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

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。PACTG 219 C将讨论围产期HIV传播干预措施的影响的具体假设;初级HIV抗逆转录病毒治疗;基于免疫的治疗/疫苗试验;以及HIV感染并发症的预防和治疗对HIV或ART暴露但未感染和HIV感染的儿科患者的长期结局。长期结局包括这些干预措施的获益和不良事件，反映在生存率、临床疾病进展、生长发育、免疫功能、病毒学状态、药物不良反应和终末器官功能障碍。也可以预期，纵向数据和储存库标本收集本协议将使PACTG的研究人员能够回答其他研究问题和未来的假设特定于围产期HIV感染的病理生理学。 PACTG 219方案：儿科晚期结局方案的具体目的如下：1）描述HIV感染婴儿、儿童和青少年中与生存、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发生以及免疫学和病毒学参数相关的晚期结局。这还将包括评价受试者接受的抗逆转录病毒和免疫治疗的潜在迟发效应、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，证明由于在子宫内、围产期或婴儿早期接触病毒或治疗而引起的任何短期或长期不良临床或实验室影响。描述PACTG研究中心随访的婴儿、儿童和青少年的人口统计学和临床特征，以帮助PACTG研究者规划未来的临床试验，并确定婴儿、儿童和青少年HIV感染自然史的变化。其中包括受艾滋病毒感染的儿童的后代，这些儿童无论其艾滋病毒感染状况如何，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.