Single-dose perinatal nevirapine plus standard zidovudine to prevent mother-to-child transmission of HIV-1 in Thailand
Single-dose perinatal nevirapine plus standard zidovudine to prevent mother-to-child transmission of HIV-1 in Thailand
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DOI：
10.1056/nejmoa033500
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发表时间：
2004-07-15
影响因子：
158.5
通讯作者：
Thaineua, V
中科院分区：
文献类型：
--
作者：
Lallemant, M;Jourdain, G;Thaineua, V
背景：尽管齐多夫定预防性治疗可大幅降低 1 型人类免疫缺陷病毒 (HIV) 的传播率，但仍有大量婴儿受到感染。我们假设，除了齐多夫定外，在分娩期间给母亲和新生儿服用单剂量口服奈韦拉平将进一步减少艾滋病毒的传播。 方法：我们对在妊娠晚期接受齐多夫定治疗的泰国妇女进行了一项随机、双盲试验，试验了三种治疗方案。在一组中，母亲和婴儿接受单剂奈韦拉平（奈韦拉平-奈韦拉平方案）；在另一项研究中，母亲和婴儿分别接受奈韦拉平和安慰剂（奈韦拉平-安慰剂方案）；最后，母亲和婴儿接受安慰剂（安慰剂-安慰剂方案）。这些婴儿还接受了一周的齐多夫定治疗并采用配方奶喂养。该研究的终点是通过病毒学检测确定婴儿感染艾滋病毒。结果：2001年1月15日至2003年2月28日期间，共有1844名泰国妇女入组。在第一次中期分析中，独立数据监测委员会停止了安慰剂组的招募。在中期分析之前分娩的女性中，奈韦拉平-奈韦拉平组的传播率随机 Kaplan-Meier 估计为 1.1%（95% 置信区间，0.3 至 2.2），安慰剂组为 6.3%（95% 置信区间，3.8 至 8.9）（P
BACKGROUND:Although zidovudine prophylaxis decreases the rate of transmission of the human immunodeficiency virus (HIV) type 1 substantially, a large number of infants still become infected. We hypothesized that the administration, in addition to zidovudine, of a single dose of oral nevirapine to mothers during labor and to neonates would further reduce transmission of HIV.METHODS:We conducted a randomized, double-blind trial of three treatment regimens in Thai women who were receiving zidovudine therapy during the third trimester of pregnancy. In one group, mothers and infants received a single dose of nevirapine (nevirapine-nevirapine regimen); in another, mothers and infants received nevirapine and placebo, respectively (nevirapine-placebo regimen); and in the last, mothers and infants received placebo (placebo-placebo regimen). The infants also received one week of zidovudine therapy and were formula-fed. The end point of the study was infection with HIV in the infants, established by virologic testing.RESULTS:Between January 15, 2001, and February 28, 2003, a total of 1844 Thai women were enrolled. At the first interim analysis, the independent data monitoring committee stopped enrollment in the placebo-placebo group. Among women who delivered before the interim analysis, the as-randomized Kaplan-Meier estimates of the transmission rates were 1.1 percent (95 percent confidence interval, 0.3 to 2.2) in the nevirapine-nevirapine group and 6.3 percent (95 percent confidence interval, 3.8 to 8.9) in the placebo-placebo group (P