INFLUENCE OF RISK FOR DISEASE PROGRESSION ON RESPONSE TO ANTIRETROVIRAL THERAPY

这是一项随机、双盲的临床试验，受试者包括 较长的ZDV/ddi或ZDV/ddC联合治疗经验。 符合资格的受试者是ACTG 175的参与者，他们的剩余 ACTG患者最初分配的联合治疗直到随访结束 175，或交叉使用其中一种联合疗法(因为 CD4+细胞计数基线或主要疾病进展的50%界线 艾滋病毒相关疾病)。他们肯定也一直保持着这种组合 在数据收集结束之间的任何间隔期的治疗 ACTG 175(1995年2月28日)和加入ACTG 303。 受试者将被随机分配到三个治疗组中的一个：EITS至 继续他们的ZDV/ddi或ZDV/ddC，或向他们的ZDV/ddi添加3TC或 ZDV/ddC，或切换到ZDV/3TC。这项研究将部分地被蒙蔽 受试者将服用ddi或ddi安慰剂，或ddC或ddC安慰剂， 以及3TC安慰剂。主要的结果衡量标准是艾滋病毒核糖核酸的变化 复印号。研究治疗计划为48周。

This is a randomized, double-blind clinical trial involving subjects with prolonged prior experience with ZDV/ddI or ZDV/ddC combination therapies. Eligible subjects are participants in ACTG 175 who remanied of their initially assigned combination therapy until the end of follow-up in ACTG 175, or were crossed over to one of the combination therapies (because of a 50% deline for baseline in CD4+ cell count or the development of major HIV-related disease). They must also have remained on that combination therapy for any intervening period between the end of data collection for ACTG 175 (Feb 28,1995) and entry into ACTG 303. Subjects will be randomized to one of three treatment arms: eith to continue their ZDV/ddI or ZDV/ddC, or to add 3TC to their ZDV/ddI or ZDV/ddC, or to switch to ZDV/3TC. The study will be partially blinded in that subjects will take either ddI or ddI placebo, or ddC or ddC placebo, as well as 3TC placebo. The primary outcome measure is change in HIV RNA copy number. The duration of study treatment is planned to be 48 weeks.