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

儿科艾滋病毒/艾滋病队列研究 (PHACS) 协调中心 (CC) (U01)

• 批准号: 9757795
• 负责人: RUSSELL B. VAN DYKE
• 金额: $ 50.54万
• 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 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9757795
• 关键词: 12 year old; 15 year old; 17 year old; 18 year old; Acquired Immunodeficiency Syndrome; Address; Adolescence; Adolescent; Adolescent and Young Adult; Adult; Adverse event; Age; Alcohol consumption; Alcohol or Other Drugs use; Anti-Retroviral Agents; Antiretroviral resistance; Behavior; Biochemical Genetics; Birth; Body Composition; Bone Development; Cardiovascular Diseases; Caregivers; Caring; Child; Child Care; Child Mental Health; Chronic Disease; Clinic; Clinical; Cognitive; Cohort Studies; Complication; Data; Data Collection; Development; Disease; Drug toxicity; Drug usage; Enrollment; Epigenetic Process; Evaluation; Exposure to; Fetus; Genetic; Genetic screening method; Genetic study; Goals; Growth; Growth and Development function; HIV; HIV Infections; HIV antiretroviral; HIV therapy; HIV-1; HIV-exposed uninfected infant; Hearing; Hour; Immunologic Factors; Infant; Infection prevention; Kidney; Language; Leadership; Learning; Long-Term Care; Longterm Follow-up; Lung; Medical; Mental Health; Metabolic; Mitochondria; Monitor; Mothers; Nervous System Physiology; Neurologic; Newborn Infant; Nutritional; Oral health; Organ; Outcome; Participant; Pediatric HIV/AIDS Cohort Study; Perinatal; Perinatal transmission; Persons; Pharmaceutical Preparations; Pharmacotherapy; Physiologic calcification; Pregnancy; Pregnant Women; Prevention; Productivity; Protocols documentation; Puerto Rico; Recommendation; Research; Research Design; Risk; Risk Factors; Risk-Taking; Safety; Sex Functioning; Sexual Maturation; Site; Social Functioning; Specimen; Structure; Tobacco use; Toxic effect; Universities; Visit; Woman; Youth; antiretroviral therapy; body system; bone; cardiovascular disorder risk; cardiovascular risk factor; cohort; comparison group; experience; glucose metabolism; heart function; in utero; innovation; lipid metabolism; medication compliance; mitochondrial dysfunction; neonatal exposure; neurodevelopment; operation; pediatric human immunodeficiency virus; perinatal HIV; physical conditioning; preadolescence; prospective; public health relevance; recreational drug use; recruit; repository; reproductive; side effect; transmission process; treatment response; virology; young adult

 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.

 描述（由申请人提供）：儿科 HIV 艾滋病队列研究 (PHACS) 解决了两个重要的研究问题：(1) 胎儿在感染 HIV-1 的母亲服用抗逆转录病毒 (ARV) 药物后是否存在风险？ (2) 围产期艾滋病毒感染儿童从青春期到成年的临床过程是什么？这些问题正在通过 21 日进行的三个单独方案得到解决。包括波多黎各在内的美国 PHACS 诊所站点 SMARTT 研究的具体目的是确定感染艾滋病毒但未感染的婴儿接触抗逆转录病毒药物的短期和长期安全性。对患有异常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，以确定这些异常是否与接触特定抗逆转录病毒药物有关。还对异常情况进行了调查，这将有助于确定女性在怀孕期间服用哪种抗逆转录病毒药物最安全，既可以用于自身治疗，也可以预防孩子感染。围产期艾滋病毒感染的青少年：(1) 明确艾滋病毒感染和抗逆转录病毒药物对其生长发育的影响；心血管疾病的危险因素；健康;风险行为，包括物质使用；(2) 识别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）以及营养和代谢异常；遗传、病毒学（包括抗逆转录病毒耐药性）和免疫学因素会改变 HIV 感染的过程及其对治疗的反应，第二位参与者 AMP Up 允许在 18 岁后跟踪 AMP 至成年，采用结合面对面访问和在线数据收集的强度较低的研究设计，由于感染围产期艾滋病毒的青少年现已成年，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护理。儿童艾滋病毒现在是一种慢性疾病，了解艾滋病毒感染的长期结果及其治疗对于为他们提供最佳的长期护理是必要的。在所有研究中，参与者都根据所使用的标准方案进行前瞻性评估。触发评估的策略，特定的异常发现导致进行更深入的评估，以进一步表征异常情况。收集样本以进行额外的生化和基因检测。

项目成果

Marijuana, Opioid, and Alcohol Use Among Pregnant and Postpartum Individuals Living With HIV in the US.

美国艾滋病毒感染者怀孕和产后个体的大麻、阿片类药物和酒精使用情况。

• 发表时间: 2021-12-01
• 影响因子: 13.8
• 作者: Yee, Lynn M;Kacanek, Deborah;Brightwell, Chase;Haddad, Lisa B;Jao, Jennifer;Powis, Kathleen M;Yao, Tzy;Barr, Emily;Broadwell, Carly;Siminski, Suzanne;Seage 3rd, George R;Chadwick, Ellen G;Pediatric HIV/AIDS Cohort Study
• 通讯作者: Pediatric HIV/AIDS Cohort Study