hiv info source nyu medical center bellevue hospital center

A5202 - This study will be looking at first treatment combinations for HIV infection. We want to see if one combination is more effective than another. The study also looks at how easy the medications are to take and their side effects.

Eligible candidates:

  • Must have a viral load greater than 1000 copies
  • Have never taken antiretroviral treatment in the past
  • Cannot be resistant to any HIV medications
  • Cannot become pregnant or breastfeed during the study
  • other requirements which your study nurse will discuss with you

Study Objective:
A5202 is a phase III, randomized, four-arm study, comparing the efficacy, safety, and tolerability of open-label ritonavir (RTV)-enhanced atazanavir (ATV) to efavirenz (EFV), in combination with either daily emtricitabine (FTC)/tenofovir (TDF) or abacavir (ABC)/lamivudine (3TC) and of blinded ABC/3TC compared to FTC/TDF in combination with either RTV-enhanced ATV or EFV as initial therapy for HIV-1 infection.

Study Scheme:
Each group will be taking a different set of HIV medications. You will know if you are taking Efavirenz or Atazanavir with Ritonavir. You will not know if you are taking Abacavir/Lamivudine or Emtricitabine/Tenofovir. The possible treatments that you may be assigned to are:

  • Arm A: Efavirenz (Sustiva) 600 mg once daily + FTC (Emtricitabine) 200 mg/TDF (Tenofovir) 300 mg once daily + ABC (Abacavir)/3TC (Lamivudine) placebo once daily.
  • Arm B: Efavirenz (Sustiva) 600 mg + ABC (Abacavir) 600 mg/3TC (lamivudine) 300 mg once daily + FTC (Emtricitabine)/TDF (Tenofovir) placebo once daily.
  • Arm C: Atazanavir (Reyataz) 300 mg once daily with Ritonavir (Norvir) 100 mg once daily + FTC (Emtricitabine) 200 mg/TDF (Tenofovir) 300 mg once daily + ABC (Abacavir)/3TC (Lamivudine) placebo once daily.
  • Arm D: Atazanavir (Reyataz) 300 mg with Ritonavir (Norvir) 100 mg once daily ABC (Abacavir) 600 mg/3TC (Lamivudine) 300 mg once daily + FTC (Emtricitabine)/TDF (Tenofovir) placebo once daily.

Study Drugs:

  • Abacavir, ABC
  • Efavirenz, EFV
  • Tenofovir
  • FTC, Emtricitabine, Coviracil
  • 3TC, Lamivudine, Epivir
  • Ritonavir, RTV
  • ATV

Study Status: Closed to enrollment.

Study Staff:

Study Sponsors:

  • AIDS Clinical Trials Group (NIH)

Study Volunteers Receive:

  • Cost-free lab work
  • Transportation reimbursement