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）：摘要在发展中国家提高婴儿无艾滋病毒存活率的优先事项包括预防母乳喂养（BF）期间的晚期母婴艾滋病毒传播（MTCT）和降低断奶后的婴儿死亡率。我们假设复方新诺明（CTX）预防可能会降低HIV暴露但未感染的婴儿的死亡率，特别是配方奶粉喂养（FF）婴儿的生命早期和BF婴儿断奶后。因此，CTX可以允许喂养策略，减少BF的时间和最大限度地减少MTCT风险。这项研究是一项随机、双盲、安慰剂对照的试验，共有3,308对母婴参与。该试验将比较从4周到12个月接受CTX与安慰剂的婴儿在12个月时的生存率（和无艾滋病毒生存率）。喂养策略将是观察性的，CTX与安慰剂的随机化将在不同喂养方法中平衡。支持的喂养选择将包括从出生起最长3个月的专属BF +婴儿奈韦拉平预防，最长6个月的专属BF +母体HAART（如可用），或FF。主要终点将是CTX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; CTX/安慰剂组之间按喂养方式分类的生存率（和无HIV生存率）;按所选喂养方式分类的1、3、6和12个月时的MTCT;早期与晚期断奶的生存率;以及对母亲特征作为喂养选择和无艾滋病毒生存预测因素的分析。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标准护理预防，以预防母婴传播。博茨瓦纳政府将向所有符合条件的感染艾滋病毒的妇女和婴儿提供HAART和CTX。