A RANDOMIZED STUDY OF TREATMENT WITH TENOFOVIR DF, EMTRICITABINE, AND LOPINAVIR

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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 two-step, 96-week randomized, open-label study of the effects on the virologic setpoint of 36 weeks of potent antiretroviral therapy administered during early but not acute HIV-1 infection. One hundred fifty recently HIV-1 infected subjects will be randomized to Step 1 in a 1:1 fashion to receive 36 weeks of tenofovir DF, emtricitabine, and lopinavir/ritonavir versus no treatment. Any subject not on treatment who meets clinical, virologic or immunologic criteria for treatment initiation as per protocol specifications will be counseled and offered treatment and entry into Step 2 of the study. Step 2 is the re-initiation of antiretroviral therapy in subjects randomized to treatment who have completed the 36-week course of treatment or have discontinued treatment prematurely and now meet study criteria for treatment re-initiation; or initiation of antiretroviral therapy in subjects randomized to no treatment at entry who now meet study criteria for treatment initiation. Subjects will undergo physical exams, blood and urine testing, and adherence evaluations.