A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on Their First PI-Based Antiretroviral Therapy

Key Inclusion Criteria:

• Must be on current HIV treatment regimen at least 3 to 6 months prior to study (this must be one protease inhibitor, or ritonavir-boosted protease inhibitor, and two nucleoside reverse transcriptase inhibitors) must be subject's first PI ever received
• Plasma HIV-1 RNA level < 50 c/mL within 3 to 6 months prior to study start
• Fasting LDL cholesterol > 130 mg/dL

Key Exclusion Criteria:

• WOCBP who do not use effective barrier contraception for any reason
• Women who are pregnant or breast feeding
• A life expectancy < 12 months
• Presence of a newly diagnosed HIV-related OI or any medical condition requiring acute therapy at the time of enrollment
• Cushing's Syndrome
• Uncontrolled diabetes mellitus, history of diabetic ketoacidosis or hyperosmolar syndrome
• Untreated hypothyroidism or hyperthyroidism
• Nephrotic syndrome or significant proteinuria
• Obstructive liver disease
• Active alcohol or substance abuse
• Proven or suspected acute hepatitis in the 30 days prior to study entry
• Intractable diarrhea (greater than or equal to 6 loose stools/day for at least 7 consecutive days) within 30 days prior to study start
• History of acute or chronic pancreatitis
• Inability to swallow capsules
• Presence of cardiomyopathy
• Known history of prolonged QTc interval
• Any of the following:

• clinical symptoms potentially related to heart block
• heart rate < 40 bpm
• any of the following EKG abnormalities:

i) pause length > 3 seconds ii) second or third degree AV heart block iii) QTc interval > 450 msec for males iv) QTc interval > 470 msec for females

• Fasting serum triglyceride level > 750 mg/dL
• Any of the following lab values within 2 weeks of starting study drug:

• serum creatinine greater to or equal to 1.5 times the upper limit of normal
• total serum lipase greater than or equal to 1.4 times the upper limit of normal
• liver transaminases greater than or equal to 3 times the upper limit of normal
• total serum bilirubin greater than or equal to 1.5 times the upper limit of normal
• Hypersensitivity to any component of the formulation of study drug
• Use of any lipid-lowering agent within 4 weeks prior or during study
• Use of a PI-containing ARV regimen prior to entry which is comprised of more than one PI
• Inclusion of an NNRTI in the PI-containing regimen
• Prisoners or subjects involuntary incarcerated for treatment of psychiatric or physical illness