Targeting High-Risk Women for HVTN and Microbicide Trials

描述（由申请人提供）：伊利诺伊大学芝加哥分校（UIC）项目WISH（妇女投资于阻止艾滋病毒）正在申请成为临床试验单位。我们提议让我们的组织成为他的CTU唯一的临床研究基地。我们目前是艾滋病毒疫苗试验网络（HVTN）的艾滋病毒疫苗试验单位，并建议继续这种关系。该申请附有HVTN领导层的承诺函。我们还建议参与杀菌剂优先研究领域。我们没有网络隶属关系，也没有事先协议。除了目前参与HVTN外，WISH项目还参与了艾滋病毒网络临床试验014。我们还为VaxGen VAX004试验提供了最高风险的妇女（包括血清转换者），该试验的艾滋病毒发病率为3.3%。试验中大约三分之一的女性和三分之一的非裔美国人来自WISH项目。该单位还参与由联合国儿童基金会资助的针对同一目标人群的艾滋病毒粘膜免疫研究，并已列入HVTN关于继续调查与疫苗有效性有关的这些问题的建议。鉴于我们能接触到高危妇女，扩大项目包括杀微生物剂试验是合适的。WISH项目是伊利诺斯大学医学中心的一个独立研究单位。我们有自己的诊所，专门用于研究。这个诊所有几个检查室，临床试验记录的空间，以及一个处理和储存样品的小实验室。伊利诺伊大学医院研究药物服务提供药房服务，我们可以使用所有的医院实验室服务。首席研究员有自己的实验室，有用于PBMC处理的通风柜和存储设施。

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: