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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究和子研究的目的是： 1-了解不同的抗HIV药物组合如何有效降低从未接受过抗HIV治疗的人血液中的HIV数量（病毒载量）。 2-评价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HIV治疗之一作为首次抗逆转录病毒治疗方案的受试者的代谢变化。我们将测量的代谢变化是身体脂肪，骨骼，血管，血糖，胆固醇和肾功能。 合格受试者将随机接受三种抗HIV治疗之一： 1)阿扎那韦（ATV）和利托那韦（RTV）与替诺福韦（TDF）和恩曲他滨（FTC） 2)雷特格韦（RAL）与替诺福韦（TDF）和恩曲他滨（FTC） 3)达芦那韦（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初治的HIV感染患者使用三联药物方案治疗，包括两种核苷逆转录酶抑制剂（NRTI）和依法韦仑（EFV）或三种增强的蛋白酶抑制剂（PI）之一。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，有些患者不希望接受含EFV方案的治疗。 这些人群需要替代方案，文献中缺少对可能的NNRTI保留方案之间差异的更全面了解。

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.