ACTG 301, TRIAL OF MEMANTINE FOR ADC AS TREATMENT W/ ANTIRETROVIRAL THERAPY

在ADC阶段1、2或3的受试者中单独或与抗逆转录病毒方案同时服用的口服美金刚的试验。美金胺的起始剂量为每天10毫克；每周每天增加10毫克，最大剂量为每天40毫克(以TID为基础)或最大耐受量。受试者必须至少6周没有抗逆转录病毒，或在进入研究之前至少连续6周单独或联合使用FDA批准的抗逆转录病毒疗法(如核苷、蛋白酶抑制剂)进行过稳定治疗。受试者将被要求在16周的初步评估期内保持他们同时服用的抗逆转录病毒方案。在16周的评估期之后，在重新评估之前将有4周的淘汰期。然后，所有成功完成16周治疗的受试者，包括以前接受安慰剂治疗的受试者，将重新升级到他们的MTB或40毫克/天的剂量。这项研究设计紧随ACTG 162，这是一项成功完成的大剂量或小剂量尼莫地平治疗艾滋病痴呆复合体的I/II期研究，统计部分基于这一设计。(ACTG 301)

A trial of oral Memantine taken alone or concurrently with an antiretroviral regimen in subjects with ADC stage 1, 2, or 3. The starting dose of Memantine will be 10mg/day; the dose will be increased by 10 mg/day every week to a maximum dose of 40 mg/day (on TID basis) or to maximum tolerated dose. Subjects must be antiretroviral free for at least 6 weeks, or have had prior stable treatment with FDA approved antiretroviral therapy (e.g. Nucleoside, protease inhibitor), alone or in combination, for at least 6 consecutive weeks prior to study entry. Subjects will be asked to maintain their concurrent antiretroviral regimen through out the primary evaluation period for 16 weeks. Following the 16 week evaluation period, there will be a 4 week washout prior to reassessment. Then all subjects successfully completing 16 weeks of therapy including those formerly receiving a placebo will be re-escalated to their MTB or the 40 mg/day dose. This study design closely follows, and the statistical portion is based on, ACTG 162, a successfully completed phase I/II study of high or low dose Nimodipine for AIDS Dementia Complex. (ACTG 301)