Miami HIV/AIDS Clinical Therapeutic and Vaccine Trial Unit

描述（由申请人提供）：艾滋病毒/艾滋病仍然是一个主要的卫生保健问题，在美国和世界各地。迈阿密临床试验单位（CTU）作为艾滋病临床试验小组（ACTG）的成员和艾滋病毒疫苗治疗网络（HVTN）的申请成员，其长期目标是通过疫苗开发来阻止和逆转人类免疫缺陷病毒（HIV）疾病并预防感染，最终目标是治愈和预防HIV。为了实现这些目标，我们建议继续我们与ACTG网络的19年合作关系，并将我们的努力扩展到HVTN网络的疫苗研究开发的高优先领域。迈阿密CTU汇集了在设计和实施治疗性HIV临床研究、疫苗研究、预防行为研究以及开发、评估和实施用于评估治疗和预防干预措施的免疫学和病毒学参数方面具有广泛和长期经验的研究人员。迈阿密CTU建议建立一个完全整合的行政核心和临床研究中心，即迈阿密大学艾滋病临床研究中心（UM ACRU），因此还将建立一个目前正在运作的研究机构，该机构具有长期的专业知识，能够识别、招募和跟踪感染人群和感染艾滋病毒的高危人群，包括妇女、少数民族患者和注射吸毒者。凭借20年评估和跟踪HIV感染风险个体的经验，以及在治疗性临床试验方面的长期经验和专业知识，迈阿密CTU具有灵活性和能力，能够在开发的所有阶段进行多个临床研究项目，并能够快速响应不断发展的创新研究。迈阿密CTU的一个主要优势是其在治疗临床试验中经过验证的设计、实施和随访能力。迈阿密CTU将通过以下方式继续为艾滋病毒的治疗和预防做出贡献并扩大其努力：在艾滋病毒-1临床研究的设计和实施方面发挥领导作用;积极为ACTG和HVTN的科学议程做出贡献;在ACTG和HVTN的每个临床试验领域，在12个月内保持平均每月20名研究参与者的普查;提供扩大的临床能力，在ACTG和HVTN的每个临床试验领域招募、筛选、登记和随访不少于100名研究参与者，为期12个月;与艾滋病毒高危人群和南佛罗里达感染者合作并对其进行教育。拟议的临床试验和调查将促进我们对艾滋病毒/艾滋病的治疗和发病机理的了解，并导致改善艾滋病毒的护理和预防。 行政部门：

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: