ACTG A5142: A PHASE III, RANDOMIZED, OPEN-LABEL COMPARISON OF LOPINAVIR/RITONAVI

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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 trial of the Adult AIDS Clinical Trial Group sponsored by the National Institutes of Health, National Institute of Alergy and Infectious Diseases, Division of AIDS. This study will compare three different anti-HIV drug regimens as first-time treatments for HIV infection. Currently anti-HIV drugs are from one to three classes: non-nucleoside analogues, nucleoside analogues and protease inhibitors. Each of the three regimens in this study use medication from two anti-HIV drug classes but spares a third class. Each regimen spares a different class of anti-HIV drug. This study will look at the effectiveness and safety of the three drug regimens and how well these regimens are tolerated. The study will also look at the effect of these three anti-HIV regiments on changes in the changes in the subjects' metabolism because people treated for HIV sometimes develop high blood sugar, higher than normal levels of fats (such as triglycerides and cholesterol) in their blood, loss of fat in the arms and legs, or increased fat in other parts of the body such as the upper back and abdomen. The GCRC will be asked to perform DEXA scans on the subjects who agree to participate in this trial. Subjects will recieve DEXA scans at study entry, week 48 and week 96. Subjects will receive DEXA scans if they need to switch anti-HIV regimens during the course of the study or if they discontinue the study prematurely.