Vanderbilt HIV Clinical Trials Unit

描述(由申请人提供)： 范德比尔特艾滋病毒临床试验股(CTU)将由一个行政部门(AC)组成，为艾滋病毒疫苗临床研究网站(Vaccine CRS)和艾滋病毒治疗临床研究网站(Treateutics CRS)提供支持。长期目标是开发一种有效的疫苗来预防艾滋病毒感染，为艾滋病毒感染患者提供新的更好的治疗方法来控制艾滋病毒及其合并感染，并通过将毒性和并发症降至最低来优化临床管理。咨询委员会将履行几项职能：管理/全面协调职工盟和领导网络关系以及财务管理；科学协调和战略规划；提供社区服务中心之间共享的职能和资源；领导和支持社区关系。位于东南部疫情中心的位置，以及拟议的调查人员和已经建立的研究地点已证明的跟踪记录，为这一申请提供了强有力的理由。Vaccine CRS w II延续了目前Vanderbilt HIV疫苗试验部门的出色表现。在2005年5月提交的领导力网络申请中，范德比尔特被艾滋病毒疫苗试验网络领导层列为首选地点。疫苗研究中心将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，包括招募来自所有风险群体的未受感染的志愿者参加疫苗试验，扩大少数群体的招募，并为网络的试验性能和科学领导/方案开发提供经验丰富的人员。Treateutics CRS将继续目前范德比尔特成人艾滋病临床试验单位的模范表现。范德比尔特被艾滋病临床试验列为首选地点。集团领导力在2005年5月提交的领导力网络申请中。这一CRS将对拟议的治疗研究网络的临床研究计划的最具体目标做出重要贡献。重点将放在转化研究和药物开发上，以及临床管理的优化上。这将受到以下因素的推动：Treateutics CRS已被证明有能力招募HIV感染的受试者，进一步增加包括少数族裔和来自农村地区的受试者在内的未得到充分服务的人群的登记的强有力计划，已建立的高质量试验业绩，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。 管理组件：

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: