NICHD INTERNATIONAL & DOMESTIC PEDIATRIC & MATERNAL HIV STUDIES DATA COORDINATING CENTER

尼奇国际

• 批准号: 8807750
• 负责人: CAROL NESEL
• 金额: $ 2945万
• 依托单位: WESTAT, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-01 至 2014-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8807750
• 关键词: AIDS clinical trial group; AIDS/HIV problem; Academic Medical Centers; Acquired Immunodeficiency Syndrome; Address; Adolescent; Adolescent Medicine; Adolescent Medicine Trials Network; Adult; Affect; Alabama; Anti-Retroviral Agents; Area; Argentina; Bacterial Infections; Baltimore; Biological; Boston; Brazil; Breast Feeding; California; Centers for Disease Control and Prevention (U.S.); Child; Child health care; Childhood; Clinical; Clinical Trials; Clinical Trials Network; Code; Collaborations; Colorado; Communicable Diseases; Comorbidity; Conduct Clinical Trials; Contractor; Contracts; Country; County Hospitals; Data Coordinating Center; Development; Diagnosis; Diagnostic; Diagnostic Procedure; Discipline of obstetrics; Disease; Drug Kinetics; Drug usage; Epidemic; Epidemiology; Equipment; European; Evaluation; Evaluation Research; Exposure to; Florida; Funding; Future; General Hospitals; Goals; Gynecology; HIV; HIV Infections; Health Sciences; Hepatitis; Hospitals; Human Development; Human Resources; IMPAACT; Infant; Infection; Institutes; International; International Maternal Pediatric Adolescent AIDS Clinical Trials; Intervention; Intravenous Immunoglobulins; Investigation; Investigational Therapies; Latin America; Long-Term Effects; Los Angeles; Malaria; Malnutrition; Maryland; Maternal Health; Medical center; Michigan; Modality; Morbidity - disease rate; Mothers; National Institute of Allergy and Infectious Disease; National Institute of Child Health and Human Development; Natural History; Nature; New York; Newborn Infant; Opportunistic Infections; Pathogenesis; Pediatric Hospitals; Perinatal; Perinatal Infection; Pharmaceutical Preparations; Population; Pregnancy; Pregnant Women; Prevention; Prevention strategy; Prophylactic treatment; Protocols documentation; Qualifying; Research; Research Activity; Research Design; Research Personnel; Resources; Safety; San Francisco; Services; Site; Specific qualifier value; Specimen; Therapeutic Agents; Time; Training and Infrastructure; Tuberculosis; United States National Institutes of Health; Universities; University Hospitals; Urban Hospitals; Vaccines; Washington; Woman; Work; base; clinical epidemiology; cooking; demographics; design; disorder prevention; drug abuse prevention; epidemiology study; fetal; flexibility; infrastructure development; interest; medical schools; patient population; pediatric AIDS; pediatric human immunodeficiency virus; pregnant; pregnant teen; prevent; programs; repository; response; transmission process; treatment center; vaccine evaluation; virtual

The Pediatric, Domestic, and Maternal AIDS (PAMA) Branch of the Center for Research for Mothers and Children (CRMC) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has a need for a Data Coordinating Center to continue the current activities of development, implementation, and direction of a wide range of domestic and international research activities for the study of epidemiology, clinical manifestations, pathogenesis, transmission, treatment, and prevention of HIV infection and its infectious and noninfectious complications in infants, children, adolescents, and women (pregnant and non-pregnant). The Contractor will furnish all the necessary services, qualified personnel, materials, equipment, and facilities needed to implement, maintain, coordinate, and manage a multi-site network of clinical centers to conduct current and future clinical trials of the preceding referenced research. The Data Coordinating Center will facilitate the research for the evaluation of investigational therapies, diagnostic techniques, prevention strategies, epidemiology and natural history of multiple aspects of HIV infection and disease and other high priority infections in pediatric, adolescent, and maternal patient populations, in addition to those tasks outlined elsewhere in the Statement of Work for the base contract and its separate options. This contract is for the Data Coordinating Center for domestic and international AID Network clinical trials for the Maternal and Pediatric Infectious Disease Branch (MPIDB) (formerly the Pediatric, Adolescent, and Maternal AIDS Branch). The NICHD Network conducts trials related to preventing and treating HIV infection and its complications in newborns, infants, children, adolescents, and pregnant women. Since 1987, has funded the NICHD Network, currently composed of 25 domestic sites in 13 states and territories and 9 international sites in Latin America, plus a Data Coordinating Center (DCC). The NICHD Network was established to conduct a single clinical trial evaluating the use of intravenous immunoglobulin (IVIG) prophylaxis for bacterial infections in 376 HIV-infected children. Over time, the NICHD Network has expanded with changes in the demographics of pediatric and maternal HIV infection. The number and type of clinical trial sites in the Network have changed, as well as the types of studies being done. In 1990, the NICHD Network began collaborating with the National Institute of Allergy and Infectious Diseases (NIAID)-funded Pediatric AIDS Clinical Trials Group (PACTG) to expand clinical trial availability at NICHD clinical trials sites. This collaboration made it possible to conduct clinical trials further evaluating primary antiretroviral therapeutic agents, other therapies targeted at opportunistic infections, and interventions to prevent perinatal HIV transmission. This NIAID-NICHD Network collaboration continues today with the NIAID-funded International Pediatric Maternal Adolescent AIDS Clinical Trials (IMPAACT) Group. The NICHD Network expanded to include sites with more expertise in obstetrics/gynecology and adolescent medicine, as well as international trial sites in Latin America. As the HIV epidemic has evolved, so has the research addressed by the NICHD Network. In populations of women and children, research gaps related to HIV-associated co-infections such as tuberculosis (TB), hepatitis, and malaria have emerged as HIV research has become increasingly global in nature. As a result, the NICHD Network and NIAID-funded IMPAACT Group broadened their focus to include TB, malaria, hepatitis, and investigation of vaccines to prevent HIV-related or other high-priority infectious diseases in children, adolescents, and pregnant women, in addition to treatment of HIV infection. In addition to its work with the IMPAACT Group described above, the NICHD Network collaborates with several other networks to design and conduct HIV-related trials. Funded by the NICHD, other NIH Institutes, and other agencies, these networks include (but are not limited to): ¿ Adult AIDS Clinical Trials Group ¿ Adolescent Medicine Trials Network for HIV/AIDS Interventions ¿ Pediatric European Network for Treatment of AIDS (PENTA) ¿ Centers for Disease Control and Prevention Tuberculosis Trials Consortium The NICHD Network relies on flexible contract mechanisms to initiate timely, high-priority initiatives in response to unanticipated research needs and to conduct planned studies with established protocols. In addition to a DCC, the NICHD Network uses a centralized specimen repository to store coded biological specimens from NICHD Network studies. This repository serves as a resource for Network and external investigators who are interested in answering specific questions related to HIV/AIDS.

尤尼斯·肯尼迪·施赖弗国家儿童健康和人类发展研究所 (NICHD) 母亲和儿童研究中心 (CRMC) 的儿科、家庭和孕产妇艾滋病 (PAMA) 分部需要一个数据协调中心来继续当前开展、实施和指导的一系列国内和国际研究活动，用于研究艾滋病毒感染及其传染性和传染性的流行病学、临床表现、发病机制、传播、治疗和预防婴儿、儿童、青少年和妇女（怀孕和非怀孕）的非感染性并发症 承包商将提供实施、维护、协调和管理多方面治疗所需的所有必要服务、人员、材料、设备和合格设施。临床中心网络，以对前述参考研究进行当前和未来的临床试验，数据协调中心将促进对艾滋病毒感染和艾滋病毒感染的多个方面的研究疗法、诊断技术、预防策略、流行病学和自然史的评估研究。除了基本合同工作说明书及其单独选项中概述的任务之外，该合同还适用于国内和国际援助数据协调中心。孕产妇和儿童传染病科 (MPIDB)（以前的儿科、青少年和孕产妇艾滋病科）的网络临床试验。 NICHD 网络在新生儿、婴儿、儿童、青少年和孕妇中开展与预防和治疗 HIV 感染及其并发症相关的试验，自 1987 年以来一直资助 NICHD 网络，目前由 13 个州和地区的 25 个国内站点和 9 个站点组成。拉丁美洲的国际站点，以及数据协调中心 (DCC)。 NICHD 网络的建立是为了开展一项临床试验，评估静脉注射免疫球蛋白 (IVIG) 在 376 名 HIV 感染儿童中预防细菌感染的效果。随着时间的推移，NICHD 网络随着儿科和孕产妇 HIV 感染人口统计的变化而不断扩大。网络中临床试验地点的数量和类型以及正在进行的研究类型都发生了变化。 1990 年，NICHD 网络开始与国家过敏和传染病研究所 (NIAID) 资助的儿科艾滋病临床试验小组 (PACTG) 合作，扩大 NICHD 临床试验地点的临床试验可用性。这种合作使临床试验的开展成为可能。进一步评估主要抗逆转录病毒治疗药物、针对机会性感染的其他疗法以及预防围产期艾滋病毒传播的干预措施。NIAID-NICHD 网络合作今天仍在继续。 NIAID 资助的国际儿科孕产妇青少年艾滋病临床试验 (IMPAACT) 小组。 NICHD 网络扩大到包括在妇产科和青少年医学方面拥有更多专业知识的站点，以及拉丁美洲的国际试验站点。 随着艾滋病毒流行的发展，NICHD 网络针对妇女和儿童群体的研究也在不断发展，与艾滋病毒相关的合并感染（如结核病 (TB)、肝炎和疟疾）相关的研究空白也随着艾滋病毒研究而出现。因此，NICHD 网络和 NIAID 资助的 IMPAACT 小组将其关注范围扩大到包括结核病、疟疾、肝炎以及预防艾滋病毒相关或其他疾病的疫苗研究。除了治疗艾滋病毒感染外，儿童、青少年和孕妇的高度优先传染病。 除了与上述 IMPAACT 小组的合作外，NICHD 网络还与其他几个网络合作设计和进行 HIV 相关试验，这些试验由 NICHD、其他 NIH 研究所和其他机构资助，这些网络包括（但不限于）。到）： ¿成人艾滋病临床试验组 ¿艾滋病毒/艾滋病干预青少年医学试验网络 ¿欧洲儿科艾滋病治疗网络 (PENTA) ¿疾病控制和预防中心结核病试验联盟 NICHD 网络依靠灵活的合同机制来启动及时、高优先级的举措，以满足意外的研究需求，并按照既定的协议进行有计划的研究。 除了 DCC 之外，NICHD 网络还使用一个集中样本存储库来存储来自 NICHD 网络研究的编码生物样本，该存储库为有兴趣回答与艾滋病毒/艾滋病相关的特定问题的网络和外部研究人员提供资源。