Laboratory Center (LC): Microbicide Trials Network

描述（由申请人提供）：过去几年，在艾滋病预防领域取得了显著进展。局部杀微生物剂在使用替诺福韦凝胶的妇女中首次适度地证明了其有效性。在过去的六年里，杀微生物剂试验网络（MTN）为临床杀微生物剂基础设施的进一步研究奠定了基础。在接下来的7年里，MTN计划扩大用于艾滋病毒预防的药物和剂型，我们将把工作重点放在艾滋病毒感染高风险人群上。作为MTN的实验室中心（LC），我们将为MTN的科学议程提供实验室监督，以确保所有实验室符合良好的临床实验室规范。此外，MTN LC将与所有NIH赞助的HIV临床试验网络和NIH承包商合作，以协调实验室方法并最大限度地提高协议实施的效率。这将在MTN LC和相关临床试验单位/临床研究站点实验室之间建立明确的沟通渠道。其次，MTN LC将与MTN领导小组和统计与数据管理中心合作，确保MTN科学议程继续响应产品安全和预期产品功效的协议要求。为了完成我们的使命，MTN LC将依靠三个核心实验室：由Charlene Dezzutti博士领导的协议支持核心实验室。

DESCRIPTION (provided by applicant): The past few years have seen remarkable progress in the HIV prevention field. Topical microbicides have had their first, modest demonstration of efficacy in women using tenofovir gel. Throughout the last six years the Microbicide Trials Network (MTN) has laid a foundation of additional studies to gird the clinical microbicide infrastructure. Over the next seven years, the MTN plans to expand the drugs and dosage forms brought into HIV prevention and we will focus our efforts on populations that are at high risk for HIV acquisition. As the Laboratory Center (LC) for the MTN we will provide laboratory oversight for the MTN scientific agenda to ensure compliance of all laboratories to good clinical laboratory practice. Additionally, the MTN LC will work with all NIH-sponsored HIV clinical trial networks and NIH contractors to harmonize laboratory methods and maximize the efficiency of protocol implementation. This will develop clear lines of communication between the MTN LC and associated Clinical Trials Units/Clinical Research Sites laboratories. Secondly, the MTN LC will work with the MTN Leadership Group and Statistical and Data Management Center to ensure the MTN scientific agenda continues to be responsive to protocol requirements for product safety and anticipated product efficacy. To accomplish our mission, the MTN LC will rely on three Core Laboratories: the Protocol Support Core led by Dr. Charlene Dezzutti along with Drs. Lisa Rohan, Sharon Hillier and lan McGowan who will provide their expertise for product testing, site support, sexually transmitted disease diagnoses, mucosal flora monitoring, mucosal immunity, and systems biology; the Virology Core led by Dr. John Mellors and Dr. Urvi Parikh who will provide the daily oversight for the HIV endpoint and drug resistance testing - primary endpoints for our protocols; and the Pharmacology Core led by Drs. Craig Hendrix and Peter Anderson who will provide their expertise for analyte analysis and assay development and define how much drug reaches the target tissue/cells and how long it remains - critical questions for topical microbicide development. Together, this remarkable team will strive to bring to licensure a safe and effective topical microbicide. RELEVANCE: Despite over 30 years into the HIV epidemic, modest advances have been to help people protect themselves from getting infected. The work done by the Microbicide Trials Network will bring forward new drugs and new ways to use them to prevent people from getting HIV. To do this, work will be done by a group of dedicated scientists to make sure safe and potent products are tested.