Microbicide Trials Network

描述（由申请人提供）： 本申请的目的是建立核心领导小组和杀菌剂试验网络（MTN）的网络实验室。领导小组的目标是监督和协调一系列预防艾滋病毒的局部杀微生物剂临床试验。杀微生物剂试验网络的使命是通过开发和评价局部应用于粘膜表面时可减少艾滋病毒传播的产品，减少艾滋病毒的性传播。目标是对杀微生物剂的安全性和有效性进行科学上严格和道德上合理的临床试验，以支持这些产品的许可证发放。MTN CORE和网络实验室将总部设在匹兹堡，由Sharon Hillier博士（CORE）和Charlene Dezzutti博士（网络实验室）领导。核心对MTN的支持将通过匹兹堡与西雅图的华盛顿大学和洛杉矶的加州大学洛杉矶分校以及北卡罗来纳州的罗利的国际家庭健康组织的研究人员合作进行协调。网络实验室由比较评估核心、研究中心支持和诊断测试核心、病毒学戈尔、药理学核心和免疫学核心组成。MTN提出了15项新的临床试验组合，涵盖早期安全性和有效性研究。此外，MTN将负责指导两项正在进行的杀微生物剂研究，这两项研究是在HPTN 035和059下开发的。临床试验地点将设在美国和非洲。MTN将与其他DAIDS赞助的网络和国际上从事杀微生物剂研究的团体合作。

DESCRIPTION (provided by applicant): The objective of this application is to establish the CORE Leadership Group and a Network Laboratory for the Microbicide Trials Network (MTN). The objective of the Leadership Group is to provide oversight and coordination of a portfolio of clinical trials on topical microbicides for prevention of HIV. The mission of the Microbicide Trials Network is to reduce the sexual transmission of HIV through the development and evaluation of products which reduce the transmission of HIV when applied topically to mucosal surfaces. The goal is to conduct scientifically rigorous and ethically sound clinical trials of microbicide safety and effectiveness which will support licensure of these products. The MTN CORE and Network Laboratory will be headquartered in Pittsburgh under the direction of Dr. Sharon Hillier (CORE) and Dr. Charlene Dezzutti (Network Laboratory). CORE support for the MTN will be coordinated through Pittsburgh in collaboration with investigators at the University of Washington in Seattle and UCLA in Los Angeles, as well as Family Health International, in Raleigh North Carolina. The Network Laboratory is composed of a Comparative Assessment Core, a Site Support and Diagnostic Testing Core, a Virology Gore, a Pharmacology Core, and a Immunology Core. The MTN proposes a portfolio of 15 new clinical trials which span early safety to effectiveness studies. In addition, the MTN will assume direction for two ongoing microbicide studies which were developed under the HPTN, HPTN 035 and 059. Clinical trial sites will be located in the US and in Africa. The MTN will collaborate with other DAIDS sponsored networks and groups engaged in microbicide research internationally.