A5142:COMPARISON OF TREATMENT FOR INITIAL THERAPY OF HIV INFECTION

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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. ACTG A5142- This is a Phase III, randomized, three arm, open-label study comparing three different anti-HIV drug regimens as first-time treatments for HIV infection. The study will look at the effectiveness and safety of the three drug regimens and how well these regimens are tolerated. 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 from the arms and legs, or increased fat in other parts of the body such as the upper back and abdomen. Therefore, the study will also look at the effect of these three HIV regimens on changes in metabolism. The anti-HIV drugs to be used in this study are lopinavir/ritonavir (LPV/RTV), efavirenz (EFV), zidovudine (ZDV), lamivudine (3TC), Combivir (the combination of ZDV and 3TC in a single tablet), stavudine extended release (d4T XR), and tenofovir (TDF). All of these drugs have been approved by the U. S. Food and Drug Administration (FDA) for the treatment of HIV infection. Studies have shown that these drugs are effective against HIV infection when used with each other. However, there is not much information available on the combination of EFV and LPV/RTV, which is one of the regimens being studied in this protocol. Subjects will be stratified at randomization by screening plasma HIV-1 RNA, chronic hepatitis infection and selection of NRTI. Subjects will receive treatment for 96 weeks after the last subject is enrolled. Subjects will have anthropometic measurements, several blood test, urinalysis, pregnancy test and Dexa scans.