A5095: PHASE III, RANDOMIZED, DOUBLE-BLIND COMPARISON OF THREE PI-SPARING

A5095：三个 PI 保留的 III 期、随机、双盲比较

• 批准号: 7378389
• 负责人: ROY M. GULICK
• 金额: $ 0.5万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378389
• 关键词: A5095; PHASE; III; RANDOMIZED; DOUBLE

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. AIDS Clinical Trials Group Study A5095 is a phase III, multicenter, randomized, double-blind comparison of 3 HIV protease inhibitor-sparing regimens for the initial treatment of HIV infection. The 3 regimens are: (1) zidovudine/lamivudine/abacavir (co-formulated); (2) zidovudine/lamivudine (co-formulated) + efavirenz; and (3) zidovudine/lamivudine/abacavir (co-formulated) + efavirenz The specific primary objectives of this study are: to compare the ability of the three initial protease-inhibitor-sparing antiretroviral regimens to suppress and maintain HIV-1 RNA<200 copies/mL (time to virologic failure), and to determine the safety and tolerability of the three initial protease-inhibitor sparing regimens.

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。艾滋病临床试验小组研究A5095是一项III期、多中心、随机、双盲比较的3种HIV蛋白酶抑制剂保留方案用于HIV感染的初始治疗。这3种方案是：(1)齐多夫定/拉米夫定/阿巴卡韦(联合配方)；(2)齐多夫定/拉米夫定(联合配方)+依法韦林；以及(3)齐多夫定/拉米夫定/阿巴卡韦(联合配方)+依法韦林。这项研究的具体主要目标是：比较三种最初不使用蛋白酶抑制剂的抗逆转录病毒疗法抑制和维持HIV-1RNA和lt；200拷贝/毫升(病毒失效时间)的能力，并确定三种最初不使用蛋白酶抑制剂的抗逆转录病毒疗法的安全性和耐受性。