ACTG A5095

ACTG A5095

• 批准号: 7378806
• 负责人: ADRIANA S.A. ANDRADE
• 金额: $ 0.47万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378806
• 关键词: ACTG; A5095

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.

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。本研究将比较三种蛋白酶抑制剂（PI）节约治疗方案用于HIV-1感染的初始治疗。治疗的目标将是抑制和维持HIV-1 RNA水平< 200拷贝/ml。该研究还将确定三种pi保留方案的安全性和耐受性。1. 本研究将评估三个主要的疗效假设。假设1:Ho: ABC/3TC/ZDV组的病毒学失败率大于3TC/ZDV/EFV组的病毒学失败率。H1: ABC/3TC/ZDV组的病毒学失败率并不低于3TC/ZDV/EFV组的病毒学失败率。注：本试验不会评估ABC/3TC/ZDV组是否比3TC/ZDV/EFV组的病毒学失败率更低。假设二：Ho：在ABC/3TC/ZDV/EFV和3TC/ZDV/EFV中，病毒学失败的时间分布没有差异。H1: ABC/3TC/ZDV/EFV毒株和3TC/ZDV/EFV毒株病毒学失败的时间分布存在差异。假设III: Ho：在ABC/3TC/ZDV/EFV和ABC/3TC/ZDV中，到病毒学失败的时间分布没有差异。H1: ABC/3TC/ZDV/EFV毒株和ABC/3TC/ZDV毒株病毒学失败的时间分布存在差异。2. 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（失效时间）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)描述与非EFV治疗相比，EFV治疗开始时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)将这些发现与治疗最初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25名hiv阳性受试者BMS-232632的吸收和处置特征。2)探讨BMS-232632在非含pi方案治疗失败患者中的浓度-反应关系。3)探讨血浆BMS-232632药动学参数与胆红素变化的关系。