ACTG A5095

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。本研究将比较三种蛋白酶抑制剂（PI）保留治疗方案用于HIV-1感染的初始治疗。治疗的目标是抑制和维持HIV-1 RNA水平< 200拷贝/ml。本研究还将确定三种PI保留方案的安全性和耐受性。1.假设本研究将评估三个主要疗效假设。假设一：何：ABC/3 TC/ZDV组的病毒学失败率大于3 TC/ZDV/EFV组的病毒学失败率。H1：ABC/3 TC/ZDV组的病毒学失败率不劣于3 TC/ZDV/EFV组的病毒学失败率。注：本试验将不评估ABC/3 TC/ZDV组的病毒学失败率是否低于3 TC/ZDV/EFV组。假设II：Ho：ABC/3 TC/ZDV/EFV组和3 TC/ZDV/EFV组的至病毒学失败时间分布无差异。H1：ABC/3 TC/ZDV/EFV和3 TC/ZDV/EFV组中至病毒学失败时间的分布存在差异。假设III：Ho：ABC/3 TC/ZDV/EFV组和ABC/3 TC/ZDV组的至病毒学失败时间分布无差异。H1：ABC/3 TC/ZDV/EFV和ABC/3 TC/ZDV组中至病毒学失败时间的分布存在差异。2.具体目标A5095：本研究的主要目的是：1）比较三种初始PI保留抗逆转录病毒方案抑制和维持HIV-1 RNA <200拷贝/mL（失败时间）的能力。2)确定三种初始PI保留方案的安全性和耐受性。A5097：本研究的主要目的是：1）描述与无EFV治疗相比，EFV治疗启动相关的神经系统症状和体征的发生率、持续时间和认知运动效应。2)将这些结果与治疗前24周的EFV血清药物水平相关联。 A5107：本研究的主要目的是：1）描述BMS-232632在25例HIV阳性受试者中的吸收和分布特征。2)在既往非含PI方案失败的患者中研究BMS-232632的浓度-效应关系。3)探索血浆BMS-232632药代动力学参数与胆红素变化之间的关系。

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 study will compare three protease inhibitor (PI) -sparing treatment options for the initial treatment of HIV-1 infection. The goal of therapy will be to suppress and maintain HIV-1 RNA levels < 200 copies/ml. This study would also determine the safety and tolerability of the three PI-sparing regimens. 1. Hypothesis Three primary efficacy hypotheses will be evaluated in this study. Hypothesis I: Ho: The rate of virologic failure in the ABC/3TC/ZDV arm is greater than the rate of virologic failure in the 3TC/ZDV/EFV arm. H1: The rate of virologic failure in the ABC/3TC/ZDV is not inferior to the rate of virologic failure in the 3TC/ZDV/EFV arm. NOTE: This trial will not evaluate whether there is a lower rate of virologic failure in the ABC/3TC/ZDV compared to the 3TC/ZDV/EFV arm. Hypothesis II: Ho:There is no difference in the distribution of time to virologic failure in the ABC/3TC/ZDV/EFV and the 3TC/ZDV/EFV arms. H1: There is a difference in the distribution of time to virologic failure in the ABC/3TC/ZDV/EFV and the 3TC/ZDV/EFV arms. Hypothesis III: Ho: here is no difference in the distribution of time to virologic failure in the ABC/3TC/ZDV/EFV and the ABC/3TC/ZDV arms. H1: There is a difference in the distribution of time to virologic failure in the ABC/3TC/ZDV/EFV and the ABC/3TC/ZDV arms. 2. Specific Aims A5095: The primary objectives of this study are to 1) to compare the ability of the three initial PI-sparing antiretroviral regimens to suppress and maintain HIV-1 RNA <200 copies/mL (time to failure). 2) To determine the safety and tolerability of the three initial PI-sparing regimens. A5097: The primary objectives of this study are to 1)To describe the incidence, duration, and cognitive motor effect of neurologic symptoms and signs associated with initiation of EFV therapy compared to therapy without EFV. 2) To correlate these findings with EFV serum drug levels over the initial 24 weeks of treatment. A5107: The primary objectives of this study are to 1) To describe the absorption and disposition characteristics of BMS-232632 in 25 HIV-positive subjects. 2) To investigate concentration-response relationships of BMS-232632 in patients who have previously failed non-PI-containing regimens. 3) To explore relationships between plasma BMS-232632 pharmacokinetic parameters and changes in bilirubin.