Vanderbilt HIV Clinical Trials Unit

描述（由申请人提供）： 范德比尔特HIV临床试验部门（CTU）将由一个行政部门（AC）组成，支持HIV疫苗临床研究中心（疫苗CRS）和HIV治疗药物临床研究中心（治疗CRS）。长期目标是开发一种有效的疫苗来预防艾滋病毒感染，并为艾滋病毒感染患者提供新的和更好的治疗方法来控制艾滋病毒及其合并感染，以及通过最大限度地减少毒性和并发症来优化临床管理。AC将履行几项职能：管理/全面协调CTU和领导网络的关系以及财务管理;科学协调和战略规划;提供CRS之间共享的职能和资源;领导和支持社区关系。位于东南部流行病中心的位置，以及拟议调查人员和已经建立的研究地点的可靠记录，为这一申请提供了强有力的理由。“疫苗CRS w II延续了目前范德比尔特艾滋病毒疫苗试验单位的出色表现。范德比尔特在2005年5月提交的领导网络申请中被艾滋病毒疫苗试验网络领导列为首选网站。疫苗CRS将通过从所有风险人群中招募未感染的志愿者参与疫苗试验、扩大招募少数群体以及为网络提供经验丰富的试验执行和科学领导/方案制定人员，为拟议疫苗网络的临床研究计划中的每个具体目标做出重要贡献。治疗学CRS将继续当前范德比尔特成人艾滋病临床试验部门的模范表现。艾滋病临床试验将范德比尔特列为首选研究中心。集团领导在2005年5月提交的领导网络申请。该CRS将为拟议治疗研究网络的临床研究计划的大多数具体目标做出重要贡献。重点将是转化研究和药物开发，以及临床管理的优化。这将得益于Therapeutics CRS已被证明的招募HIV感染受试者的能力，进一步增加服务不足人群（包括少数民族和农村地区受试者）招募的强有力计划，已建立的高质量试验性能以及科学领导和成就的记录。公共卫生将受益于艾滋病毒感染的预防和更好的长期医疗。 行政部门：

DESCRIPTION (provided by applicant): The Vanderbilt HIV Clinical Trials Unit (CTU) will consist of an Administrative Component (AC), supporting the HIV Vaccine Clinical Research Site (Vaccine CRS) and the HIV Therapeutics Clinical Research Site (Therapeutics CRS). The long term objectives are to develop an effective: vaccine to prevent HIV infection and to provide HIV-infected patients with new and better therapies to control HIV and it's coinfections as well as to optimize clinical management by minimizing toxicities and complications. The AC will serve several functions: management/overall coordination of the CTU and Leadership Network relationships as well as financial management; scientific coordination and strategic planning; provision of functions and resources shared between the CRSs; leading and supporting community relationships. The location in the epicenter of the epidemic in the Southeast, as well as the proven track records of the proposed investigators and already established research sites provide a strong rationale for this application. "The Vaccine CRS w II continue the outstanding performance of the current Vanderbilt HIV Vaccine Trials Unit. Vanderbilt was included as a preferred site by the HIV Vaccine Trials Network Leadership in their May 2005 submission of a Leadership Network application. The Vaccine CRS will make important contributions to each of the specific aims in the clinical research plan of the proposed vaccine network by enrollment of uninfected volunteers from all risk groups into vaccine trials, expanded recruitment of minority populations, and provision of highly experienced personnel for trials performance and scientific leadership / protocol development for the Network. The Therapeutics CRS will continue the exemplary performance of the current Vanderbilt Adult AIDS Clinical Trials Unit. Vanderbilt was included as a preferred site by the AIDS Clinical Trials. Group Leadership in their May 2005 submission of a Leadership Network application. This CRS will make important contributions to most specific aims of the clinical research plan of the proposed treatment research network. The focus will be on translational research and drug development, as well as optimization of clinical management. This will be facilitated by the Therapeutics CRS's proven ability to enroll H V-infected subjects, a strong plan to further increase enrollment of underserved populations including minoriti3s and subjects from rural areas, established high-quality trials performance, and a record of scientific leadership and accomplishment. Public health will benefit from prevention and better long-term medical treatment of HIV infection. ADMINISTRATIVE COMPONENT: