Short Breastfeeding and Cotrimoxazole among HIV-Exposed Infants in Botswana

摘要在发展中国家，提高婴儿无艾滋病毒生存率的优先事项包括预防母乳喂养期间母婴艾滋病毒传播（MTCT）和降低断奶后婴儿死亡率。我们假设复方新诺明（CTX）预防可能降低艾滋病毒暴露但未感染婴儿的死亡率，特别是在生命早期配方喂养（FF）婴儿和断奶后的BF婴儿。因此，CTX可能允许缩短BF周期和最小化MTCT风险的喂养策略。该研究是一项随机、双盲、安慰剂对照试验，涉及3308对母婴。该试验将比较接受CTX和安慰剂治疗的婴儿在12个月时的4周到12个月生存率（和无艾滋病毒生存率）。喂养策略将是观察性的，CTX和安慰剂的随机化将在喂养方法之间进行平衡。支持的喂养选择将包括最多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（如果有的话），或从出生开始FF。主要终点将是CTX组或安慰剂组的12个月生存率。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；通过喂养法CTX/安慰剂组之间的生存（和无hiv生存）；分别于1、3、6、12月龄采用选择喂养方式进行MTCT；早期与较晚断奶的生存率；以及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获得博茨瓦纳政府提供的产前和围产期标准护理预防，以防止母婴传播。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治疗。

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.