CORE NICHD NETWORK CLINICAL SITE SUPPORT FOR IMPAACT RELATED STUDIES

核心 NICHD 网络临床站点支持影响相关研究

基本信息

批准号：
10792687
负责人：
BARBARA DRIVER
金额：
$ 242.04万
依托单位：
WESTAT, INC.
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-11-30 至 2023-11-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10792687
关键词：
AIDS clinical trial group Adolescent Anti-Retroviral Agents Charge Child Childhood Clinical Trials Collaborations Conduct Clinical Trials Diagnostic Procedure Epidemiology Evaluation Funding Grant HIV HIV Infections HIV therapy HIV/AIDS Infant Infrastructure Institution International International Maternal Pediatric Adolescent AIDS Clinical Trials Intervention Investigational Therapies Leadership National Institute of Allergy and Infectious Disease National Institute of Child Health and Human Development Natural History Opportunistic Infections Pregnant Women Prevention Prevention strategy Protocols documentation Readiness Research Personnel Site Symptoms Therapeutic Agents U-Series Cooperative Agreements Vaccines Vertical Disease Transmission clinical center clinical research site co-infection patient population perinatal HIV prevent targeted treatment transmission process young woman

项目摘要

BACKGROUND and INTRODUCTION The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) provides clinical trial sites to the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT). The IMPAACT network and its leadership group are in charge of the creation of all their studies, protocols, and clinical trials. These activities are funded through Grants/Cooperative agreements sponsored by NIAID. The IMPAACT Network is a cooperative group of institutions, investigators, and other collaborators mainly focused on evaluating potential therapies for HIV infection and its related symptoms and co-infections in infants, children, adolescents and pregnant women. This includes clinical trials of HIV/AIDS interventions for the prevention of mother to child transmission. In 1990 the NICHD began collaborating with the PACTG to expand clinical trial availability at NICHD clinical trial centers/sites. This collaboration made possible to conduct clinical trials by the IMPAACT Network to further evaluate antiretroviral therapeutic agents, other therapies targeted at opportunistic infections, and interventions to prevent perinatal HIV transmission. In recent years, the collaboration is expanding to evaluate potential HIV cure approaches and vaccines. SCOPE AND OBJECTIVES This task order is to provide Core infrastructure support at the clinical sites comprising the NICHD multi-site network of domestic and international clinical centers conducting IMPAACT Network protocols. Core infrastructure includes routine tasks for maintaining site readiness to conduct clinical trials for evaluation of investigational therapies, diagnostic techniques, prevention strategies, epidemiology and natural history of multiple aspects of HIV infection in pediatric, adolescent, and maternal patient populations.

背景和简介尤尼斯·肯尼迪·施赖弗国家儿童健康和人类发展研究所 (NICHD) 为国际孕产妇儿科青少年艾滋病临床试验组 (IMPAACT) 提供临床试验场所。 IMPAACT 网络及其领导小组负责创建所有研究、方案和临床试验。这些活动由 NIAID 赞助的赠款/合作协议资助。 IMPAACT 网络是一个由机构、研究人员和其他合作者组成的合作小组，主要致力于评估婴儿、儿童、青少年和孕妇艾滋病毒感染及其相关症状和合并感染的潜在疗法。这包括预防母婴传播艾滋病毒/艾滋病干预措施的临床试验。 1990 年，NICHD 开始与 PACTG 合作，扩大 NICHD 临床试验中心/场所的临床试验可用性。此次合作使得 IMPAACT 网络能够开展临床试验，以进一步评估抗逆转录病毒治疗药物、针对机会性感染的其他疗法以及预防围产期艾滋病毒传播的干预措施。近年来，合作范围正在扩大，以评估潜在的艾滋病毒治疗方法和疫苗。范围和目标该任务订单旨在为临床站点提供核心基础设施支持，这些临床站点包括执行 IMPAACT 网络协议的国内和国际临床中心的 NICHD 多站点网络。核心基础设施包括维持现场准备状态以进行临床试验的常规任务，以评估儿科、青少年和孕产妇患者群体中艾滋病毒感染的多个方面的研究疗法、诊断技术、预防策略、流行病学和自然史。