Short Breastfeeding and Cotrimoxazole among HIV-Exposed Infants in Botswana

描述(申请人提供)：摘要提高发展中国家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)和降低婴儿断奶后的死亡率。我们假设，复方新诺明(CTX)预防可以降低HIV感染但未感染的婴儿的死亡率，特别是在配方奶(FF)婴儿的生命早期和BF婴儿断奶后。因此，CTX可能允许采取喂养策略，以缩短BF的时间并将母婴传播的风险降至最低。这项拟议的研究是一项随机、双盲、安慰剂对照试验，涉及3308对母婴。这项试验将比较接受CTX治疗的婴儿和服用安慰剂的婴儿在4周到12个月期间的12个月存活率(和无艾滋病毒存活率)。喂养策略将是观察性的，CTX与安慰剂的随机对照将在喂养方法上进行平衡。支持的喂养选项将包括最多3个月的独家BF+婴儿奈韦拉平预防，最多6个月的独家BF+产妇HAART(如果有)，或从出生起的FF。主要终点将是服用CTX或安慰剂的患者在12个月内存活。次级终点将评估18个月后的生存率和发病率/死亡率；环磷酰胺预防的安全性；通过喂养方法的环磷酰胺/安慰剂组之间的存活(和无艾滋病毒生存)；在1、3、6和12个月时按选择的喂养方法进行的母婴传播；早期断奶与较晚断奶的生存；以及作为喂养选择和无艾滋病毒生存预测因素的母亲特征分析。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预防标准护理，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。

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.