HIV INFECTED SUBJECTS COMPARING TENOFOVIR DISOPROXIL FUMARATE AND EMTRICITABINE

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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. The purpose of this study is to compare the simplified dosing regimens of tenofovir DF and emtricitabine versus combivir plus efavirenz in the treatment of HIV-1-infected antiretroviral naive subjects. It has been demonstrated that Combivir and Efavirenz is a particularly effective initial regimen. Therefore this study will compare tenofovir DF, emtricitabine, and efavirenz versus Combivir and Efavirenz. The study will also compare the safety profile of tenofovir DF and emtricitabine in combination with Efavirenz versus Combivir and Efavirenz. Morphological assessment using whole body DEXA will be performed in an attempt to establish the role of NRTI's in the development of lipodystrophy. Primary objective: To assess non-inferiority of tenofovir DF and emtricitabine in combination with efavirenz relative to Combivir in combination with efavirenz in the treatment of HIV-1-infected ART-naive subjects as determined by the achievement and maintenance of confirmed HIV RNA < 400 copies/mL through week 48.