To evaluate the safety and efficacy of a novel nucleoside sparing regimen containing atazanavir, ritonavir and efavirenz, using two different doses of atazanavir.

Condition	Intervention	Phase
HIV/AIDS	Drug: Atazanavir  Drug: Efavirenz  Drug: Ritonavir	Phase III

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Provide written informed consent
• HIV positive with plasma HIV RNA viral load of ≥ 1000 copies/mL and CD4 cell count of ≥ 50 cells/mm3
• Antiretroviral (ARV) naive prior to enrollment
• Normal plasma triglycerides ≤ 200 mg/dL
• Women of child-bearing age must use effective barrier contraception

Exclusion Criteria:

• Pregnancy or breast feeding
• Evidence of resistance to antiretroviral drugs
• History of elevated blood cholesterol or triglycerides
• History of diabetes
• Hypersensitivity to any component of the study drugs
• Any cholesterol or triglyceride lowering medications in the past six months
• Use of growth hormone, megastrol acetate, or anabolic steroids in the past six months
• Imprisonment or involuntary incarceration for medical treatment

California
      Local Institution, San Francisco,  California,  United States
District of Columbia
      Local Institution, Washington,  District of Columbia,  United States
Florida
      Local Institution, Atlantis,  Florida,  United States
      Local Institution, Orlando,  Florida,  United States
      Local Institution, South Miami,  Florida,  United States
      Local Institution, Tampa,  Florida,  United States
Louisiana
      Local Institution, New Orleans,  Louisiana,  United States
Massachusetts
      Local Institution, Boston,  Massachusetts,  United States
Michigan
      Local Institution, Berkley,  Michigan,  United States
Missouri
      Local Institution, St. Louis,  Missouri,  United States
North Carolina
      Local Institution, Huntersville,  North Carolina,  United States
South Carolina
      Local Institution, Clumbia,  South Carolina,  United States
Texas
      Local Institution, Dallas,  Texas,  United States
      Local Institution, Dallas,  Texas,  United States
      Local Institution, Dallas,  Texas,  United States
      Local Institution, Dallas,  Texas,  United States
      Local Institution, Austin,  Texas,  United States
Virginia
      Local Institution, Hampton,  Virginia,  United States

Study ID Numbers:  AI424-121
Last Updated:  August 25, 2005
Record first received:  August 25, 2005
ClinicalTrials.gov Identifier:  NCT00135343
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30