A PHASE IIIB, OPEN-LABEL, RANDOMIZED, MULTI-CENTER STUDY COMPARING THE ANTIVI

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a multi-center, open label two treatment arm study to demonstrate the antiviral efficacy, safety, tolerability, and effect on serum lipids of an atazanavir/ritonavir (ATV/RTV) based regimen versus lopinavir/ritonavir (LPV/RTV) based regimen in subjects with Human Immunodeficiency Virus (HIV) who have exhibited initial virologic failure on non-nucleoside reverse transcriptase inhibitor (NNRTI)-based antiretroviral therapy. The study will target enrollment of 200 participants nationally with ten subjects to enroll locally. Study procedures will include cardiovascular risk and lifestyle assessments, medical histories, physical exams, CD4 counts, and blood and urine tests. About 11 study visits will be required over a two-year period.