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.

Eunice Kennedy Shriver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）分支需要一个数据协调中心，以继续开展当前的活动，开发、实施和指导广泛的国内和国际流行病学研究活动，临床表现，发病机制，传播，治疗和预防艾滋病毒感染及其感染性和非感染性并发症的婴儿，儿童，青少年和妇女（孕妇和非孕妇）。承包商将提供实施、维护、协调和管理多地点临床中心网络所需的所有必要服务、合格人员、材料、设备和设施，以进行前述参考研究的当前和未来临床试验。数据协调中心将促进研究，以评价儿科、青少年和孕产妇患者人群中HIV感染和疾病以及其他高优先级感染的多个方面的试验性治疗、诊断技术、预防策略、流行病学和自然史，以及基础合同及其单独选项的工作说明书中其他地方概述的任务。本合同适用于国内和国际艾滋病网络孕产妇和儿童传染病分支（MPIDB）临床试验数据协调中心（原儿科、青少年和孕产妇艾滋病分支）。 NICHD网络开展与预防和治疗新生儿、婴儿、儿童、青少年和孕妇艾滋病毒感染及其并发症有关的试验。自1987年以来，一直为NICHD网络提供资金，该网络目前由13个州和地区的25个国内站点和拉丁美洲的9个国际站点以及一个数据协调中心组成。 NICHD网络的建立是为了进行一项单一的临床试验，评估静脉注射免疫球蛋白（IVIG）预防376名艾滋病毒感染儿童的细菌感染。随着时间的推移，NICHD网络随着儿科和孕产妇艾滋病毒感染人口统计学的变化而扩大。该网络中临床试验地点的数量和类型以及正在进行的研究的类型都发生了变化。 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组（PACTG）合作，以扩大NICHD临床试验地点的临床试验可用性。通过这种合作，得以开展临床试验，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网络的合作今天继续与NIAID资助的国际儿科孕产妇青少年艾滋病临床试验（IMPAACT）小组合作。 NICHD网络扩大到包括在妇产科和青少年医学方面具有更多专业知识的研究中心，以及拉丁美洲的国际试验中心。 随着艾滋病毒流行病的演变，NICHD网络所处理的研究也在演变。在妇女和儿童群体中，随着艾滋病毒研究日益全球化，与艾滋病毒相关的合并感染（如结核病、肝炎和疟疾）相关的研究空白已经出现。因此，NICHD网络和NIAID资助的IMPAACT小组扩大了其重点，包括结核病、疟疾、肝炎和疫苗研究，以预防儿童、青少年和孕妇中的艾滋病毒相关或其他高度优先传染病，以及艾滋病毒感染的治疗。 除了与上述IMPAACT小组合作外，NICHD网络还与其他几个网络合作，设计和开展艾滋病毒相关试验。这些网络由NICHD、其他NIH研究所和其他机构资助，包括（但不限于）： 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 欧洲艾滋病治疗儿科网络（PENTA） 美国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，及时启动高优先级倡议，以应对意外的研究需求，并根据既定协议进行计划研究。 除了DCC之外，NICHD网络还使用集中式标本库来存储NICHD网络研究中的编码生物标本。该资料库是网络和外部调查人员的一个资源，他们有兴趣回答与艾滋病毒/艾滋病有关的具体问题。