NEUROLOGICAL EVALUATION OF THE AIDS DEMENTIA COMPLEX IN ACTG CLINICAL TRIALS

该项目将评估抗逆转录病毒治疗的效果 艾滋病痴呆复合体(ADC)的发生发展 大规模ACTG第三阶段临床试验的背景。这个 在大型治疗试验中纳入神经学数据收集 为评估以下方面的治疗效果提供机会 ADC的预防和治疗。互补性战略 简要(微观)和更广泛(宏观)的神经学评估是 在ACTG协议193的上下文中描述的，该ACTG协议是一种“打捞”协议 旨在评估抗逆转录病毒治疗的疗效 晚期HIV-1感染者疑难群体 每立方毫米低于50个CD4T淋巴细胞的疾病，以及6个月的 之前接受过核苷治疗。ACTG协议193是三臂随机的， 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与A方案 每月另类核苷疗法。的主端点 ACTG 193代表生存。然而，微观神经学评估是一种 针对所有受试者的协议评估的固有部分，以及宏观 神经学评估是相关的三个专门子研究之一。 使用这一协议。本项目提出的总体战略 (将对所有受试者的微观神经学评估与 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显著的神经学的方法 从具有必要专业知识的ACTU的子集获得的数据。这 该方法已在其他ACTG中以有限的方式成功测试 协议。因此，本项目寻求(1)评估治疗效果 关于主要ACTG治疗试验的ADC结果，以及(2) 继续完善ADC的神经学评估方法 微观和宏观研究的背景。

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.