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: 8428980
• 负责人: CAROL NESEL
• 金额: $ 3409.57万
• 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/8428980
• 关键词: AIDS clinical trial group; Acquired Immunodeficiency Syndrome; Address; Adolescent; Adolescent Medicine Trials Network; Adult; American; Anti-Retroviral Agents; Breast Feeding; Caribbean region; Child; Child health care; Childhood; Clinical; Clinical Research; Clinical Trials; Clinical Trials Database; Clinical Trials Network; Collaborations; Conduct Clinical Trials; Contracts; Country; Data; Development; Diagnosis; Disease; Drug Kinetics; Epidemic; Epidemiologic Studies; Epidemiology; European; Funding; Future; Gender; Growth; HIV; HIV Infections; HIV vaccine; Human Development; Human immunodeficiency virus test; Immune; India; Individual; Infant; Infection; Infection prevention; Institutes; International; Intervention; Intravenous Immunoglobulins; Latin America; Long-Term Effects; Meta-Analysis; Metabolic; Morbidity - disease rate; Mothers; National Institute of Allergy and Infectious Disease; National Institute of Child Health and Human Development; Natural History; Nature; Neurodevelopmental Impairment; Neurologic; Observational Study; Opportunistic Infections; Pathogenesis; Patients; Perinatal; Pharmaceutical Preparations; Pharmacotherapy; Pregnancy; Pregnant Women; Prevention; Prophylactic treatment; Publications; Quality of life; Regimen; Research; Research Personnel; Resources; Risk; Rural; Safety; Site; South Africa; Staging; Therapeutic Uses; Time; Toxic effect; Training; Training and Infrastructure; Vertical Disease Transmission; Woman; antiretroviral therapy; clinical research site; experience; improved; infrastructure development; interest; neonate; patient population; pregnant; prevent; prophylactic; reconstitution; transmission process

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、协调和管理多地点临床中心网络，这些中心开展儿科艾滋病毒感染和疾病的治疗、预防、诊断、流行病学和自然史研究，青少年和孕产妇患者人群。该网络包括国内和国际临床站点。自1987年以来，NICHD通过合同机制为协调中心提供资金，最初用于进行静脉注射免疫球蛋白预防艾滋病毒感染儿童感染的单一临床试验。1989-90年，通过协调中心资助的临床试验地点开始与国家过敏和传染病研究所（NIAID）资助的儿科和成人艾滋病临床试验组合作，开发和进行多项临床试验，以治疗儿童和妇女的艾滋病毒感染及其并发症，以及预防母婴艾滋病毒传播的干预措施。这一努力成功地持续到现在。认识到儿童和孕产妇艾滋病毒流行的全球性，通过该合同资助的临床试验地点，称为NICHD国内和国际儿童和孕产妇艾滋病毒临床试验网络（NICHD网络），已扩大到包括拉丁美洲和加勒比地区的国际临床试验地点。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;由NICHD资助的青少年试验网络;以及儿科欧洲艾滋病治疗网络。 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进行和资助，而不是与其他网络合作。例如，协调中心的合同被用来资助一项研究，比较不同的婴儿抗逆转录病毒预防疗法，以防止怀孕期间未接受抗逆转录病毒治疗的艾滋病毒感染母亲所生婴儿的母婴传播。(For例如，母亲在分娩时才被确认为艾滋病毒感染者）。这项试验在美国进行，拉丁美洲和南非。目前正在印度农村进行一项业务研究，评价产前艾滋病毒检测和抗逆转录病毒预防措施的执行情况。此外，由于认识到需要进一步培训和发展，以提高拉丁美洲和加勒比进行临床试验的能力，特别是涉及试验性药物的临床试验，协调中心合同正在为NICHD国际场地开发倡议提供资金。这项倡议涉及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、这些研究的监管要求以及这些研究结果的分析和出版。最后，协调中心的合同还资助和进行跨临床试验分析（对个别患者数据的荟萃分析），以解决高度优先的艾滋病毒相关问题，如通过母乳喂养传播艾滋病毒的风险。 K.