ACTG #219C: PEDIATRIC LATE OUTCOMES PROTOCOL

ACTG

• 批准号: 7605048
• 负责人: Elizabeth Jane McFarland
• 金额: $ 18.47万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605048
• 关键词: AIDS clinical trial group; Address; Adolescent; Age; Anti-Retroviral Agents; Child; Childhood; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Data; Diagnosis; Disease; Disease Progression; Enrollment; Evaluation; Funding; Grant; Growth and Development function; HIV; Immunologics; Infant; Institution; Intervention Trial; Monitor; Natural History; Numbers; Outcome; Patients; Perinatal; Pharmaceutical Preparations; Population; Procedures; Prophylactic treatment; Protocols documentation; Quality of life; Research; Research Personnel; Resources; Signs and Symptoms; Site; Source; Supportive care; United States National Institutes of Health; base; demographics; follow-up; improved; in utero; infancy; nutrition; perinatal intervention; social; treatment effect

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 中心，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早期接受艾滋病毒抗逆转录病毒治疗的儿童的后期结果。 在感染艾滋病毒的婴儿和儿童中，术语“晚期结果”通常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/或相互作用相关的长期后果。艾滋病毒疾病和治疗。 这是基于区分药物作用和疾病作用并不总是可能的基本原理。 该方案的主要目的是纵向跟踪参加 PACTG 临床试验的婴儿、儿童和青少年，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。 该试验收集诊断、体征和症状、药物、手术、生长和发育、营养、心理社会参数、神经发育评估、免疫和病毒学状态以及疾病进展的自然历史数据。 该长期随访方案的第一版（1.0 版）于 1993 年实施。已进行了 3 次修订（目前为 4.0 版），以改善目前存活至较大年龄的婴儿的长期随访，因为并认识到围产期干预试验的积极影响。 当前版本包括围产期、主要治疗、并发症和支持护理/生活质量问题下的假设。 所有版本的 PACTG 219/219C 患者的人口统计数据反映了在美国各地 PACTG 站点追踪的儿童 HIV 感染患者的人数。 预计入学儿童人数 (4150) 可以有效解决主要和次要目标以及 PACTG 219C 的 13 个假设。