ACTG366:PHASEI & II MASTER PROT OF NOVEL ANTIRETROVIRAL COMBINATION T

这是一项为期52周的研究，研究对象是晚期HIV感染儿童及其对联合用药的反应，联合用药包括齐多夫定（AZT，ZDV）、去羟肌苷（ddI）、扎西他滨（ddC）、司他夫定（d4T）、拉米夫定（3TC）、奈韦拉平（Viraravine）、利托那韦（Norvir）和奈非那韦（Viracept）。 除奈韦拉平和ddC外，所有药物都已被FDA批准用于儿童。全国将有200名儿童参加，地方将有8名儿童参加。药物服用52周，如果耐受，患者可以选择额外的48周治疗。 a）缺乏病毒载量抑制（RNA PCR），即，< 0.75，B）治疗安全性，和c）研究药物组合的药代动力学（PK）性能。次要终点包括研究HIV RNA变化的特定特征（斜率、最低点、AUC等），CD 4变化、体重变化、群体PK和生存期比较。

This is a 52-week study of children with advanced HIV infection and their response to drug combinations, including zidovudine (AZT, ZDV), didanosine (ddI), zalcitabine (ddC), stavudine (d4T), lamivudine (3TC), nevirapine (Virarume), ritonavir (Norvir), and nelfinavir (Viracept). All drugs except nevirapine and ddC have been FDA approved for use in children. Two hundred children will participate nationwide and 8 children locally. Drugs are taken for 52 weeks, and if tolerated, patients are offered an option for an additional 48 weeks of therapy. Study endpoints include: a) lack of viral load suppression (RNA PCR), i.e., < 0.75, b) treatment safety, and c) performance of pharmacokinetics (PK) of study drug combinations. Secondary endpoints include study of specific characteristics of HIV RNA changes (slope, nadir, AUC, etc.), CD4 change, weight change, population PK and survival comparisons.