Pediatric HIV/AIDS Cohort Study (PHACS) Coordinating Center (CC) (U01)

 描述（由申请人提供）：儿科HIV AIDS队列研究（PHACS）解决了两个重要的研究问题：（1）在妊娠期间暴露于HIV-1感染母亲服用的抗逆转录病毒（ARV）药物的胎儿是否存在风险;（2）随着年龄的增长，围产期HIV感染的儿童的临床过程是什么。这些问题正在通过三个独立的方案在美国包括波多黎各在内的21个PHACS诊所进行解决。 SMARTT研究的具体目的是确定暴露于艾滋病毒但未感染的婴儿中ARV暴露的短期和长期安全性。为了做到这一点，对受感染母亲所生的未感染艾滋病毒的儿童进行前瞻性评估，以确定生长、发育、语言、听力、心脏和神经功能以及其他器官系统的异常。对有异常的儿童进行进一步评估，以确定这些异常是否与接触特定的抗逆转录病毒药物有关。其他原因的异常也进行了调查。这些信息将有助于决定哪些抗逆转录病毒药物对妇女在怀孕期间服用最安全-既用于自己的治疗，也用于防止孩子感染。 AMP研究的具体目的是，在围产期感染艾滋病毒的青春期前和青少年中：（1）确定艾滋病毒感染和抗逆转录病毒药物对其生长和发育的影响;性成熟;心血管疾病危险因素的发展;认知，学术，职业，性和社会功能;心理健康;以及冒险行为，包括物质使用;（2）确定艾滋病毒和抗逆转录病毒治疗的感染性和非感染性并发症，包括终末器官疾病（神经、肾、肺、骨）和营养代谢异常;（3）研究改变艾滋病毒感染过程及其对治疗反应的遗传、病毒学（包括抗逆转录病毒耐药性）和免疫因素。第二项研究，AMP Up，允许AMP参与者在年满18岁后被跟踪到成年，利用结合亲自访问和在线数据收集的不太密集的研究设计。由于患有围产期艾滋病毒的青年现在已经成年，AMP Up的一个重要目标是了解他们向成年的过渡和成人医疗保健。由于儿童艾滋病毒现在是一种慢性疾病，了解艾滋病毒感染及其治疗的长期结果是必要的，为他们提供最佳的长期护理。 在所有研究中，根据标准方案对参与者进行前瞻性评估。两者均采用触发评价策略，特定的异常结果导致更深入的评价，以进一步表征异常。收集储存库标本，以便进行额外的生化和基因检测。

 DESCRIPTION (provided by applicant): The Pediatric HIV AIDS Cohort Study (PHACS) addresses two important research questions: (1) Is there a risk to fetuses who are exposed to antiretroviral (ARV) drugs taken by their HIV-1-infected mother during pregnancy; and (2) What is the clinical course of children with perinatal HIV infection as they age through adolescence towards adulthood. These questions are being addressed through three separate protocols being conducted at 21 PHACS clinic sites in the US including Puerto Rico. The specific aim of the SMARTT Study is to define the short and long-term safety of ARV exposure among HIV-exposed but uninfected infants. To accomplish this, HIV-uninfected children born to infected mothers are evaluated prospectively in order to identify abnormalities of growth, development, language, hearing, cardiac and neurologic function, and other organ systems. Children with abnormalities are further evaluated to determine if these abnormalities are associated with exposure to specific ARVs. Other causes of the abnormalities are also investigated. This information will help in deciding which ARVs are safest for a woman to take during pregnancy - both for her own treatment and to prevent infection of her child. The specific aims of the AMP study are, among pre-adolescents and adolescents with perinatal HIV infection: (1) To define the impact of HIV infection and ARVs on their growth and development; sexual maturation; development of risk factors for cardiovascular disease; cognitive, academic, vocational, sexual, and social functioning; mental health; and risk taking behavior including substance use; (2) To identify infectious and non-infectious complication of HIV and ARV therapy, including end organ disease (neurologic, renal, pulmonary, bone) and nutritional and metabolic abnormalities; and (3) to study genetic, virologic (including antiretroviral resistance), and immunologic factors whic alter the course of HIV infection and its response to treatment. A second study, AMP Up, allows the AMP participant to be followed into adulthood once they turn 18 years of age, utilizing a less intensive study design that combines both in-person visits and on-line data collection. Since youth with perinatal HIV are now reaching adulthood, an important goal of AMP Up is to learn about their transitioning to adulthood and adult medical care. Since pediatric HIV is now a chronic disease, an understanding of the long-term outcomes of HIV infection and its treatment is necessary to provide them with optimal long-term care. In all studies, participants are evaluated prospectively according to a standard protocol. Both utilize a strategy of triggered evaluations, with specific abnormal findings leading to more intensive evaluations to further characterize the abnormality. Repository specimens are collected to allow for additional biochemical and genetic testing.