ACTG 5175 - This study will learn if two different once-daily combinations of anti-HIV drugs works as well as the standard twice a day combination of anti-HIV drugs for the initial treatment of HIV infection.

Eligible candidates:

• candidates must have CD4+ cell count <300 within 90 days prior to study entry
• candidates must be naive to antiretroviral meds (have never taken HIV medications before)
• Women who have taken single dose NVP or ZDV during pregnancy to prevent MTCT are eligible
• Additional requirements will be discussed by the study nurse or doctor.

Study Objective:
This study will investigate whether a once-daily regimen containing two NRTIs plus a protease inhibitor is not inferior to a twice-daily regimen containing two NRTIs + NNRTI and if a once daily regimen that contains two NRTIs +NNRTI is not inferior to a twice-daily regimen that also contains two NRTIs + NNRTI.

Study Scheme:
STEP 1: Initial Treatment - All volunteers have an equal chance of getting ONE of the following treatments:

• Group A: Combivir (3TC/ZDV) twice daily plus Efavirenz (EFV) once daily.
• Group B: Emtriva (FTC) once daily plus Atazanavir (ATV) once daily plus Videx EC (ddI-EC) once daily.
• Group C: Emtriva (FTC) once daily plus Tenofovir once daily plus Efavirenz (EFV) once daily.

The study also provides alternative drugs if you have trouble taking one of the medications and additional treatment if treatment no longer helps decrease the viral load (the amount of virus in the blood).

A randomized open label study with duration of 2.5 years after randomization of the first participant, which ever occurs later in time.

Study Drugs:

• Didanosine Enteric Coated Capsules
• Zidovudine+ Lamivudine, CBV
• Efavirenz, EFV
• Tenofovir
• FTC, Emtricitabine, Coviracil
• ATVv

Study Status: Closed to enrollment.

Study Staff:

• Judith Aberg, MD
• Janet Forcht, RN
• Luis Vargas

Study Sponsors:

• AIDS Clinical Trials Group (NIH)

Study Volunteers Receive:

• Cost-free lab work
• Transportation reimbursement