 144

DRUG

FTC/TDF/EFV

Fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg/EFV 600 mg, taken once daily, from Week 144 to 240

DRUG

Lamivudine/zidovudine

Fixed-dose combination tablet containing lamivudine 150 mg/zidovudine 300 mg, taken twice daily, for 240 weeks

Trial Locations (5)

20036

Capital Medical Associates, P.C., Washington D.C.

28078

Jemsek Clinic, Huntersville

32804

Orlando Immunology Center, Orlando

60657

NorthStar Medical Center, Chicago

90211

AIDS Healthcare Foundation Research, Beverly Hills

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY