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·施莱弗国家儿童健康和人类发展研究所（NICHD）的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，以继续开展目前的活动，实施和指导广泛的国内和国际研究活动，研究流行病学、临床表现、发病机制、传播、治疗、预防婴儿、儿童、青少年和妇女（孕妇和非孕妇）的艾滋病毒感染及其传染性和非传染性并发症。承包商将提供实施、维护、协调和管理临床中心多站点网络所需的所有必要服务、合格人员、材料、设备和设施，以开展当前和未来的上述参考研究的临床试验。数据协调中心将促进研究，以评价儿童、青少年和产妇患者群体中艾滋病毒感染和疾病以及其他高度优先感染的多个方面的研究疗法、诊断技术、预防战略、流行病学和自然史，以及基本合同及其单独备选方案工作说明中其他地方概述的任务。该合同是为国内和国际艾滋病网络临床试验数据协调中心的母婴传染病科（MPIDB）（前身为儿科、青少年和孕产妇艾滋病科）。