Study of Adherence Effects and Clinical Outcomes of Kaletra Based HIV Antiviral Therapy

Inclusion Criteria

• •Subject is documented HIV positive
• •Subject is greater than or equal to 18 years of age.
• •Subject currently on a regimen of either NNRTI + 2 Nucleoside Reverse Transcriptase Inhibitors NRTIs), two or three NRTIs who have failed regimen as evidenced by two consecutive viral loads with values over 1,000 copies/mL, the last one within the last three months, or
• •Naïve subjects to ARV regimen who are required to begin a PI containing HAART regimen, or
• •Subjects who have become intolerant to their current antiretroviral regimen and are required to be changed to a first time PI containing HAART regimen.
• •Subject had laboratory testing within the previous three months and the most recent testing demonstrates all of the following: Hemoglobin \>8.0 g/dL; Absolute neutrophil count \>750 cells/mL; Platelet count \>20,000/mL; ALT or AST \<3 x Upper Limit of Normal (ULN); Creatinine \<1.5 x ULN; Triglycerides \<750 mg/dL.
• •Subjects have no have evidence of grade III or IV adverse event or laboratory abnormality.