NEUROLOGICAL EVALUATION OF THE AIDS DEMENTIA COMPLEX IN ACTG CLINICAL TRIALS

ACTG 临床试验中艾滋病痴呆症的神经学评估

• 批准号: 6112479
• 负责人: RICHARD W. PRICE
• 金额: $ 27.36万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-05-01 至 2000-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6112479
• 关键词: 2'3' dideoxyinosine; AIDS dementia complex; AIDS therapy; HIV infections; clinical trials; combination chemotherapy; human immunodeficiency virus 1; human subject; human therapy evaluation; nervous system disorder chemotherapy; neuropsychological tests; nucleosides; zidovudine

This project will evaluate the effect of antiretroviral therapy of the development and progression of the AIDS dementia complex (ADC) in the context of large-scale, Phase III ACTG clinical trials. The incorporation of neurological data collection in large treatment trials provides the opportunity to evaluate treatment effects with respect to preventions as well as therapy of ADC. The strategy of complementary brief (MICRO) and more extended (MACRO) neurological evaluations is described in the context of ACTG Protocol 193, a 'salvage' protocol designed to assess efficacy of antiretroviral treatment in a very difficult group of HIV-1-infected subjects suffering from late-stage disease with less that 50 CD4+ T-lymphocytes per cu.mm and 6 months of prior nucleoside therapy. ACTG Protocol 193 is a three-arm randomized, double-blind study designed to determine the relative efficacy of two regimens of combination nucleoside antiretroviral therapy and a regimen of monthly alternative nucleoside therapy. The principal endpoint of ACTG 193 is survival. However, the MICRO neurological evaluation is an intrinsic part of the protocol assessment for all subjects, and the MACRO neurological evaluation is one of three specialized substudies associated with this protocol. The overall strategy proposed in this project (combining the MICRO neurological evaluation on all subjects with a subset of subjects at selected AIDS Clinical Trial Units (ACTU's)) will provide a way to obtain modest but functionally significant neurological data obtained from a subset of ACTU's with requisite expertise. This approach has been successfully tested in limited fashion in other ACTG protocols. Thus, this project seeks (1) to assesses treatment efficacy with respect to ADC outcome in major ACTG treatment trials, and (2) to continue to refine neurological assessment methodology for ADC in the context of MICRO and MACRO studies.

该项目将评估抗逆转录病毒疗法的影响 艾滋病痴呆症复合物（ADC）的发展和发展 大规模，III阶段ACTG临床试验的背景。 这 在大型治疗试验中纳入神经数据收集 提供了评估治疗效果的机会 预防以及ADC的治疗。 补充策略 简短（微）和更多扩展（宏）神经系统评估是 在ACTG协议193的背景下描述了“打捞”协议 旨在评估抗逆转录病毒治疗的功效 患有晚期的HIV-1感染受试者的困难小组 每立方米的疾病较少50+ T淋巴细胞和6个月的疾病 先前的核苷治疗。 ACTG协议193是一个三臂随机的， 双盲研究旨在确定两个 组合核苷抗逆转录病毒疗法的方案和治疗方案 每月替代核苷治疗。 主要终点 ACTG 193是生存。 但是，微神经学评估是 所有受试者的协议评估的内在部分和宏 神经学评估是相关的三个专业取代物之一 使用此协议。 该项目提出的总体策略 （将所有受试者的微神经学评估与A结合 选定AIDS临床试验单元（ACTU）的受试者子集将 提供一种获得适中但功能意义的神经系统的方法 从ACTU的子集获得的数据具有必要的专业知识。 这 在其他ACTG中以有限的方式成功测试了方法 协议。 因此，该项目寻求（1）评估治疗功效 关于主要ACTG治疗试验中的ADC结果，（2） 继续完善ADC的神经学评估方法 微观和宏观研究的背景。