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: 6445211
• 负责人: RICHARD W. PRICE
• 金额: $ 14.03万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-05-01 至 2002-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6445211
• 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.

本项目将评估抗逆转录病毒治疗对 艾滋病痴呆综合征（ADC）的发展和进展 大规模III期ACTG临床试验的背景下。 的 将神经学数据收集纳入大型治疗试验 提供了评价治疗效果的机会， ADC的防治。 互补战略 简单（微观）和更广泛（宏观）的神经学评价是 在ACTG第193号协议的背景下描述， 旨在评估抗逆转录病毒治疗在一个非常 HIV-1感染者的困难群体患有晚期 疾病少于50 CD 4 + T淋巴细胞/立方毫米和6个月 既往核苷治疗。 ACTG方案193是一个三臂随机， 双盲研究旨在确定两种药物的相对疗效 核苷类抗逆转录病毒联合治疗方案和一种治疗方案 每月替代核苷治疗 的主要终点 ACTG 193是生存。 然而，微神经学评价是一项 所有受试者方案评估的内在部分，以及MACRO 神经学评估是三个专门的子研究之一， 这个协议。 本项目提出的总体战略 （将所有受试者的MICRO神经学评价与 选定的艾滋病临床试验单位（ACTU）的受试者子集）将 提供了一种获得适度但功能重要的神经系统的方法， 从具有必要专业知识的ACTU子集获得的数据。 这 这种方法已经在其他ACTG中以有限的方式成功地进行了测试 协议. 因此，本项目寻求（1）评估治疗效果 关于主要ACTG治疗试验中的ADC结局，以及（2） 继续完善ADC的神经系统评估方法， 微观和宏观研究。