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.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 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晚期结局。在感染艾滋病毒的婴儿和儿童中，“晚期后果”一词一般用于描述可能与艾滋病毒疾病进展、治疗效果(包括预防和治疗机会性疾病)和/或艾滋病毒疾病和治疗的相互作用有关的长期后果。这是基于这样一种基本原理，即区分药物效应和疾病效应并不总是可能的。该方案的主要目的是纵向跟踪参与PACTG临床试验的婴儿、儿童和青少年，以监测治疗的晚期后果，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、程序、生长和发育、营养、心理社会参数、神经发育评估、免疫学和病毒学状况以及疾病进展的自然历史数据。这一长期后续行动议定书的第一个版本(1.0版)于1993年实施。已对其进行了三次修订(目前为4.0版)，以改善对目前存活到较大年龄的婴儿的长期跟踪，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地点跟踪的儿童HIV感染患者的人口。预计入学的儿童人数(4150人)使主要和次要目标以及PACTG 219C的13个假设得以强有力地解决。