Coordinating Center for the Pediatric HIV/AIDS Cohort Study II

儿科艾滋病毒/艾滋病队列研究 II 协调中心

• 批准号: 8305553
• 负责人: RUSSELL B. VAN DYKE
• 金额: $ 97.75万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8305553
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Adolescence; Adolescent; Adult; Alcohol or Other Drugs use; Antiretroviral resistance; Behavior; Biochemical Genetics; Cardiac; Cardiotoxicity; Cardiovascular Diseases; Caregivers; Centers for Disease Control and Prevention (U.S.); Child; Child Care; Childhood; Chronic; Clinical; Cognitive; Cohort Studies; Collaborations; Complication; Data; Data Base Management; Development; Disease; Doctor of Philosophy; Endocrinology; Epidemiology; Epigenetic Process; Evaluation; Event; Exposure to; Genetic; Genetic screening method; Goals; Growth; Growth and Development function; Gynecology; HIV; HIV Infections; HIV-1; IMPAACT; Immunologic Factors; Individual; Infant; Infection; Kidney; Leadership; Lung; Mental Health; Metabolic; Mitochondrial Diseases; Mothers; Neurologic; Nutritional; Organ; Outcome; Perinatal; Pharmaceutical Preparations; Pharmacoepidemiology; Pregnancy; Preventive; Principal Investigator; Protocols documentation; Puberty; Puerto Rico; Recruitment Activity; Research; Research Infrastructure; Risk Assessment; Risk Factors; Risk-Taking; Safety; Sexual Maturation; Site; Social Functioning; Specimen; Toxic effect; Universities; Vertical Disease Transmission; Woman; antiretroviral therapy; bone; clinical research site; cohort; emerging adult; experience; fetal; in utero; member; mitochondrial dysfunction; nervous system disorder; neurodevelopment; neuroimaging; neuropsychological; nutrition; operation; pediatric human immunodeficiency virus; pediatric human immunodeficiency virus infection; prevent; public health relevance; repository; response; transmission process; working group

DESCRIPTION (provided by applicant): The Pediatric HIV AIDS Cohort Study addresses two critical research questions: (1) the consequences of fetal and infant exposure to antiretroviral therapy (ART) when used to prevent mother-to-child transmission of HIV-1, and (2) the clinical course of perinatal HIV infection among children as they proceed through adolescence towards adulthood. These questions are being addressed through two separate protocols being conducted at multiple sites in the US and Puerto Rico. The specific aim of the SMARTT Study is, among HIV-exposed infants, to define the short and long-term safety of ART exposure. To accomplish this, HIV-uninfected children born to infected mothers are evaluated prospectively for growth, neurodevelopment, cardiac and other end-organ function. Children with abnormalities will be further evaluated to determine if they result from ART toxicity, with particular emphasis on mitochondrial dysfunction. The specific aims of AMP are, among a cohort of pre-adolescents and adolescents with perinatal HIV (1) to define the impact of HIV infection and ART on: growth and development; sexual maturation; pubertal development; 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 disease and ART therapy, including end organ disease (neurologic, renal, pulmonary, bone) and nutritional and metabolic abnormalities. (3) to study genetic, epigenetic, virologic (including antiretroviral resistance), and immunologic factors which impact the course of HIV infection, its complications and response to treatment. In both protocols, subjects and their primary caregivers are prospectively evaluated according to a standardized protocol. Both utilize a strategy of triggered evaluations, with specific abnormal findings leading to additional evaluations to characterize the abnormality. Repository specimens are collected for further biochemical and genetic testing. PUBLIC HEALTH RELEVANCE: Defining the safety of preventive ART during pregnancy - including the safety of individual drugs - is necessary to define the safest strategy to prevent mother-to-transmission of HIV. Perinatal HIV has become a chronic condition, and an understanding of the long-term outcomes of the infection and its treatment is necessary to provide care for these children.

描述（由申请人提供）：儿科 HIV 艾滋病队列研究解决了两个关键的研究问题：(1) 当用于预防 HIV-1 母婴传播时，胎儿和婴儿接受抗逆转录病毒治疗 (ART) 的后果， (2) 儿童从青春期到成年期间的围产期 HIV 感染的临床过程。这些问题正在通过在美国和波多黎各多个地点进行的两个单独的协议得到解决。 SMARTT 研究的具体目的是在暴露于 HIV 的婴儿中确定 ART 暴露的短期和长期安全性。为了实现这一目标，对感染艾滋病毒的母亲所生的未感染艾滋病毒的儿童进行前瞻性评估，了解其生长、神经发育、心脏和其他终末器官功能。患有异常的儿童将接受进一步评估，以确定其是否由 ART 毒性引起，特别强调线粒体功能障碍。 AMP 的具体目标是，在一群患有围产期 HIV 的青春期前和青少年中 (1) 确定 HIV 感染和 ART 对以下方面的影响： 生长和发育；性成熟；青春期发育；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）识别HIV疾病和ART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）以及营养和代谢异常。 (3) 研究影响HIV感染过程、并发症和治疗反应的遗传、表观遗传、病毒学（包括抗逆转录病毒耐药性）和免疫学因素。在这两种方案中，受试者及其主要照顾者都根据标准化方案进行前瞻性评估。两者都采用触发评估策略，特定的异常发现导致额外的评估来表征异常。收集储存样本以进行进一步的生化和基因检测。 公共卫生相关性：确定怀孕期间预防性抗逆转录病毒治疗的安全性（包括个别药物的安全性）对于确定预防艾滋病毒母婴传播的最安全策略是必要的。围产期艾滋病毒已成为一种慢性疾病，了解感染的长期后果及其治疗对于为这些儿童提供护理是必要的。