CORE NICHD NETWORK CLINICAL SITE SUPPORT FOR IMPAACT RELATED STUDIES

背景和导言 Eunice Kennedy Shriver国家儿童健康和人类发展研究所（NICHD）为国际孕产妇儿童青少年艾滋病临床试验组（IMPAACT）提供临床试验场地。IMPAACT网络及其领导小组负责创建所有研究，方案和临床试验。这些活动的经费来自国家土著发展研究所赞助的赠款/合作协议。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。这包括为预防母婴传播进行艾滋病毒/艾滋病干预措施的临床试验。 1990年，NICHD开始与PACTG合作，以扩大NICHD临床试验中心/地点的临床试验可用性。通过这一合作，IMPAACT网络得以开展临床试验，以进一步评估抗逆转录病毒治疗剂、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，这种合作正在扩大到评估潜在的艾滋病毒治疗方法和疫苗。 范围和目标 本任务订单旨在为临床研究中心提供核心基础设施支持，包括实施IMPAACT网络方案的国内和国际临床中心的NICHD多中心网络。核心基础设施包括日常任务，以维持研究中心准备开展临床试验，以评价儿科、青少年和孕产妇患者人群中HIV感染多个方面的研究性治疗、诊断技术、预防策略、流行病学和自然史。

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.