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 study hypothesizes preventing high-level T-cell activation during acute HIV infection will reduce the level of integrated HIV provirus. The primary objective is to reduce T-cell activation. The secondary objectives are to determine if reduced T-cell activation will prevent CD4 loss during acute HIV infection and to demonstrate the safety of cyclosporine A (CsA) during primary HIV infection. This is a multicenter phase II study of 50 subjects undergoing primary HIV infection with treatment randomized in a 2:1 fashion to Trizivir, Kaletra and CsA for the first 4 weeks followed by 44 weeks without CsA versus patients treated with the same antiretrovirals without CsA. CsA will be given 0.3 mg/kg orally twice a day for 4 weeks, with the dose reduced for toxicity and raised in relation to trough levels. Intention-to-treat analysis measuring proviral DNA will be done at baseline, weeks 12, 24, and 48. T-cell and HIV plasma RNA levels will also be measured. Pilot studies have suggested tolerance to combinations and elevated CD4 and T-cell counts that persisted. Information from this study may result in standardization of care of the individual with primary HIV infection.
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