PEDIATRIC AND MATERNAL HIV STUDIES COORDINATING CENTER

儿科和孕产妇艾滋病毒研究协调中心

• 批准号: 7789163
• 负责人: CAROL NESEL
• 金额: $ 4087.37万
• 依托单位: WESTAT, INC.
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2012-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7789163
• 关键词: PEDIATRIC; MATERNAL; HIV; STUDIES; COORDINATING

The National Institute of Child Health and Human Development (NICHD) Domestic and International Pediatric and Maternal HIV Studies Coordinating Center (¿Coordinating Center¿) contract provides logistical, technical, and administrative support to maintain, coordinate, and manage a multi-site network of clinical centers conducting research on treatment, prevention, diagnosis, epidemiology, and natural history of HIV infection and disease in pediatric, adolescent, and maternal patient populations. The network includes both domestic and international clinical sites. The NICHD has funded the Coordinating Center through a contract mechanism since 1987, initially for the conduct of a single clinical trial of intravenous immune globulin to prevent infections in HIV-infected children. In 1989-90, the clinical trials sites funded through the Coordinating Center began collaboration with the pediatric and adults AIDS Clinical Trials Groups funded by the National Institute of Allergy and Infectious Diseases (NIAID) for developing and conducting multiple clinical trials to treat HIV infection and its complications in children and women as well as interventions to prevent mother to child HIV transmission. This effort has successfully continued to the present. In recognition of the global nature of the pediatric and maternal HIV epidemic, the clinical trials sites funded through the contract, called the NICHD Domestic and International Pediatric and Maternal HIV Clinical Trial Network (NICHD Network), have expanded to include international clinical trials sites in Latin America and the Caribbean. The NICHD Network currently collaborates with multiple clinical trials networks, including adult and pediatric networks funded by NIAID; the Adolescent Trials Network funded by NICHD; and the Pediatric European Network for Treatment of AIDS. The Coordinating Center contract also is used to fund clinical trials that are of specific interest to NICHD and that are completely conducted and funded solely through the contract and not with other Networks. For example, the Coordinating Center contract is used to fund a study comparing different infant antiretroviral prophylaxis regimens to prevent mother to child transmission in infants born to HIV-infected mothers who have not received antiretroviral therapy during pregnancy. (For example, the mothers were not dentified as HIV-infected until they presented in labor). This trial is being conducted in the U.S., Latin America and South Africa. An operational study evaluating implementation of antenatal HIV testing and antiretroviral prophylaxis is being conducted in rural India. Additionally, in recognition of a need for further training and development to increase Latin American and Caribbean capacity for the conduct of clinical trials, particularly those involving experimental drugs, the Coordinating Center contract is funding the NICHD International Site Development Initiative (NISDI). This initiative involves the conduct of two observational studies of HIV-infected pregnant women and their infants and HIV-infected children. The studies incorporate training of international investigators in the conduct of clinical studies, regulatory requirements for such studies, and the analysis and publication of results of such studies. Finally, the Coordinating Center contract also funds and conducts cross-clinical trial analyses (meta-analysis of individual patient data) to address high priority HIV-related issues, such as risk of HIV transmission through breastfeeding. k.

国家儿童健康和人类发展研究所（NICHD）国内和国际儿科和孕产妇艾滋病毒研究协调中心（“协调中心”）合同提供后勤、技术和行政支持，以维护、协调和管理一个多站点网络NICHD 资助了针对儿科、青少年和孕产妇患者群体的 HIV 感染和疾病的治疗、预防、诊断、流行病学和自然史研究的临床中心。协调中心自1987年以来通过合同机制，最初用于进行单一的静脉注射免疫球蛋白临床试验，以预防感染艾滋病毒的儿童的感染。1989-90年，通过协调中心合作资助的临床试验地点开始于儿科。由国家过敏和传染病研究所 (NIAID) 资助的艾滋病临床试验小组，旨在开发和开展多项治疗儿童和成人艾滋病毒感染及其并发症的临床试验认识到儿科和孕产妇艾滋病毒流行的全球性，通过合同资助的临床试验中心被称为 NICHD 国内和儿童感染中心。国际儿科和孕产妇艾滋病毒临床试验网络（NICHD 网络）已扩展到包括拉丁美洲和加勒比地区的国际临床试验站点。NICHD 网络目前与多个临床试验网络合作，包括由 NIAID 资助的成人和儿科网络；审判网络由 NICHD 和欧洲儿科艾滋病治疗网络资助。 协调中心合同还用于资助 NICHD 特别感兴趣的临床试验，这些临床试验完全通过合同而不是与其他网络进行和资助。例如，协调中心合同用于资助比较不同网络的研究。婴儿抗逆转录病毒预防方案，以防止感染艾滋病毒的母亲在怀孕期间未接受抗逆转录病毒治疗所生的婴儿（例如，母亲未被确定为）。这项试验正在美国、拉丁美洲和南非进行，一项评估产前艾滋病毒检测和抗逆转录病毒预防措施实施情况的操作性研究正在印度农村进行。由于需要进一步培训和发展，以提高拉丁美洲和加勒比地区进行临床试验的能力，特别是涉及实验药物的临床试验，协调中心合同正在资助 NICHD 国际站点开发计划（NISDI）。对感染艾滋病毒的孕妇及其婴儿和感染艾滋病毒的儿童进行两项观察性研究，这些研究包括对国际研究人员进行临床研究的培训、此类研究的监管要求以及此类研究结果的分析和发布。最后，协调中心合同还资助并进行跨临床试验分析（个体患者数据的荟萃分析），以解决与艾滋病毒相关的高度优先问题，例如通过母乳喂养传播艾滋病毒的风险。 k.