LC: HIV PREVENTION TRIALS NETWORK

项目总结 拥有20年的经验和出色的业绩记录，艾滋病毒预防试验网络 (HPTN)实验室中心(LC)处于支持2020年及以后HPTN的最佳位置。作为该计划的一部分 在HPTN领导小组的领导下，HPTN LC将帮助制定网络的科学议程。HPTN LC将负责监督 研究现场的实验室活动；执行质量保证/质量控制(QA/QC)和专门测试 用于HPTN方案；评估和验证用于HPTN研究的分析方法；开发新的分析方法以实现 研究目标；并进行与艾滋病毒预防相关的辅助研究。HPTN LC有一个管理 核心、一个礼宾业务核心和五个实验室核心(病毒学、药理学、联合感染、毒理学、 免疫学)。HPTN LC还设有早期产品开发工作组和 护理点测试和远程技术。HPTN LC拥有支持HIV的丰富经验 美国(美国)、拉丁美洲、非洲和亚洲的议定书，以及最近在东欧开展的工作。这个 HPTN LC包括七名具有支持HPTN研究的&gt；100年经验的协议专家。 HPTN LC领导了协调其他网络和组织的实验室程序的努力，以及 与学术、政府和行业合作伙伴广泛合作。HPTN LC已支持 评估艾滋病毒预防的生物医学、行为和结构性干预措施的方案，通常在 在广泛的背景和场地中进行组合。这包括先锋研究、观察性研究和 第一阶段、第二阶段和第三阶段临床试验，向未感染艾滋病毒的人和感染艾滋病毒的人提供干预措施 个人、夫妇、队列和社区。HPTN研究人群包括青少年、女性、男性 与男性、变性女性、注射吸毒者和其他高危人群发生性关系，并进行了一些试验 招募40,000名参与者。HPTN LC在研究新药下进行了大量研究 (IND)申请美国食品和药物管理局(FDA)。HPTN LC的质量管理团队包括 监管事务官员，负责确保遵守机构、州、联邦和其他法规 要求。根据新的奖项，HPTN将评估用于艾滋病毒暴露前预防的新产品， 包括新药、新的给药系统、多用途技术和广谱中和抗体； HPTN还将进行综合战略研究，将生物医学和社会行为相结合 艾滋病毒预防干预措施。HPTN LC的具体目标是：目标1：提供领导、专业知识、 目标2：支持现场实验室，确保高PTN的质量 实验室结果；和目标3：通过化验开发和生物医学促进艾滋病毒预防科学 研究。一个强大而有效的HPTN LC在HPTN中尤为重要，因为它具有广阔的国际 艾滋病毒预防试验的范围、多样性和复杂性。这一奖项将使HPTN能够继续其使命 确定有效的艾滋病毒预防战略，以帮助结束艾滋病毒/艾滋病的流行。

PROJECT SUMMARY With 20 years of experience and an outstanding record of performance, the HIV Prevention Trials Network (HPTN) Laboratory Center (LC) is optimally positioned to support the HPTN in 2020 and beyond. As part of the HPTN leadership group, the HPTN LC will help shape the network’s scientific agenda. The HPTN LC will oversee laboratory activities at study sites; perform Quality Assurance/Quality Control (QA/QC) and specialized testing for HPTN protocols; evaluate and validate assays for use in HPTN studies; develop novel assays to achieve study objectives; and perform ancillary studies related to HIV prevention. The HPTN LC has an Administrative Core, a Protocol Operations Core, and five laboratory Cores (Virology, Pharmacology, Co-Infections, Toxicology, Immunology). The HPTN LC also has an Early Product Development Working Group and a working group for Point-of-Care Testing and Remote Technologies. The HPTN LC has extensive experience supporting HIV protocols in the United States (US), Latin America, Africa, and Asia, with recent work in Eastern Europe. The HPTN LC includes seven Protocol Specialists with >100 combined years of experience supporting HPTN studies. The HPTN LC has led efforts to harmonize laboratory procedures across other networks and groups, and collaborates extensively with academic, government, and industry partners. The HPTN LC has supported protocols evaluating biomedical, behavioral, and structural interventions for HIV prevention, often delivered in combination in a wide range of settings and venues. This includes vanguard studies, observational studies, and Phase 1, 2, and 3 clinical trials, with interventions delivered to HIV-uninfected individuals, HIV-infected individuals, couples, cohorts, and communities. HPTN study populations include adolescents, women, men who have sex with men, transgender women, persons who inject drugs, and other groups at risk, with some trials enrolling >40,000 participants. The HPTN LC has performed numerous studies under Investigational New Drug (IND) applications for the US Food and Drug Administration. The HPTN LC’s Quality Management Team includes a Regulatory Affairs Officer who will ensure compliance with institutional, state, federal, and other regulatory requirements. Under the new award, the HPTN will evaluate new products for HIV pre-exposure prophylaxis, including new drugs, new drug delivery systems, multipurpose technologies, and broadly neutralizing antibodies; the HPTN will also perform integrated strategy studies that combine biomedical and socio-behavioral interventions for HIV prevention. The Specific Aims of the HPTN LC are: Aim 1: To provide leadership, expertise, and laboratory support to the HPTN; Aim 2: To support site laboratories and ensure the quality of HPTN laboratory results; and Aim 3: To advance HIV prevention science through assay development and biomedical research. A strong and effective HPTN LC is particularly important in the HPTN because of the vast international scope, diversity, and complexity of HIV prevention trials. This award will enable the HPTN to continue its mission to identify effective strategies for HIV prevention that will help end the HIV/AIDS epidemic.