Low Dose Atazanavir/r Versus Standard Dose Atazanavir/r (LASA)

To demonstrate non-inferiority of treatment with atazanavir/ritonavir (ATV/r) 200/100 mg once daily (OD) compared to the control group (ATV/r 300/100 mg OD) in regards to the proportion of virologic responders (plasma HIV RNA < 200 copies/mL) at 48 weeks in ARV-experienced HIV-1 infected subjects.

Inclusion criteria

• HIV infected adults aged more than or equal to 18 years
• Received ritonavir boosted PI-based HAART for >3 months prior screening visit
• History of HIV RNA < 50 copies/ml within 12 months prior to screening visit
• HIV-RNA < 50 copies/ml at screening visit
• Signed written informed consent

Exclusion criteria

• Active AIDS-defining disease or active opportunistic infection
• History of virological failure (plasma HIV-RNA ≥1,000 copies/ml) while using any ritonavir boosted PI-based HAART
• Pregnancy or lactation at screening visit
• Relevant history or current conditions or illnesses that might interfere with drug absorption, distribution, metabolism or excretion e.g. chronic diarrhea, malabsorption
• Use of concomitant medication that may interfere with the pharmacokinetics of the study drugs e.g. rifampicin, proton pump inhibitor
• History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study
• ALT ≥200 IU/L at screening visit
• Creatinine clearance < 60 c.c. per min by Cockroft-Gault formula at screening visit