一项关于缩短齐多夫定治疗方案以预防母婴传播1型人类免疫缺陷病毒的试验。围产期HIV预防试验（泰国）研究者。

A trial of shortened zidovudine regimens to prevent mother-to-child transmission of human immunodeficiency virus type 1. Perinatal HIV Prevention Trial (Thailand) Investigators.

作者信息

Lallemant M, Jourdain G, Le Coeur S, Kim S, Koetsawang S, Comeau A M, Phoolcharoen W, Essex M, McIntosh K, Vithayasai V

机构信息

Epidémiologie Clinique, Santé Maternelle et Infantile et Sida, Institut de Recherche pour le Développement, Paris.

出版信息

N Engl J Med. 2000 Oct 5;343(14):982-91. doi: 10.1056/NEJM200010053431401.

DOI:10.1056/NEJM200010053431401

PMID:11018164

Abstract

BACKGROUND

The optimal duration of zidovudine administration to prevent perinatal transmission of human immunodeficiency virus type 1 (HIV-1) should be determined to facilitate its use in areas where resources are limited.

METHODS

We conducted a randomized, double-blind equivalence trial of zidovudine starting in the mother at 28 weeks' gestation, with 6 weeks of treatment in the infant (the long-long regimen), which is similar to protocol 076; zidovudine starting at 35 weeks' gestation, with 3 days of treatment in the infant (the short-short regimen); a long-short regimen; and a short-long regimen. The mothers received zidovudine orally during labor. The infants were fed formula and were tested for HIV DNA at 1, 45, 120, and 180 days. After the first interim analysis, the short-short regimen was stopped.

RESULTS

A total of 1437 women were enrolled. At the first interim analysis, the rates of HIV transmission were 4.1 percent for the long-long regimen and 10.5 percent for the short-short regimen (P=0.004). For the entire study period, the transmission rates were 6.5 percent (95 percent confidence interval, 4.1 to 8.9 percent) for the long-long regimen, 4.7 percent (95 percent confidence interval, 2.4 to 7.0 percent) for the long-short regimen, and 8.6 percent (95 percent confidence interval, 5.6 to 11.6 percent) for the short-long regimen. The rate of in utero transmission was significantly higher with the two regimens with shorter maternal treatment (5.1 percent) than with the two with longer maternal treatment (1.6 percent).

CONCLUSIONS

The short-short zidovudine regimen is inferior to the long-long regimen and leads to a higher rate of perinatal HIV transmission. The long-short, short-long, and long-long regimens had equivalent efficacy. However, the higher rate of in utero transmission with the short-long regimen suggests that longer treatment of the infant cannot substitute for longer treatment of the mother.

摘要

背景

应确定齐多夫定预防人类免疫缺陷病毒1型（HIV-1）围产期传播的最佳给药持续时间，以促进其在资源有限地区的使用。

方法

我们进行了一项随机、双盲等效性试验，齐多夫定在母亲妊娠28周时开始使用，婴儿接受6周治疗（长长方案），这与方案076相似；齐多夫定在妊娠35周时开始使用，婴儿接受3天治疗（短短方案）；长短方案；以及短长方案。母亲在分娩期间口服齐多夫定。婴儿采用配方奶喂养，并在1、45、120和180天时进行HIV DNA检测。在首次中期分析后，短短方案被停止。

结果

共纳入1437名女性。在首次中期分析时，长长方案的HIV传播率为4.1%，短短方案为10.5%（P=0.004）。在整个研究期间，长长方案的传播率为6.5%（95%置信区间为4.1%至8.9%），长短方案为4.7%（95%置信区间为2.4%至7.0%），短长方案为8.6%（95%置信区间为5.6%至11.6%）。母亲治疗时间较短的两种方案的宫内传播率（5.1%）显著高于母亲治疗时间较长的两种方案（1.6%）。