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: 8233176
• 负责人: CAROL NESEL
• 金额: $ 4113万
• 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/8233176
• 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、协调和管理临床中心的多地点网络，该网络对儿童、青少年和孕产妇患者群体的艾滋病毒感染和疾病的治疗、预防、诊断、流行病学和自然史进行研究。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的单一临床试验，以预防艾滋病毒感染儿童的感染。 1989-90 年，协调中心资助的临床试验中心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小组合作，开发和开展多项治疗儿童和妇女艾滋病毒感染及其并发症的临床试验，以及预防艾滋病毒母婴传播的干预措施。这项努力成功地延续至今。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地点，称为NICHD国内和国际儿科和孕产妇艾滋病毒临床试验网络（NICHD网络），已经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；以及欧洲儿科艾滋病治疗网络。 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一项比较不同婴儿抗逆转录病毒预防方案的研究，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。 （例如，母亲们直到临产时才被确认为艾滋病毒感染者）。该试验正在美国、拉丁美洲和南非进行。印度农村地区正在开展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业务研究。此外，认识到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，协调中心合同正在为 NICHD 国际站点开发计划 (NISDI) 提供资金。该倡议涉及对感染艾滋病毒的孕妇及其婴儿以及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.