ACTG 219C: PEDIATRIC LATE OUTCOME PROTOCOL, VERSION 30 HIV/AIDS

ACTG 219C：儿科晚期结果方案，版本 30 HIV/AIDS

• 批准号: 7608334
• 负责人: Hans M Spiegel
• 金额: $ 1.42万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7608334
• 关键词: AIDS clinical trial group; AIDS/HIV problem; Adolescent; Anti-Retroviral Agents; Child; Clinical; Computer Retrieval of Information on Scientific Projects Database; Development; Enrollment; Evaluation; Exposure to; Funding; Grant; Growth; Immunologics; Immunotherapy; Infant; Infection; Institution; Laboratories; Late Effects; Longitudinal Studies; Malignant Neoplasms; Metabolic Diseases; Neurologic; Neuropsychology; Opportunistic Infections; Outcome; Perinatal; Protocols documentation; Puberty; Purpose; Quality of life; Research; Research Personnel; Resources; Site; Source; Time; Toxic effect; United States National Institutes of Health; Vaccine Therapy; Woman; antiretroviral therapy; body system; follow-up; in utero; infancy; neuropsychological

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. To describe late outcomes over time in relation to survival, growth, neurologic, and neuropsychological function, quality of life, organ system toxicity, metabolic disorders, development of oppotunistic 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 subject. This study will also attempt to determine if uninfected infants born to HIV-infected women demonstrate any short or long-term adverse clinical or laboratory effects due to exposure to antiretroviral therapy or immune therapy/vaccines in utero, the perinatal period, or early infancy. This is a perspective, longitudinal study for long term follow-up of perinatally HIV-exposed infants, children, and adolescents, and children with post-perinatally acquired infection followed at PACTG site regardless of whether they are enrolled in PACTG protocols. The purpose of this study is 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 immunilogical, and virologic parameters in HIV-infected infants, children and adolescents. This will also include evaluation of potential late outcomes, impact of puberty, and complications of antiretroviral and immune therapy received by the subject. Moreover, to determine if uninfected infants born to HIV-infected women demonstrate any short or long term adverse clinical or laboratory effects due to exposure to antiretroviral therapy or immune therapy/vaccines in utero, the perinatal period, or early infancy.

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。子项目及 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 对于中心来说，它不一定是研究者的机构。 描述 HIV 感染婴儿、儿童的生存、生长、神经系统和神经心理功能、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随时间的变化的晚期结果和青少年。这还将包括评估受试者接受的抗逆转录病毒和免疫治疗的潜在后期影响、青春期影响以及并发症。这项研究还将尝试确定艾滋病毒感染妇女所生的未感染婴儿是否会因在子宫内、围产期或婴儿早期接受抗逆转录病毒治疗或免疫治疗/疫苗而表现出任何短期或长期不良临床或实验室影响。 这是一项前瞻性纵向研究，针对围产期 HIV 暴露婴儿、儿童和青少年以及围产期后获得性感染的儿童进行长期随访，无论他们是否参加 PACTG 方案，均在 PACTG 中心进行随访。 本研究的目的是描述随着时间的推移，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的发展以及艾滋病毒的免疫学和病毒学参数相关的晚期结果- 受感染的婴儿、儿童和青少年。 这还包括评估潜在的晚期结果、青春期的影响以及受试者接受的抗逆转录病毒和免疫治疗的并发症。 此外，确定感染艾滋病毒的妇女所生的未感染婴儿是否因在子宫内、围产期或婴儿早期接受抗逆转录病毒治疗或免疫治疗/疫苗而表现出任何短期或长期不良临床或实验室影响。