Emory- Duke- Orlando- CDC (EmDOC) Clinical Trials Unit

埃默里-杜克-奥兰多-CDC (EmDOC) 临床试验单位

• 批准号: 8609924
• 负责人: Jeffrey Lennox
• 金额: $ 251.89万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-01 至 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8609924
• 关键词: AIDS prevention; Address; Adolescent; Adult; Affect; American; Antibiotic Resistance; Area; Bacterial Drug Resistance; Botswana; Centers for Disease Control and Prevention (U.S.); Childhood; Clinical Research; Clinical Trials; Clinical Trials Network; Clinical Trials Unit; Comorbidity; Complex; Country; Development; Enrollment; Epidemic; HIV; HIV Infections; Health; Hepatitis; Immunology; Income; Infection; International; Kenya; Methods; Minority; National Institute of Allergy and Infectious Disease; Population; Prevention strategy; Principal Investigator; Research; Research Priority; Site; Tanzania; Thailand; Therapeutic; Tuberculosis; United States; Universities; Vaccines; Viral hepatitis; Woman; Work; disorder prevention; flexibility; human subject; improved; microbicide; prevent; prevention clinical trial; treatment strategy; tuberculosis treatment

DESCRIPTION (provided by the applicant): Through this application Emory University, Duke University, the Orlando Immunology Center, and the Centers for Disease Control and Prevention (CDC) are proposing an integration of eight existing, highly productive HIV research sites. The administrative core of the Emory, Duke, Orlando, CDC Clinical Trials Unit (EmDOC CTU) will be located at Emory University. The CTU will be led by three Principal Investigators: Carlos del Rio, Jeffrey Lennox, and Mark J. Mulligan. The CTU will include four Southeastern US research sites (2 located in Atlanta, one in Durham, and one in Orlando) and four international research sites (Botswana, Kenya, Tanzania, and Thailand). All of these sites are currently performing complex clinical trials in areas of the United States and internationally that are hard hit by the HIV epidemic, as well as by the concomitant epidemics of TB and viral hepatitis, and have access to diverse heavily affected populations. The Specific Aims of the Project are: 1. To contribute scientific expertise and human subject enrollment into studies that address these six key research areas-Adult HIV therapeutic strategies, including HIV cure, noninfectious comorbidities, and the infectious comorbidities of hepatitis and tuberculosis; Strategies to address HIV and HIV-associated infections in pediatric and maternal populations; Integrated HIV prevention strategies; Microbicide strategies to prevent HIV infection; Vaccines to prevent HIV infection; and Strategies to address antibacterial resistance. 2. To be a leading CTU for contributions of women, minorities and adolescents to support Network clinical trials, both domestically and in low and middle income countries. 3. To operate an efficient and flexible CTU that can respond rapidly to evolving research opportunities. 4. To participate in the development and implementation of the clinical research plans of all of the NIAID clinical research networks that are addressing the six priority research areas.

描述（由申请人提供）：通过本申请，埃默里大学、杜克大学、奥兰多免疫学中心和疾病控制和预防中心（CDC）提议整合8个现有的高产HIV研究中心。Emory，杜克，奥兰多，CDC临床试验部门（EmDOC CTU）的行政核心将位于Emory大学。CTU将由三名首席调查员领导：卡洛斯德尔里奥、杰弗里伦诺克斯和马克·J·穆里根。CTU将包括四个美国东南部研究中心（2个位于亚特兰大，一个位于达勒姆，一个位于奥兰多）和四个国际研究中心（博茨瓦纳，肯尼亚，坦桑尼亚和泰国）。所有这些研究中心目前都在美国和国际上进行复杂的临床试验， 受艾滋病毒流行病以及随之而来的结核病和病毒性肝炎流行病的严重打击，并能接触到各种严重受影响的人群。 该项目的具体目标是： 1.为解决这六个关键研究领域的研究提供科学专业知识和人类受试者招募-成人艾滋病毒治疗策略，包括艾滋病毒治愈，非感染性合并症，以及肝炎和结核病的感染性合并症;解决儿科和孕产妇人群中艾滋病毒和艾滋病毒相关感染的策略;综合艾滋病毒预防策略;预防艾滋病毒感染的杀微生物剂策略;预防艾滋病毒感染的疫苗;以及解决抗菌素耐药性的战略。 2.在妇女、少数民族和青少年的贡献方面成为领先的CTU，以支持国内和中低收入国家的网络临床试验。 3.运营一个高效灵活的CTU，能够快速响应不断变化的研究机会。 4.参与所有NIAID临床研究网络的临床研究计划的制定和实施，这些网络涉及六个优先研究领域。