Miami HIV/AIDS Clinical Therapeutic and Vaccine Trial Unit

迈阿密艾滋病毒/艾滋病临床治疗和疫苗试验中心

• 批准号: 8010176
• 负责人: Margaret A Fischl
• 金额: $ 123.39万
• 依托单位: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-12 至 2013-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8010176
• 关键词: AIDS clinical trial group; Acquired Immunodeficiency Syndrome; Area; Behavioral; Caring; Censuses; Clinical; Clinical Research; Clinical Trials; Clinical Trials Unit; Development; Enrollment; Evaluation; Florida; Goals; HIV; HIV vaccine; HIV-1; Healthcare; Immunologics; Individual; Infection prevention; Injecting drug user; Investigation; Lead; Leadership; Minority; Participant; Pathogenesis; Patients; Phase; Population; Prevention; Preventive Intervention; Recruitment Activity; Research; Research Personnel; Research Project Grants; Risk; Therapeutic; Therapeutic Clinical Trial; Therapeutic Intervention; Universities; Vaccine Research; Vaccines; Virus Diseases; Woman; Work; clinical research site; design; experience; flexibility; follow-up; high risk; improved; innovation; member; prevent; research and development; research facility; therapeutic vaccine; vaccine development

DESCRIPTION (provided by applicant): HIV/AIDS remains a major health care problem both in the U.S. and throughout the world. The long term goals of the Miami Clinical Trials Unit (CTU), as a member of the AIDS Clinical Trials Group (ACTG) and as an applying member for the HIV Vaccine Treatment Network (HVTN), are to arrest and reverse human immunodeficiency virus (HIV) disease and to prevent infection through vaccine development, with the ultimate objective of curing and preventing HIV. To achieve these goals, we propose to continue our 19 year affiliation with the ACTG Network and to expand our efforts into the high priority area of Vaccine Research Development with the HVTN Network. The Miami CTU brings together investigators with broad and long standing experience in the design and conduct of therapeutic HIV clinical studies, vaccine studies, in prevention behavioral studies, and in the development, evaluation and implementation of immunologic and virologic parameters for the assessment of therapeutic and prevention interventions. The Miami CTU proposes a fully integrated Administrative Core and Clinical Research Site, the University of Miami AIDS Clinical Research Unit (UM ACRU), and therefore will also bring a currently functioning research facility with long-standing expertise and the ability to identify, recruit and follow an infected population and a high risk population for the acquisition of HIV that includes women, minority patients, and injection drug users. With 20 years experience in assessing and following at risk individuals for HIV infection, and the long standing experience and expertise in therapeutic clinical trials, the Miami CTU brings the flexibility and capability to conduct multiple clinical research projects in all phases of development with the ability to rapidly respond to evolving and innovative research. A major strength of the Miami CTU is its proven design, implementation and follow-up capabilities in therapeutic clinical trials. The Miami CTU will continue to contribute and expands its efforts in the treatment and prevention of HIV by: leadership in the design and conduct of HIV-1 clinical studies; actively contributing to the scientific agenda of the ACTG and the HVTN; maintain an average monthly census of 20 study participates over a 12-month period in each clinical trials area of the ACTG and HVTN; provide an expanded clinical capacity to recruit, screen, enroll, and follow no less than 100 study participants over a 12-month period in each clinical trials areas of the ACTG and HVTN; and work with and educate those at risk for HIV and those infected in South Florida. The proposed clinical trials and investigations will advance our understanding of the treatment and pathogenesis of HIV/AIDS, and lead to improved care and prevention of HIV. ADMINISTRATIVE COMPONENT:

描述（由申请人提供）：艾滋病毒/艾滋病在美国和全世界仍然是一个重大的医疗保健问题。作为艾滋病临床试验组（ACTG）的成员以及作为HIV疫苗治疗网络（HVTN）的申请成员，迈阿密临床试验单元（CTU）的长期目标是逮捕和逆转人类免疫缺陷病毒（HIV）疾病（HIV）疾病，并通过疫苗开发，并防止疫苗开发，并具有最终的治疗疗法和预防HIV的疫苗感染。为了实现这些目标，我们建议继续我们与ACTG网络的19年隶属关系，并将我们的精力扩展到HVTN网络的疫苗研究开发的高优先级领域。迈阿密CTU汇集了在治疗性HIV临床研究，疫苗研究，预防行为研究以及免疫学和病毒学参数的开发，评估和实施治疗和预防措施中，在设计和行为方面具有广泛和长期经验的研究人员。迈阿密CTU提出了一个完全集成的行政核心和临床研究网站，迈阿密艾滋病大学临床研究部门（UM ACRU），因此还将带来一家具有长期专业知识的目前运转良好的研究机构，并能够识别，招募和遵循感染人群，并遵循感染人群以及妇女，少数族裔患者（包括妇女，少数族裔患者）的风险人群，以及较高的风险人群。迈阿密CTU具有20年评估和关注艾滋病毒感染的风险个人的经验，以及治疗性临床试验的长期经验和专业知识，具有在发展的所有阶段进行多个临床研究项目的灵活性和能力，具有快速响应不断发展和创新研究的能力。迈阿密CTU的主要优势是其在治疗性临床试验中已久经考验的设计，实施和随访功能。迈阿密CTU将继续为艾滋病毒的治疗和预防做出贡献和扩大努力：在HIV-1临床研究的设计和行为方面的领导力；积极贡献ACTG和HVTN的科学议程；在ACTG和HVTN的每个临床试验区域中，维持20个研究的平均每月普查将在12个月内参加；在ACTG和HVTN的每个临床试验区域中，提供了扩大的临床能力，以在12个月的时间内招募，筛查，注册和关注不少于100名研究参与者；并与患有艾滋病毒的风险和在南佛罗里达州感染的人一起工作并教育。提出的临床试验和研究将提高我们对HIV/AIDS的治疗和发病机理的理解，并改善HIV的护理和预防。 管理组件：