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: 9073896
• 负责人: SHAHIN LOCKMAN
• 金额: $ 34.81万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-17 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9073896
• 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; HIV-exposed uninfected infant; 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; 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.

描述（由申请人提供）：改善发展中国家婴儿艾滋病毒生存的抽象优先级包括在母乳喂养（BF）（BF）（BF）和断奶后降低婴儿死亡率期间预防母亲到孩子的艾滋病毒传播（MTCT）。我们假设可替妥莫恶唑（CTX）预防可能会降低艾滋病毒暴露但未感染的婴儿的死亡率，尤其是在喂养（FF）婴儿（FF）婴儿的早期以及在BF婴儿中断奶后的生命早期。因此，CTX可以允许降低BF周期并最大程度降低MTCT风险的喂养策略。拟议的研究是一项随机，双盲，安慰剂对照试验，对3,308对母/婴儿对。该试验将比较接受CTX与安慰剂相对于4周到12个月的安慰剂的婴儿的生存期（和无艾滋病毒生存期）。喂养策略将是观察性的，CTX与安慰剂随机化将在喂养方法中平衡。受支持的喂养方案将包括最多3个月的BF +婴儿奈韦拉平的独家预防，BF +母体Haart（如果可用）最多6个月，或从出生起的FF。主要终点将通过CTX或安慰剂组在12个月的生存。次要终点将评估18个月的生存和发病率/死亡率； CTX预防的安全；通过喂养方法，CTX/安慰剂臂之间的生存（和无艾滋病毒生存）； MTCT通过1、3、6和12个月的选定喂养方法；生存与早期与后来的断奶；以及对母体特征作为喂养选择和无艾滋病毒生存的预测因素的分析。所有母亲和婴儿将从博茨瓦纳政府获得预防的产前和周围的护理标准，以防止MTCT。 HAART和CTX将为所有有资格的HIV感染妇女和婴儿提供可从博茨瓦纳政府提供。