McKinney R E, Johnson G M, Stanley K, Yong F H, Keller A, O'Donnell K J, Brouwers P, Mitchell W G, Yogev R, Wara D W, Wiznia A, Mofenson L, McNamara J, Spector S A
Department of Pediatrics and Psychiatry, Duke University Medical Center, Durham, North Carolina 27710, USA.
J Pediatr. 1998 Oct;133(4):500-8. doi: 10.1016/s0022-3476(98)70057-5.
The Pediatric AIDS Clinical Trials Group (PACTG) Protocol 300 assessed the clinical efficacy and safety of combination zidovudine/lamivudine (ZDV/3TC) compared with either didanosine (ddI) alone or combination ZDV/ddI.
Children with symptomatic human immunodeficiency virus (HIV) infection, 6 weeks through 15 years of age, were stratified according to age and randomly assigned to receive ddI, ZDV/3TC, or ZDV/ddI. The primary endpoint was time to first progression of HIV disease or death. Enrollment in the ZDV/ddI arm stopped after 11 months on the basis of results of PACTG Protocol 152, but blinded follow-up continued.
For the 471 children who could be evaluated, the median age was 2.7 years, median CD4 cell count was 699 cells/mm3, and median log10 HIV RNA was 5.1/mL. Median follow-up was 9.4 months. Patients receiving ZDV/3TC had a lower risk of HIV disease progression or death than those receiving ddI alone (15 vs 38 failures, P = .0006) and a lower risk of death (3 vs 15 deaths, P = .0039). Weight and height growth rates, CD4+ cell counts, and RNA concentrations showed results favoring ZDV/3TC. For patients concurrently randomized to all 3 treatment arms, both ZDV/3TC and ZDV/ddI recipients had lower risk of HIV disease progression than those who received ddI alone (P = .0026 and P = .0045).
Combination therapy with either ZDV/3TC or ZDV/ddI was superior, as determined by clinical and laboratory measures, to monotherapy with ddI.
儿科艾滋病临床试验组（PACTG）300号方案评估了齐多夫定/拉米夫定联合用药（ZDV/3TC）与单独使用去羟肌苷（ddI）或ZDV/ddI联合用药相比的临床疗效和安全性。
对年龄在6周龄至15岁、有症状的人类免疫缺陷病毒（HIV）感染儿童，按年龄分层并随机分配接受ddI、ZDV/3TC或ZDV/ddI治疗。主要终点是HIV疾病首次进展或死亡的时间。基于PACTG 152号方案的结果，ZDV/ddI组的入组在11个月后停止，但盲法随访仍继续。
对于471名可评估的儿童，中位年龄为2.7岁，中位CD4细胞计数为699个/mm³，中位log10 HIV RNA为5.1/mL。中位随访时间为9.4个月。接受ZDV/3TC治疗的患者发生HIV疾病进展或死亡的风险低于单独接受ddI治疗的患者（失败例数分别为15例和38例，P = 0.0006），死亡风险也较低（死亡例数分别为3例和15例，P = 0.0039）。体重和身高增长率、CD4⁺细胞计数以及RNA浓度的结果均显示ZDV/3TC更具优势。对于同时随机分配至所有3个治疗组的患者，接受ZDV/3TC和ZDV/ddI治疗的患者发生HIV疾病进展的风险均低于单独接受ddI治疗的患者（P = 0.0026和P = 0.0045）。
通过临床和实验室指标判定，ZDV/3TC或ZDV/ddI联合治疗优于ddI单药治疗。
