Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV

Inclusion Criteria

• Virologic failure to 2 or more highly active antiretroviral therapy (HAART) regimens that, in total, have included at least one drug from all approved classes protease inhibitors, non-nucleoside reverse transcriptase inhibitors, nucleoside reverse transcriptase inhibitors (PI, NNRTI, NRTI):
• Currently on a failing HAART regimen with 2 qualifying plasma viral load measurements (hospital/clinic value within 4 weeks of screening with viral load equivalent to =>1,000 c/mL on the Roche Amplicor[TM] and central lab measurements of =>1,000 c/mL (Roche Amplicor[TM]) within 4 weeks of randomization
• Cluster of Differentiation 4 (CD4) cell count =>50 cells/mm3 obtained within 4 weeks prior to randomization
• =>16 years of age (or minimum age as determined by local regulations or as legal requirements dictate);
• History of prior virologic response to at least one HAART regimen, defined as a 1.0 log10 decline or a decline in viral load to 3 days) of atazanavir, TVF or LPV/RTV; if history of SQV, then must be phenotypically sensitive
• the current failing antiretroviral regimen must have been administered for at least eight weeks at he initiation of screening and must not include both a PI and NNRTI
• Presence of a newly diagnosed HIV-related opportunistic infection or any medical requiring acute therapy at the time of enrollment
• Proven or suspected acute hepatitis in the 30 days prior to study entry. Subjects with chronic hepatitis are eligible provided that their liver function enzymes (ALT/AST) are 6 loose stools/day for at least 7 days consecutive days) within 30 days prior to study entry
• Pregnancy or breast-feeding
• History of hemophilia
• Presence of cardiomyopathy
• Any one of the following:
• Heart rate-corrected QT (QTc) interval >450 msec on the screening electrocardiogram (EKG)
• Heart rate 3 seconds seen on EKG
• Clinical symptoms potentially related to heart block
• Third degree heart block
• History of acute or chronic pancreatitis
• If choosing 2'-3' dideoxyinosine (ddI) or 2',3'-didehydro-3'-deoxythymidine (d4T) as the NRTI: History or signs and symptoms of bilateral peripheral neuropathy => Grade 2 at the time of screening
• Inability to tolerate oral medications
• Any other clinical conditions or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for study or unable to comply with the dosing requirements.