Short Exclusive Breastfeeding to Reduce Postnatal HIV

-描述(由申请人提供)：众所周知，感染艾滋病毒母亲的母乳喂养的婴儿可以通过母乳感染艾滋病毒。在艾滋病毒占主导地位的低资源环境中，母乳喂养不能简单地用配方奶粉取代，因为它往往负担不起，也不安全。即使有可能更广泛地获得抗逆转录病毒药物治疗，但在资源匮乏的情况下，对艾滋病毒阳性妇女采用不同婴儿喂养方式的风险和益处的问题仍然存在，其他研究也没有解决这些问题。通过这项申请，我们要求两年的资金来完成一项前瞻性队列研究，测试短期(4个月)纯母乳喂养(EBF)的安全性和有效性，以最大限度地减少母婴传播艾滋病毒(MTCT)的风险，而不会增加未感染婴儿的2年死亡率。在赞比亚卢萨卡的两家城市初级保健诊所，已经实现了1435名感染艾滋病毒的孕妇及其婴儿的全额应计。所有的女性都被建议纯母乳喂养到4个月。一半的人被随机分配到一个咨询计划中，该计划鼓励在4个月时突然停止BF，另一半的人参加的计划是鼓励通过引入断奶食物来持续EBF到6个月，并在母亲自己选择的时间内继续BF。对母婴配对进行为期2年的跟踪调查，定期进行病史、体检和临床抽样。主要目标是比较24个月的无艾滋病毒生存，并量化因胎龄延长而导致的出生后MTCT的大小，以及因提前停止胎龄而导致的2岁以下死亡的额外风险。最后几个月的随访对于量化出生后晚期母婴传播的主要研究结果以及与断奶相关的儿童发病率和死亡率至关重要。整个研究正在评估一种廉价且可能可持续的公共卫生干预措施，以减少通过母乳喂养传播艾滋病毒，同时在非常低的资源环境下保留母乳喂养对儿童健康的其他方面的好处。在抗逆转录病毒药物治疗即将得到更广泛应用的时代，提前停止母乳喂养的相对风险和好处的问题仍然至关重要。

-DESCRIPTION (provided by applicant): It is well established that breast fed infants of HIV-infected mothers can acquire HIV infection through breast milk. In low resource settings, where HIV predominates, breastfeeding (BF) cannot simply be replaced by formula since it is often unaffordable and unsafe. Even with the potential for more widespread access to antiretroviral drug treatment, questions about the risks and benefits of different infant feeding modalities for HIV-positive women in low resource settings remain and are not being addressed by other studies. With this application we request 2 years of funding to complete a prospective cohort study testing the safety and efficacy of short duration (4 months) exclusive breast feeding (EBF) to minimize risks of mother to child HIV transmission (MTCT) without increasing < 2-year mortality among uninfected infants. Full accrual of 1435 HIV-infected pregnant women and their infants has been achieved at two urban primary health care clinics in Lusaka, Zambia. All women are counseled to exclusively breastfeed to 4 mo. Half are randomized to a counseling program encouraging abrupt cessation of BF at 4 mo, and half to a program that encourages continued EBF through 6 mo with the introduction of weaning foods and continued BF for a duration of the mother's own choice. Mother infant pairs are followed for 2 years with regular medical histories, physical exams and clinical sampling. The primary objective is to compare 24-mo HIV-free survival and to quantify the magnitude of postnatal MTCT due to prolonged BF, and the excess risks of under-2 year mortality due to early cessation of BF. The final months of followup are critical to quantify the primary study outcomes of late postnatal MTCT and weaning associated child morbidity and mortality. The overall study is evaluating an inexpensive and potentially sustainable public health intervention to reduce HIV transmission through breast feeding while preserving benefits of breast feeding for other aspects of child health in a very low resource setting. The question of the relative risks and benefits of early cessation of breastfeeding remains crucially relevant in an era where antiretroviral drug treatment is poised to become more widely available.