PREVENTION MATERNAL TO INFANT HIV TRANSMISSION IN INDIA

描述：(改编自申请者摘要)一项随机临床试验 提出了母婴传播艾滋病毒的建议，将直接比较 单用AZT联合AZT+3TC治疗1200名印度HIV感染妇女的疗效 在24个月内。此外，治疗时间长短的影响将 还需评估：超过40%的这一队列将在36周后登记 30%的孕妇将在临产时登记。本研究 还将比较产后产妇对病毒AZT的抵抗率和 两个治疗组母婴配对的发病率和死亡率。在……里面 此外，这项研究将描述促进女性 参与临床试验以协助未来的试验，以及 实施临床和行为艾滋病预防干预措施。这 研究将提供一个机会来确定和设计未来的干预措施， 并可以更快地将资源集中在产后的具体原因上 发展中国家母婴发病率和死亡率。

DESCRIPTION: (Adapted from applicant's abstract) A randomized clinical trial of maternal-fetal HIV transmission is proposed which will directly compare the efficacy of AZT alone with AZT + 3TC in 1200 HIV-infected Indian women enrolled over a period of 24 months. In addition, the effect of length of therapy will also be assessed: more than 40% of this cohort will be enrolled after 36 weeks of gestation and 30% will be enrolled when they present in labor. This study will also compare the rates of post-partum maternal viral AZT resistance and the morbidity and mortality of mother/infant pairs in the 2 treatment arms. In addition, this study will characterize factors that promote women's participation in clinical trials to assist future trials, as well as implementation of clinical and behavioral HIV prevention interventions. This study will provide an opportunity to identify and design future interventions, and could more rapidly focus resources on specific causes of postpartum morbidity and mortality for mothers and infants in developing countries.