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

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

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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.

背景和引言Eunice Kennedy Shriver国家儿童健康与人类发展研究所（NICHD）为国际母性小儿青少年艾滋病临床试验小组（Impaact）提供了临床试验地点。 Indaact网络及其领导力小组负责创建所有研究，方案和临床试验。这些活动是通过Niaid赞助的赠款/合作协议来资助的。 Incract网络是一个合作的机构，研究人员和其他合作者，主要致力于评估婴儿，儿童，青少年和孕妇的HIV感染及其相关症状及其相关症状和共同感染的潜在疗法。这包括艾滋病毒/艾滋病干预措施的临床试验，以预防母亲传播母亲。 1990年，NICHD开始与PACTG合作，以扩大NICHD临床试验中心/站点的临床试验可用性。这项合作使Incract网络的临床试验成为可能，以进一步评估抗逆转录病毒治疗剂，针对机会感染的其他疗法以及防止围产期HIV传播的干预措施。近年来，该合作正在扩大，以评估潜在的HIV治疗方法和疫苗。范围和目标该任务订单是在临床站点提供核心基础设施支持，其中包括进行不可行的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就绪的常规任务，以进行临床试验，以评估研究疗法，诊断技术，预防策略，流行病学和自然历史的小儿，青少年和母体患者种群的多个方面。