Short Exclusive Breastfeeding to Reduce Postnatal Transmission of HIV

-描述（由申请人提供）：艾滋病毒感染母亲的母乳喂养的婴儿可以通过母乳感染艾滋病毒，这是众所周知的。在艾滋病毒占主导地位的资源匮乏环境中，母乳喂养不能简单地用配方奶粉代替，因为它往往负担不起且不安全。即使有可能更广泛地获得抗逆转录病毒药物治疗，在资源匮乏的环境中，关于不同婴儿喂养方式对艾滋病毒阳性妇女的风险和益处的问题仍然存在，其他研究没有解决这些问题。在此申请中，我们要求2年的资金来完成一项前瞻性队列研究，测试短时间（4个月）纯母乳喂养（EBF）的安全性和有效性，以最大限度地降低母婴艾滋病毒传播（MTCT）的风险，同时不增加未感染婴儿的< 2岁死亡率。在赞比亚卢萨卡的两个城市初级保健诊所，已对1435名感染艾滋病毒的孕妇及其婴儿进行了全面治疗。所有妇女都被建议纯母乳喂养到4个月。一半被随机分配到一个鼓励在4个月时突然停止BF的咨询计划中，另一半被随机分配到一个鼓励持续EBF到6个月的计划中，并引入断奶食物，并在母亲自己选择的时间内继续BF。对母婴进行为期2年的定期病史、体格检查和临床抽样调查。主要目标是比较24个月无艾滋病毒生存，并量化由于BF延长而导致的产后MTCT的程度，以及由于BF过早停止而导致的2岁以下儿童死亡的额外风险。最后几个月的随访对于量化产后晚期母婴传播和断奶相关儿童发病率和死亡率的主要研究结果至关重要。总体研究正在评估一种廉价和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，同时在资源非常匮乏的环境中保留母乳喂养对儿童健康其他方面的益处。在抗逆转录病毒药物治疗有望更广泛获得的时代，早期停止母乳喂养的相对风险和益处问题仍然至关重要。

-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.