ACTG 219: PEDIATRIC LATE OUTCOMES-INFANTS AND CHILDREN WITH HIV INFECTION

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。PACTG 219C将阐述与围产期艾滋病毒传播干预措施有关的具体假设；艾滋病毒抗逆转录病毒的初级治疗；基于免疫的治疗/疫苗试验；以及预防和治疗艾滋病毒感染的并发症对艾滋病毒或ART暴露但未感染的儿科患者和感染艾滋病毒的儿童患者的长期结果的影响。长期结果包括这些干预措施的益处和不良事件，如生存、临床疾病进展、生长和发育、免疫功能、病毒学状况、药物不良反应和终末器官功能障碍。还预计，在该方案中收集的纵向数据和储存库样本将使PACTG的研究人员能够回答其他研究问题和未来特定于围产期艾滋病毒感染的病理生理学的假设。PACTG 219：儿科晚期结局方案的具体目标如下：1)描述随着时间的推移，与HIV感染婴儿、儿童和青少年的生存、生长、神经和神经心理功能、生活质量、器官系统毒性、代谢紊乱、机会性感染和恶性肿瘤的发展以及免疫学和病毒学参数有关的晚期结局。这还将包括评估受试者接受抗逆转录病毒和免疫治疗的潜在后遗症、青春期影响和并发症；2)确定符合以下任何标准的妇女所生的未感染婴儿：a)被诊断为艾滋病毒感染者；b)在怀孕期间接受抗逆转录病毒治疗；c)在怀孕期间接受免疫治疗/艾滋病毒疫苗接种；3)证明在子宫、围产期或早期婴儿期接触病毒或治疗有任何短期或长期的不良临床或实验室影响；以及3)描述在PACTG地点跟踪的婴儿、儿童和青少年的人口学和临床特征，以帮助PACTG调查人员计划未来的临床试验，并确定婴儿、儿童和青少年艾滋病毒感染自然史的变化。其中包括感染艾滋病毒的儿童的后代，无论他们的艾滋病毒感染状况如何，他们都可能遭受长期后果。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. PACTG 219C will address specific hypotheses in relation to the impact of perinatal HIV transmission interventions; primary HIV antiretroviral therapies; immune-based therapy/vaccines trials; and prophylaxis and treatment of the complications of HIV infection on long-term outcomes in HIV or ART exposed but uninfected, and HIV-infected pediatric patients. The long-term outcomes include benefits as well as adverse events from these interventions as reflected in survival, clinical disease progression, growth and development, immunologic function, virologic status, adverse drug reactions, and end-organ dysfunction. It is also anticipated that the longitudinal data and the repository specimens collected in this protocol will enable investigators in the PACTG to answer other research questions and future hypotheses specific to the pathophysiology of perinatal HIV infection. The specific aims for protocol PACTG 219: pediatric late outcomes protocol is as follows: 1) To describe late outcomes over time in relation to survival, growth, neurologic and neuropsychologic function, quality of life, organ system toxicity, metabolic disorders, development of opportunistic infections and malignancies and immunologic and virologic parameters in HIV-infected infants, children, and adolescents. This will also include evaluation of potential late effects, impact of puberty and complications of antiretroviral and immune therapy received by the subjects; 2) To determine if uninfected infants born to women who meet any of the following criteria: a) Diagnosed as HIV-infected b) Received antiretroviral therapy during pregnancy c) Received immune therapy/HIV-vaccines during pregnancy, demonstrate any short or long term adverse clinical or laboratory effects due to viral or treatment exposure in utero, the perinatal period, or early infancy.; and 3) To describe the demographic and clinical characteristics of infants, children, and adolescents followed at PACTG sites in order to assist PACTG investigators in planning future clinical trials and to identify changes in the natural history of HIV infection in infants, children, and adolescents. Included are the offspring of HIV infected children who may suffer long-term consequences regardless of their HIV-infection status.