ACTG 076--ORAL ZIDOVUDINE IN PREGNANT HIV INFECTED WOMEN AND THEIR INFANTS

ACTG 076--艾滋病毒感染孕妇及其婴儿口服齐多夫定

• 批准号: 5224072
• 负责人: MARILYN G DOYLE
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/5224072
• 关键词: AIDS therapy; HIV infections; chemoprevention; clinical research; clinical trials; communicable disease control; drug screening /evaluation; female; human pregnant subject; human subject; human therapy evaluation; intravenous administration; microorganism disease chemotherapy; newborn human (0-6 weeks); oral administration; pediatric AIDS; pregnancy; vertical transmission; zidovudine

This was a multicenter study designed to determine whether the vertical transmission of HIV can be interrupted by continuous oral zidovudine (ZDV) administration to HIV infected pregnant women beginning at 14 to 34 weeks of gestation, an intravenous intrapartum infusion, and oral ZDV administration to their infants from birth to six weeks of age. This study also evaluated the safety of zidovudine for both the pregnant woman and the newborn infant. From April 1991 through December 20, 1993, the cutoff date for the first interim analysis of efficacy, 477 pregnant women were enrolled. During the study period, 409 gave birth to 415 live-born infants. HIV infection status was known for 363 births (180 in the ZDV group and 183 in the placebo group). Thirteen infants in the ZDV group and 40 in the placebo group were HIV infected. The proportions infected at 18 months were 8.3% in the ZDV group and 25.5% in the placebo group. In conclusion, in pregnant women with mildly symptomatic HIV disease and no prior treatment with antiretroviral drugs during the pregnancy, a regimen consisting of ZDV given ante-partum and intra partum to the mother and to the newborn for six weeks can reduce the risk of maternal-infant transmission by approximately two thirds. Based on the above results, the study was closed to further enrollment February 18, 1994.

这是一项多中心研究，旨在确定垂直 持续口服齐多夫定可阻断HIV的传播 (ZDV)从14至14岁开始对感染艾滋病毒的孕妇进行接种 妊娠34周，产后静脉输液，口服ZDV 他们的婴儿从出生到六周大的时候给药。这 研究还评估了齐多夫定对两名孕妇的安全性 和新生婴儿。从1991年4月到1993年12月20日， 首次疗效中期分析截止日期，477例孕妇 女性被录取。在研究期间，409只产下了415只 活产婴儿。已知有363名新生儿(180名)感染艾滋病毒 在ZDV组和183在安慰剂组)。医院里有13个婴儿 ZDV组和安慰剂组有40人感染了HIV。比例 18个月时ZDV组感染率为8.3%，安慰剂组为25.5% 一群人。 总而言之，在患有轻微症状的艾滋病毒疾病和 在怀孕期间没有事先使用抗逆转录病毒药物治疗， 由ZDV产前和产后给药组成的方案 而给母亲和新生儿服用六周可降低患病风险 母婴传播率约为三分之二。基于 以上结果，该研究于2月18日停止了进一步的招募， 1994年。