ZDV USE TO PREVENT MATERNAL/INFANT HIV TRANSMISSION

描述（由申请人提供）：尽管在资源有限的环境中，减少子宫内和分娩期间艾滋病毒传播的有效和可行的手段现已成为可能，但通过母乳喂养预防产后艾滋病毒传播仍然是一项重大挑战。目前正在与乌干达坎帕拉和印度浦那正在进行的研究合作进行的这项研究将评估奈韦拉平6周预防性治疗方案在预防母乳喂养婴儿中艾滋病毒传播方面的效果。主要终点是6个月大的婴儿HIV感染状况。迄今为止，559名艾滋病毒血清阳性妇女已被纳入这项随机双盲研究，6个月大时婴儿随访率为93%。埃塞俄比亚将招募770名血清检测呈阳性的母乳喂养妇女。登记将在大约6-8个月内完成，对妇女及其婴儿的最终随访将在12个月后结束。在许多资源贫乏的环境中，继续支持感染艾滋病毒妇女的母乳喂养，因为与替代喂养有关的发病率和死亡率风险过高。然而，至少有一项研究表明，艾滋病毒感染妇女所生婴儿的替代喂养可能不一定与这种风险增加有关。在埃塞俄比亚进行的这项研究正在评估与婴儿喂养做法有关的风险，同时还招募并跟踪了另外两个队列：非母乳喂养感染艾滋病毒的妇女及其婴儿和艾滋病毒阴性的妇女及其婴儿。来自随机队列研究的数据将有助于确定母乳喂养早期婴儿预防是否可以显著减少产后传播。如上所述，迫切需要可行有效的干预策略来防止通过母乳喂养传播艾滋病毒。按喂养方式分列的发病率和死亡率的数据将为今后的政策决定提供信息，以处理感染艾滋病毒的妇女某种喂养方式的风险和益处。

DESCRIPTION (provided by applicant): Although effective and feasible means of reducing in-utero and intra-partum HIV transmission are now becoming available in resource-limited settings, prevention of post-partum transmission through breastfeeding remains a critical challenge. This study, now being conducted in collaboration with studies underway in Kampala, Uganda and Pune, India will evaluate the efficacy of a 6 week prophylactic regimen of nevirapine in the prevention of HIV transmission among breastfed infants. The primary endpoint is infant HIV infection status at 6 months of age. To date, 559 HIV seropositive women have been enrolled in this randomized, double-masked study with a 93% infant follow-up rate at 6 months of age. A total of 770 seropositive, breastfeeding women will be enrolled in Ethiopia. Enrollment will be completed in approximately 6-8 months with final follow-up of the women and their infants ending 12 months later. Breastfeeding among HIV-infected women continues to be supported in many resource poor settings because of the excess risk of morbidity and mortality associated with alternative feeding. However, at least one study has suggested that alternative feeding of infants born to HIV-infected women may not necessarily be associated with such increased risks. The study in Ethiopia is evaluating the risks associated with infant feeding practices by also enrolling and following two additional cohorts: non-breastfeeding HIV-infected woman and their infants and HIV negative women and their infants. Data from the randomized cohort study will assist in determining whether infant prophylaxis early in breastfeeding can significantly reduce post-partum transmission. As indicated above, feasible effective intervention strategies to prevent HIV transmission through breastfeeding are urgently needed. The data regarding morbidity and mortality rates by feeding modality will inform future policy decisions addressing the risks and benefits of a given feeding practice for HIV-infected women.