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

ACTG 356是一项三部分、I/II期开放标签研究，在垂直HIV感染婴儿和15天至3岁儿童中评价三种不同的抗逆转录病毒联合方案（每种方案含有3或4种抗逆转录病毒药物）。 评价的药物组合为：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; 3）司他夫定/拉米夫定/奈韦拉平/奈非那韦。 评估包括HIV-1和CD 4/CD 8 T细胞动力学、活化和成熟。这项研究还测试了早期治疗（即在<3个月大时开始治疗）与有效的联合抗逆转录病毒治疗将允许长期控制病毒复制，保持正常的免疫功能的概念。 本研究已完成入组。 对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耐受的;没有初步的疗效数据。

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.