Microbicide Trials Network

描述(由申请人提供)： 本申请的目标是为杀微生物剂试验网络(MTN)建立核心领导小组和网络实验室。领导小组的目标是监督和协调用于预防艾滋病毒的外用杀菌剂的临床试验组合。杀微生物剂试验网络的任务是通过开发和评价局部应用于粘膜表面时减少艾滋病毒传播的产品来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、严格和合乎道德的临床试验，这将支持这些产品的许可。MTN核心和网络实验室的总部将设在匹兹堡，由Sharon Hillier博士(CORE)和Charlene Dezzutti博士(网络实验室)领导。对MTN的核心支持将通过匹兹堡与西雅图华盛顿大学和洛杉矶加州大学洛杉矶分校以及北卡罗来纳州罗利的家庭健康国际的调查人员合作进行协调。网络实验室由比较评估核心、现场支持和诊断测试核心、病毒学核心、药理学核心和免疫学核心组成。MTN提出了一系列15项新的临床试验，这些试验涵盖了早期的安全性和有效性研究。此外，MTN将指导HPTN下正在进行的两项杀微生物剂研究，HPTN 035和HPTN 059。临床试验地点将设在美国和非洲。MTN将与DAIDS赞助的其他网络和组织合作，在国际上从事杀微生物剂研究。

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.