CLINICAL TRIAL: A PHASE III COMPARATIVE STUDY OF THREE NON-NUCLEOSIDE REVERSE TR

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。 这项研究和小组研究的目的是： 1-看看不同的抗艾滋病毒药物组合在降低从未接受过抗艾滋病毒治疗的人的血液中艾滋病毒数量(病毒载量)方面的效果如何。 2-评估本研究中使用的三种抗HIV治疗的安全性和耐受性。 3-了解接受A5257中三种抗艾滋病毒治疗之一的参与者的代谢变化，这是他们的第一个抗逆转录病毒方案。我们将测量的代谢变化包括身体脂肪、骨骼、血管、血糖、胆固醇和肾脏功能。 符合条件的受试者将随机接受三种抗艾滋病毒治疗之一： 1)阿扎那韦(ATV)和利托那韦(RTV)联合替诺福韦(TDF)和恩曲他滨(FTC) 2)雷替格列韦(Ral)、替诺福韦(TDF)和恩曲他滨(FTC) 达鲁那韦(DRV)联合利托那韦(RTV)联合替诺福韦(TDF)和恩曲他滨(FTC) 目前的治疗指南建议，未接受治疗的艾滋病毒感染患者应采用三联药物方案治疗，其中包括两种核苷逆转录酶抑制剂(NRTI)和法韦林(EFV)或三种增强型蛋白酶抑制剂(PI)中的一种。然而，由于副作用、致畸性、药代动力学(PK)相互作用或获得性NNRTI耐药病毒，有些患者不希望使用含有EFV的方案进行治疗。 对于这些人群，需要替代方案，而文献中缺乏对可能的NNRTI保留方案之间的差异的更彻底的了解。

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 the study and substudy is: 1- To see how well different combinations of anti-HIV drugs work to decrease the amount of HIV in the blood (viral load) of people who have never received anti-HIV therapy. 2- To evaluate the safety and tolerability of the three anti-HIV treatments used in this study. 3- To learn about the metabolic changes in participants receiving one of the three anti-HIV treatments given in A5257 as their first antiretroviral regimen. The metabolic changes we will be measuring are in body fat, bone, the blood vessels, blood sugar, cholesterol, and kidney function. Eligible subjects will be randomized to receive one of the three anti-HIV treatments: 1) Atazanavir (ATV) and ritonavir (RTV) with tenofovir (TDF) and emtricitabine (FTC) 2) Raltegravir (RAL) with tenofovir (TDF) and emtricitabine(FTC) 3) Darunavir (DRV) with ritonavir (RTV) with tenofovir (TDF) and emtricitabine (FTC) The current treatment guidelines recommend that treatment-na¿¿ve, HIV-infected patients be treated with a triple drug regimen that includes two Nucleoside reverse transcriptase inhibitors (NRTIs) and either efavirenz (EFV) or one of three boosted Protease inhibitors (PIs). However, there are patients for whom treatment with an EFV-containing regimen is undesirable due to side effects, teratogenicity, pharmacokinetic (PK) interactions, or acquired NNRTI-resistant virus. Alternative regimens are needed for these populations, and a more thorough understanding of the differences between possible NNRTI-sparing regimens is missing from the literature.