ACTG 356--ZDV/3TC/NEVIRAPINE COMBINTION THERAPY IN HIV INFANTS AND CHILDREN

ACTG 356是一项分三部分的I/II期开放标签研究，评估了三种不同的抗逆转录病毒组合方案(每种方案包含3或4种抗逆转录病毒药物)在15天至3岁的垂直艾滋病毒感染婴儿和儿童中的应用。接受评估的药物组合是：1)齐多夫定/拉米夫定/奈韦拉平；2)齐多夫定/司他夫定/奈韦拉平/阿巴卡韦；以及3)司他夫定/拉米夫定/奈韦拉平/奈非那韦。评估包括HIV-1和CD4/CD8 T细胞的动力学、激活和成熟。这项研究还测试了这样一个概念，即早期治疗(即在3个月大时开始治疗)有效的联合抗逆转录病毒疗法将允许长期控制病毒复制，同时保留正常的免疫功能。这项研究已经完成了应计。病人的治疗和随访应在2000年11月前完成。这些方案的毒性是可以容忍的；没有初步疗效数据可用。

ACTG 356 is a three part, phase I/II open-label study evaluating three different antiretroviral combination regimens (each containing 3 or 4 antiretrovirals) in vertically HIV-infected infants and children 15 days to 3 years of age. The drug combinations under evaluation are: 1)zidovudine/lamivudine/nevirapine; 2) zidovudine/stavudine/nevirapine/ abacavir; and 3) stavudine/lamivudine/nevirapine/nelfinavir. Evaluations include HIV-1 and CD4/CD8 T cell kinetics, activation and maturation. This study also tests the concept that early treatment (i.e. beginning therapy at < 3months of age) with potent, combination antiretroviral therapy will allow the long term control of viral replication with preservation of normal immune function. This study has completed accrual. Treatment and follow- up of patients should be completed by November 2000. Toxicity from these regimens has been tolerable; no preliminary efficacy data are available.