Health of HIV-Infected Mothers after pMTCT, Botswana

博茨瓦纳 pMTCT 后感染艾滋病毒的母亲的健康状况

• 批准号: 6798790
• 负责人: SHAHIN LOCKMAN
• 金额: $ 25.52万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-05 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6798790
• 关键词: AIDS; AIDS therapy; Africa; HIV infections; antiviral agents; baby food; breast feeding; clinical research; clinical trials; combination chemotherapy; disease /disorder etiology; disease /disorder prevention /control; drug resistance; epidemiology; female; human morbidity; human mortality; human subject; human therapy evaluation; malnutrition; nevirapine; nutrition related tag; parents; pathologic process; patient oriented research; pharmacology; vertical transmission; women' s health

DESCRIPTION (provided by applicant): Maternal health concerns are an important but understudied aspect of programs designed to prevent mother-to-child HIV-1 transmission (MTCT) in the developing world. Two of the most important and urgent questions regarding maternal health in this context are 1) whether breastfeeding by HIV-infected women is associated with excess maternal morbidity and mortality, and 2) the response to nevirapine (NVP)-containing combination antiretroviral therapy (ART) among women who have previously taken single-dose NVP for the prevention of MTCT, given the frequent emergence of drug resistant HIV-1 after single-dose NVP. HIV-infected mothers are currently being enrolled in a NICHD-funded randomized clinical trial in Botswana that is studying strategies for MTCT prevention. Women are randomized to either perinatal prophylaxis with short course zidovudine + single-dose NVP or to zidovudine alone, and to either breastfeed while giving their infant prophylactic zidovudine or to formula-feed. Women with AIDS in this study will be offered the Government ART program first-line NVP-containing ART regimen. The primary objectives of this proposal are: 1.To examine the association between randomized infant feeding strategy (breast- versus formula feeding) and time to maternal AIDS or death, and 2. To assess the proportion of women with virologic response (plasma HIV-1 RNA < 400 copies / mL) at 52 weeks after initiating NVP-containing ART among women who previously received single-dose NVP versus placebo during labor. Secondary objectives include elucidation of the etiology of possible excess maternal morbidity and mortality associated with breastfeeding by HIV-infected mothers, including micronutrient deficiency; the emergence of genotypic resistance and virologic failure in women who previously received single-dose NVP versus placebo during labor; and the tolerability and safety of and adherence to ART among pregnant and postpartum women in Botswana. This already-existing cohort with access to ART provides a unique opportunity to answer questions that have significant public health implications with a relatively small investment of additional resources.

描述（由申请人提供）：孕产妇的健康问题是旨在防止发展中国家母亲到孩子HIV-1传播（MTCT）的计划的重要但正在研究的方面。在这种情况下，关于孕产妇健康的两个最重要和最紧迫的问题是1）艾滋病毒感染的妇女的母乳喂养是否与孕产妇的发病率和死亡率过剩有关，以及2）对奈韦拉平（NVP）的抗逆转录病毒治疗（ART）的反应是否与以前在单剂量NVP进行单剂量抗药性的情况下对MTCT的抗药性持续进行过时的女性中的妇女的反应是否相关。目前，感染HIV的母亲正在博茨瓦纳（Botswana）进行NICHD资助的随机临床试验，该试验正在研究预防MTCT的策略。妇女用短期齐多夫定 +单剂量NVP或单独使用齐多夫丁的妇女预防围产期预防，并在给予婴儿预防性Zidovudine或配方奶粉的同时进行母乳喂养。在这项研究中有艾滋病的妇女将获得政府艺术计划一线含NVP的艺术方案。该提案的主要目的是：1。检查随机婴儿喂养策略（乳房和配方奶粉喂养）与孕产妇或死亡的时间之间的关联，以及2。评估病毒学反应的女性（等离子体HIV-1 RNA <400拷贝 / ml）在52周内在启动NVP Art At Art of Sode nv的妇女中，在52周内进行了nvp，在52周内进行了启动。次要目标包括阐明病因，即可能过多的孕产妇发病率和与HIV感染的母亲有关的母乳喂养，包括微量营养素缺乏症；在分娩过程中以前接受过单剂量NVP与安慰剂的女性中基因型抗性和病毒衰竭的出现；以及博茨瓦纳孕妇和产后妇女中对艺术的耐受性和安全性。这个已经存在的与艺术品的同类人群为回答具有重大公共卫生影响的问题提供了一个独特的机会，并提供了相对较小的额外资源投资。