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

该方案正在研究感染HIV-1的婴儿和儿童的不同抗逆转录病毒药物方案。研究对象是那些到诊所接受感染评估的人。药物组合包括齐多夫定（AZT， ZDV）、二腺苷（ddI）、扎西他滨（ddC）、他夫定（d4T）、拉米夫定（3TC）、奈韦拉平（Virarume）、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。全国有200名儿童参加，地方有10名儿童参加。研究终点包括：a)缺乏病毒载量抑制（RNA PCR），即< 0.75;b)治疗安全性；c)研究药物组合的药代动力学（PK）性能。次要终点包括HIV RNA变化的特异性特征（斜率、最低点、AUC等）、CD4变化、体重变化、人群PK和生存比较。

This protocol is investigating different antiretroviral drug regimens in infants and children with HIV-1 infection. Study subjects are those who present to clinic for evaluation of the infection. The drug combinations include 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 10 children locally. 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.