NICHD INTERNATIONAL & DOMESTIC PEDIATRIC & MATERNAL HIV STUDIES COORDINATING CTR

尼奇国际

• 批准号: 8659895
• 负责人: CAROL NESEL
• 金额: $ 3091.9万
• 依托单位: WESTAT, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-10-15 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8659895
• 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国家儿童健康与人类发展研究所（NICHD）的母亲和儿童研究中心（CRMC）的小儿，家庭和孕产妇（PAMA）分支机构（NICHD）需要一个数据协调中心，以继续进行当前的发展，实施和国际研究活动的广泛范围的发展，并在国内研究活动中进行了范围，并涉及研究范围的范围，以实现研究和国际研究，并进行了研究，并涉及研究范围的范围，以临床和国际研究的范围传播，并始终如一地传播，并将其传播范围传播，并且始终如一地传播。艾滋病毒感染及其在婴儿，儿童，青少年和妇女（怀孕和非怀孕）中的感染和非感染并发症。承包商将提供所有必要的服务，合格的人员，材料，设备和设施，以实施，维护，协调和管理多站点的临床中心网络，以对上述参考研究进行当前和未来的临床试验。数据协调中心将支持研究研究疗法，诊断技术，预防策略，流行病学和自然历史的艾滋病毒感染和疾病的多个方面的自然历史以及其他在其他方面涉及基本合同的陈述的儿科，青少年和母体患者人群中的其他高优先感染，此外还包括这些任务。该合同是针对孕产妇和小儿传染病分支（MPIDB）（以前是儿科，青少年和孕产妇艾滋病分支）的国内和国际援助网络数据协调中心临床试验。 NICHD网络进行了与预防和治疗艾滋病毒感染及其在新生儿，婴儿，儿童，青少年和孕妇的并发症有关的试验。自1987年以来，已经为NICHD网络提供了资金，该网络目前由13个州和地区的25个国内遗址组成，以及拉丁美洲的9个国际遗址，以及一个数据协调中心（DCC）。 建立了NICHD网络，以进行单个临床试验，该试验评估了376名HIV感染儿童中静脉免疫球蛋白（IVIG）预防性细菌感染的使用。随着时间的流逝，NICHD网络随着儿科和孕妇感染的人口统计的变化而扩大。网络中临床试验地点的数量和类型已经改变，以及正在进行的研究类型。 1990年，NICHD网络开始与国家过敏和传染病研究所（NIAID）资助的小儿艾滋病临床试验小组（PACTG）合作，以扩大NICHD临床试验网站的临床试验可用性。这项合作使得进行临床试验进一步评估原发性抗逆转录病毒治疗剂，针对机会感染的其他疗法以及防止围产期HIV传播的干预措施。 NIAID-NICHD网络的合作始于NIAID资助的国际小儿孕产妇艾滋病临床试验（Impaact）小组。 NICHD网络扩展到包括具有更多专业知识的妇产科和青少年医学以及拉丁美洲的国际试验网站的网站。 随着HICHD网络和NIAID资助的Inmact群体扩大了关注，包括结核病，疟疾，肝炎和疟疾，随着HIV研究的开始越来越全球性。除了治疗HIV感染外，还研究了儿童，青少年和孕妇的疫苗，以防止儿童，青少年和孕妇与HIV相关或其他高优先感染疾病。 除了与上述不可行的小组的工作外，NICHD网络还与其他几个网络合作设计和进行与HIV相关的试验。这些网络由NICHD，其他NIH机构和其他机构资助，包括（但不限于）： �成人艾滋病临床试验组 „艾滋病毒/艾滋病干预措施的青少年医学试验网络 �小儿欧洲艾滋病治疗网络（PENTA） »疾病控制与预防结核病中心财团 NICHD网络依靠灵活的合同机制来启动及时，高优先级的计划，以响应意外的研究需求，并使用既定协议进行计划的研究。 除DCC外，NICHD网络还使用集中式标本存储库来存储NICHD网络研究的编码生物样品。该存储库是有兴趣回答与艾滋病毒/艾滋病有关的特定问题的网络和外部调查人员的资源。