Short Breastfeeding and Cotrimoxazole among HIV-Exposed Infants in Botswana

博茨瓦纳艾滋病毒暴露婴儿的短期母乳喂养和复方新诺明

• 批准号: 8144267
• 负责人: SHAHIN LOCKMAN
• 金额: $ 93.81万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-17 至 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8144267
• 关键词: Adult; Adverse event; Affect; Africa; Age; Age-Months; Anemia; Anti-Retroviral Agents; Birth; Botswana; Breast Feeding; Characteristics; Child; Cotrimoxazole; Counseling; Data; Developing Countries; District Hospitals; Double-Blind Method; Enrollment; Equilibrium; Event; Exclusive Breastfeeding; Feeding Methods; Goals; Government; Growth; HIV; HIV Infections; HIV-1; Hematology; Highly Active Antiretroviral Therapy; Hospitalization; Individual; Infant; Infant Mortality; Infant formula; Intervention; Intervention Studies; Life; Measures; Morbidity - disease rate; Mothers; Neutropenia; Nevirapine; Outcome; Perinatal; Placebos; Pregnant Women; Prevention; Prophylactic treatment; Qualifying; Randomized; Research Design; Resistance; Risk; Safety; Specimen; Survival Rate; Time; Toxic effect; Weaning; Woman; World Health Organization; abstracting; adverse outcome; arm; base; clinically significant; cohort; double-blind placebo controlled trial; early childhood; feeding; high risk; improved; infancy; meetings; mortality; novel; pathogen; postnatal; pregnant; prevent; prophylactic; public health relevance; randomized placebo controlled trial; randomized trial; respiratory; standard of care; transmission process; trial comparing

DESCRIPTION (provided by applicant): Abstract Priorities for improving infant HIV-free survival in the developing world include preventing late mother-to-child HIV transmission (MTCT) during breastfeeding (BF) and reducing infant mortality after weaning. We hypothesize that cotrimoxazole (CTX) prophylaxis may reduce mortality among HIV-exposed but uninfected infants, particularly early in life for formula fed (FF) infants and after weaning in BF infants. CTX may therefore allow feeding strategies that reduce the period of BF and minimize MTCT risk. The proposed study is a randomized, double-blinded, placebo-controlled trial among 3,308 mother/infant pairs. The trial will compare survival (and HIV-free survival) at 12 months among infants receiving CTX vs. placebo from 4 weeks through 12 months. Feeding strategy will be observational, and the CTX vs. placebo randomization will be balanced across feeding methods. Supported feeding options will include exclusive BF + infant nevirapine prophylaxis for up to 3 months, exclusive BF + maternal HAART (if available) for up to 6 months, or FF from birth. The primary endpoint will be survival at 12 months by CTX or placebo arm. Secondary endpoints will evaluate survival and morbidity/mortality at 18 months; safety of CTX prophylaxis; survival (and HIV-free survival) between CTX/placebo arms by feeding method; MTCT by chosen feeding method at 1, 3, 6, and 12 months; survival with early vs. later weaning; and an analysis of maternal characteristics as predictors for feeding choice and HIV-free survival. All mothers and infants will receive antenatal and peripartum standard of care prophylaxis from the Botswana Government to prevent MTCT. HAART and CTX will be available from the Botswana Government for all qualifying HIV-infected women and infants. PUBLIC HEALTH RELEVANCE: The competing risks of increased mortality from formula feeding and HIV transmission from breastfeeding remain one of the central dilemmas for early childhood survival in HIV-affected regions of the developing world. We hypothesize that in developing regions where formula feeding or early weaning are already common, the ideal balance for reducing both mother-to-child HIV transmission and infant mortality during infancy may be a short period of breastfeeding with infant nevirapine prophylaxis followed by formula feeding and infant prophylaxis with cotrimoxazole. If proven effective, these simple interventions -- used in the novel manner proposed in this randomized study -- could be combined to optimize HIV-free infant survival throughout much of the developing world.

描述（由申请人提供）： 摘要 提高发展中国家婴儿无艾滋病毒生存率的优先事项包括预防母乳喂养 (BF) 期间的晚期艾滋病毒母婴传播 (MTCT) 和降低断奶后婴儿死亡率。我们假设复方新诺明 (CTX) 预防可能会降低暴露于艾滋病毒但未感染的婴儿的死亡率，特别是配方奶喂养 (FF) 婴儿的生命早期和 BF 婴儿断奶后。因此，CTX 可能允许采用缩短 BF 期并最大限度降低 MTCT 风险的喂养策略。拟议的研究是一项在 3,308 对母婴中进行的随机、双盲、安慰剂对照试验。该试验将比较接受 CTX 治疗的婴儿与接受安慰剂治疗的婴儿在 4 周至 12 个月内的 12 个月生存率（以及无 HIV 生存率）。喂养策略将是观察性的，CTX 与安慰剂的随机化将在不同的喂养方法中保持平衡。支持的喂养选择将包括长达 3 个月的单独 BF + 婴儿奈韦拉平预防，长达 6 个月的单独 BF + 母亲 HAART（如果有），或从出生起 FF。主要终点是 CTX 组或安慰剂组 12 个月时的生存率。次要终点将评估 18 个月时的生存率和发病率/死亡率； CTX 预防的安全性；根据喂养方式，CTX/安慰剂组之间的生存率（和无 HIV 生存率）； 1、3、6、12个月时按所选喂养方式进行母婴传播；早期断奶与晚期断奶的存活率；分析母亲特征作为喂养选择和无艾滋病毒生存的预测因素。所有母亲和婴儿都将接受博茨瓦纳政府提供的产前和围产期护理标准预防措施，以预防母婴传播。博茨瓦纳政府将为所有符合条件的艾滋病毒感染妇女和婴儿提供 HAART 和 CTX。 公共卫生相关性：配方奶喂养导致的死亡率增加和母乳喂养导致的艾滋病毒传播这两个相互竞争的风险仍然是发展中国家受艾滋病毒影响地区幼儿生存的核心困境之一。我们假设，在配方奶喂养或早期断奶已经很普遍的发展中地区，减少母婴艾滋病毒传播和婴儿期婴儿死亡率的理想平衡可能是短期母乳喂养并使用奈韦拉平预防婴儿，然后使用配方奶喂养和婴儿预防用复方新诺明。如果证明有效，这些简单的干预措施（以本次随机研究中提出的新颖方式使用）可以结合起来，以优化大部分发展中国家的无艾滋病毒婴儿生存率。