Chicago Clinical Trials Unit

项目摘要。芝加哥临床试验单位(CCTU)是由四个临床研究站点组成的联盟 (CRSS)将涉及NIAID的两个优先临床研究领域：1)成人艾滋病毒/艾滋病治疗 战略，包括新的治疗方法、艾滋病毒治疗、非传染性并存和传染性并存 2)综合艾滋病毒预防战略，包括新的长效抗逆转录病毒病毒-- 多用途暴露前预防(PrEP)的艾滋病毒防治剂和递送系统 预防技术、综合生物医学和社会行为艾滋病毒预防战略；以及 与艾滋病毒疫苗网络合作测试抗体介导的预防策略。这个 CCTU由四个经验丰富、科学成果丰富的CRSS组成，它们的独特定位是 制定、实施和调整NIAID临床研究优先领域的临床研究优先事项。这个 CCTU有经过验证的记录，并将通过与不同的 高风险和受艾滋病毒影响的社区的主机，参与高影响、突破性的临床研究 研究、资源的有效管理和临床活动的关键绩效监督， 实验室和药房。遵守所有相关规章制度是该委员会的优先事项 财团。CCTU包括CRSS和与CCTU有长期生产性参与的人员 CCTU所属的两个研究网络，以及网络间协作的平台 其他的NIAID网络。CRSS及其网络附属机构为：西北大学(成人 艾滋病毒/艾滋病治疗战略)；拉什大学(成人艾滋病毒/艾滋病治疗战略)；三一健康与 健康中心(成人艾滋病毒/艾滋病治疗战略)；Ruth L.Rothstein核心中心(艾滋病毒 预防和成人艾滋病毒/艾滋病治疗战略)。芝加哥和达拉斯这两个城市，CRSS 都位于库克县和达拉斯县，这两个县是48个热点县中的两个，那里有一半的新艾滋病毒 美国的诊断集中在2016年和2017年。这项建议的目的是：发展， 成人HIV/AIDS治疗学临床研究计划的实施与适应 战略四个CRS的临床试验网络，以及2)一个CRS的艾滋病毒预防网络，与 CCTU的所有要素，以及3)确保CCTU的所有研究都与受艾滋病毒影响的人群相关，以及 通过社区在研究的所有阶段的动态参与来实现道德。CCTU是 处于有利地位，能够接触到不同的人群，并为NIAID的研究议程做出重大贡献。 相关性：在过去的35年里，艾滋病毒/艾滋病研究取得了惊人的科学进步 很大程度上是由于NIAID的临床研究正在进行高影响力的治疗和预防研究 试验单位(CTU)。CCTU将继续对新的临床研究需求做出快速反应，参与 并找出更有效的治疗和预防策略。

Project Summary. The Chicago Clinical Trials Unit (CCTU) is a consortium of four Clinical Research Sites (CRSs) which will address two priority clinical research areas of the NIAID: 1) adult HIV/AIDS therapeutic strategies, including novel therapeutics, HIV cure, noninfectious comorbidities, and infectious comorbidities of hepatitis B and tuberculosis; and 2) integrated HIV prevention strategies, including novel long-acting ARV- based HIV prevention agents and delivery systems for Pre-exposure Prophylaxis (PrEP), multi-purpose prevention technologies, integrated biomedical and socio-behavioral HIV prevention strategies, and collaborative protocols with the HIV Vaccines Network testing antibody-mediated prevention strategies. The CCTU consists of four highly experienced and scientifically productive CRSs that are uniquely positioned to develop, implement and adapt the clinical research priorities of the NIAID clinical research priority areas. The CCTU has a proven track record and will continue its productivity through active engagement with a diverse host of at-risk and HIV-impacted communities, participation in high impact, ground-breaking clinical research studies, efficient management of resources and critical performance oversight of the clinical activities, laboratories, and pharmacies. Compliance with all relevant rules and regulations is a priority of the consortium. The CCTU includes CRSs and personnel that have long-term productive involvement with the two research networks with which the CCTU is affiliated, and platforms for inter-network collaboration with the other NIAID networks. The CRSs and their network affiliations are: Northwestern University (adult HIV/AIDS therapeutic strategies); Rush University (adult HIV/AIDS therapeutic strategies); Trinity Health & Wellness Center (adult HIV/AIDS therapeutic strategies); and The Ruth L. Rothstein CORE Center (HIV prevention and adult HIV/AIDS therapeutic strategies). The cities of Chicago and Dallas, where the CRSs are located, are in Cook and Dallas counties, two of the 48 “hot spots” counties where half of new HIV diagnoses in the US were concentrated in 2016 and 2017. The aims of this proposal are: development, implementation and adaptation of the clinical research program of the 1) Adult HIV/AIDS Therapeutics Strategies Clinical Trials Network in four CRSs, and 2) HIV Prevention Network in one CRS, in synergy with all CCTU elements, and 3) To ensure all CCTU research is relevant to HIV impacted populations and ethical through dynamic engagement of the community in all phases of the research. The CCTU is well-positioned to reach diverse populations and contribute significantly to the NIAID research agenda. RELEVANCE: The phenomenal scientific advances in HIV/AIDS research over the past 35 years have in large part been due to NIAID's high-impact therapeutic and prevention studies being performed by its clinical trials units (CTUs). The CCTU will continue to respond rapidly to emerging clinical research needs, engage constituents, and identify more effective treatment and prevention strategies.