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

一项在1、2或3期ADC受试者中单独或与抗逆转录病毒方案同时口服美金刚的试验。美金刚的起始剂量为10 mg/天;剂量将每周增加10 mg/天，最大剂量为40 mg/天（TID）或最大耐受剂量。受试者必须在至少6周内未接受抗逆转录病毒治疗，或在进入研究前至少连续6周接受过FDA批准的抗逆转录病毒治疗（例如核苷、蛋白酶抑制剂）的稳定治疗（单独或联合治疗）。将要求受试者在主要评价期内维持其并行抗逆转录病毒治疗方案，持续16周。16周评价期后，在重新评估前将进行4周洗脱期。然后，所有成功完成16周治疗的受试者（包括之前接受安慰剂的受试者）将重新递增至其MTB或40 mg/天剂量。本研究设计严格遵循ACTG 162，其统计部分基于ACTG 162，ACTG 162是一项成功完成的高剂量或低剂量尼莫地平治疗AIDS痴呆综合征的I/II期研究。(ACTG（第301条）

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)