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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项为期96周的两步随机开放研究，研究了在HIV-1感染早期但非急性感染期间进行36周有效抗逆转录病毒治疗对病毒学临界点的影响。150名最近感染HIV-1的患者将以1：1的方式随机进入第一步，接受36周的替诺福韦DF、恩曲他滨和洛比那韦/利托那韦治疗，而不接受治疗。任何没有接受治疗的受试者，如果符合临床、病毒学或免疫学标准，按照方案规范开始治疗，将得到咨询并提供治疗，进入研究的第二步。步骤2是在随机接受治疗的受试者中重新开始抗逆转录病毒治疗，这些受试者已经完成了36周的疗程或过早停止了治疗，现在符合重新开始治疗的研究标准；或者是在随机进入时没有接受治疗的受试者中开始抗逆转录病毒治疗，这些受试者现在符合开始治疗的研究标准。受试者将接受体检、血液和尿液测试以及遵守情况评估。

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.