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

• 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
• 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

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.

背景和介绍美国国家儿童健康和人类发展研究所（NICHD）为国际母婴青少年艾滋病临床试验组（IMPAACT）提供临床试验点。impact网络及其领导小组负责所有研究、协议和临床试验的创建。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、调查人员和其他合作者组成的合作小组，主要侧重于评估婴儿、儿童、青少年和孕妇中艾滋病毒感染及其相关症状和合并感染的潜在治疗方法。这包括预防母婴传播的艾滋病毒/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/地点的临床试验可用性。这一合作使IMPAACT网络开展临床试验成为可能，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治疗方法以及预防围产期艾滋病毒传播的干预措施。近年来，该合作正在扩大，以评估潜在的艾滋病毒治愈方法和疫苗。