ACTG #219C: PEDIATRIC LATE OUTCOMES PROTOCOL

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这是一项观察性试验，旨在调查感染艾滋病毒的儿童或在子宫内和婴儿期早期接受艾滋病毒抗逆转录病毒治疗的儿童的晚期结局。在感染艾滋病毒的婴儿和儿童中，“晚期结果”一词一般用于描述可能与艾滋病毒疾病进展、治疗效果（包括机会性疾病的预防和治疗）和/或艾滋病毒疾病与治疗的相互作用有关的长期后果。这是基于这样一个基本原理，即区分药物效应和疾病效应可能并不总是可能的。该方案的主要目的是对参加PACTG临床试验的婴儿、儿童和青少年进行纵向随访，以监测治疗的后期后果，包括对长期生存和生活质量的影响。该试验收集了诊断、体征和症状、药物、手术、生长发育、营养、社会心理参数、神经发育评估、免疫和病毒学状态以及疾病进展的自然史数据。这个长期后续协议的第一个版本（1.0版本）于1993年实现。它已经修订了三次（目前是4.0版），以改善对现在存活到更大年龄的婴儿的长期随访，并认识到围产期干预试验的积极影响。目前的版本包括围产期、初级治疗、并发症和支持性护理/生活质量问题的假设。所有版本PACTG 219/219C患者的人口统计数据反映了在美国PACTG站点跟踪的儿科HIV感染患者的人口。预期的入组儿童数量（4150）使主要和次要目标以及PACTG 219C的13个假设得到了有力的解决。

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. This is an observational trial to investigate the late outcomes of children infected with HIV or children exposed to HIV antiretroviral treatment in utero and in early infancy. Among HIV-infected infants and children, the term "late outcomes" will be used generically to describe long-term consequences that may be related to HIV disease progression, treatment effects (including prophylaxis and treatment of opportunistic diseases), and/or interactions of HIV disease and therapy. This is based on the rationale that distinguishing drug effects from disease effects may not always be possible. The major aim of the protocol was to longitudinally follow infants, children, and adolescents who had participated in PACTG clinical trials in order to monitor late consequences of therapy including effects on long-term survival and quality of life. The trial collects natural history data for diagnoses, signs and symptoms, medications, procedures, growth and development, nutrition, psycho-social parameters, neurodevelopmental evaluations, immunologic and virologic status, and disease progression. The first version of this long-term follow-up protocol (Version 1.0) was implemented in 1993. It has been revised on three occasion (currently Version 4.0) to improve long-term follow-up of infants now surviving to older ages, as well as to recognize the positive impact of perinatal intervention trials. The current version includes hypotheses under Perinatal, Primary Therapy, Complications and Supportive Care/Quality of Life issues. The demographics of all versions of PACTG 219/219C patients reflect the population of pediatric HIV infected patients followed at PACTG sites across the USA. The anticipated number of children enrolled (4150) allows the primary and secondary objectives, as well as the 13 hypotheses of PACTG 219C to be addressed with high power.