Targeting High-Risk Women for HVTN and Microbicide Trials

针对高危女性进行 HVTN 和杀菌剂试验

• 批准号: 7344843
• 负责人: RICHARD M NOVAK
• 金额: $ 59.66万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 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 2013-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7344843
• 关键词: African American; Agreement; Area; Chicago; Clinic; Clinical Trials; Funding; HIV; HIV vaccine; High Risk Woman; Hospitals; Illinois; Incidence; Investigational Drugs; Laboratories; Leadership; Letters; Medical center; Microbicide Trials Network; Mucosal Immunity; Peripheral Blood Mononuclear Cell; Pharmaceutical Services; Principal Investigator; Process; Records; Research; Research Priority; Sampling; Services; Target Populations; Universities; Woman; clinical research site; hospital laboratories; microbicide; programs; vaccine effectiveness

DESCRIPTION (provided by applicant): University of Illinois at Chicago (UIC) Project WISH (Women Invested in Stopping HIV) is applying to become a Clinical Trials Unit. We are proposing that our organization be the only Clinical Research Site for his CTU. We are currently an HIV Vaccine Trial Unit for the HIV Vaccine Trials Network (HVTN) and are proposing to continue that relationship. A letter of commitment from the HVTN leadership accompanies this application. We are also proposing to participate in the Microbicide priority research area. We do not have a network affiliation or prior agreement for this activity. In addition to current participation in the HVTN, Project WISH participated in the HIVNET Clinical Trial 014. We also provided the highest risk women (including the seroconverters) for the VaxGen VAX004 trial with an HIV incidence of 3.3% for that trial. Approximately one third of the women and one third of the African Americans in that trial came from Project WISH. This unit is also engaged in NICHD-funded HIV mucosal immunity studies in this same target population and has been included in the HVTN's proposal to continue to investigate these issues as they relate to vaccine effectiveness. Given our access to the high-risk women, expansion of the program to include microbicide trials is appropriate. Project WISH is a free-standing research unit in the University of Illinois Medical Center. We have our own clinic which is dedicated solely to research. This clinic has several exam rooms, space for clinical trial records, and a small laboratory for the processing and storing of samples. The University of Illinois Hospital Investigational Drug Services provides pharmacy services and we have access to all of hospital laboratory services. The Principal Investigator has his own laboratory with hoods and storage facilities that are used for PBMC processing. ADMINISTRATIVE COMPONENT:

描述（由申请人提供）：伊利诺伊大学芝加哥大学项目愿望（投资于艾滋病毒的妇女）申请成为临床试验部门。我们建议我们的组织成为其CTU的唯一临床研究站点。我们目前是HIV疫苗试验网络（HVTN）的HIV疫苗试验单元，并提议继续这种关系。 HVTN领导层的承诺信伴随着此申请。我们还建议参与微生物剂优先研究领域。我们没有有关此活动的网络隶属关系或事先协议。除了目前参与HVTN外，项目愿望还参加了HIVNET临床试验014。我们还为VAXGEN VAX004试验提供了最高风险的妇女（包括血清发电机），该试验的HIV发病率为3.3％。在该审判中，大约三分之一的妇女和三分之一的非洲裔美国人来自项目愿望。该单位还参与了同一目标人群中NICHD资助的HIV粘膜免疫研究，并已包括在HVTN的提议中，以继续调查这些问题，因为它们与疫苗有效性有关。鉴于我们进入高风险妇女的访问，该计划的扩展以包括杀生型试验是合适的。项目愿望是伊利诺伊大学医学中心的独立研究部门。我们拥有自己的诊所，专门用于研究。该诊所设有几个检查室，用于临床试验记录的空间以及一个用于处理和存储样品的小实验室。伊利诺伊大学医院的研究药物服务提供药房服务，我们可以使用所有医院实验室服务。首席研究人员拥有自己的实验室，该实验室带有用于PBMC处理的引擎盖和存储设施。 管理组件：