HIV INFECTED SUBJECTS COMPARING TENOFOVIR DISOPROXIL FUMARATE AND EMTRICITABINE

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。本研究的目的是比较替诺福韦DF和恩曲他滨的简化给药方案与复方韦加依非韦伦治疗hiv -1感染抗逆转录病毒的初始受试者。已经证明，Combivir和Efavirenz是一种特别有效的初始方案。因此，本研究将比较替诺福韦DF、恩曲他滨和依非韦伦与复方比韦和依非韦伦。该研究还将比较替诺福韦DF和恩曲他滨联合Efavirenz与Combivir和Efavirenz的安全性。使用全身DEXA进行形态学评估，试图确定NRTI在脂肪营养不良发展中的作用。主要目的：评估替诺福韦DF和恩曲他滨联合依非韦伦相对于复方比韦联合依非韦伦治疗HIV-1感染ART-naive受试者的非效性，通过在48周内实现和维持确认HIV RNA < 400拷贝/mL来确定。

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.