Chicago Clinical Trials Unit

项目摘要。芝加哥临床试验单位（CCTU）是一个由四个临床研究中心组成的联盟 （CRS）将解决NIAID的两个优先临床研究领域：1）成人艾滋病毒/艾滋病治疗 策略，包括新疗法、HIV治愈、非感染性合并症和感染性合并症 B型肝炎和结核病; 2）综合艾滋病毒预防战略，包括新型长效抗逆转录病毒药物， 基于艾滋病毒的预防剂和暴露前预防（PrEP）的输送系统，多用途 预防技术，综合生物医学和社会行为艾滋病毒预防战略， 与艾滋病毒疫苗网络的合作协议测试抗体介导的预防战略。的 CCTU由四个经验丰富，科学生产力的CRS组成，它们具有独特的定位， 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。的 CCTU拥有良好的往绩记录，并将通过积极参与多元化的 许多高危和受艾滋病毒影响的社区，参与影响力大、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。遵守所有相关规则和条例是 财团中央反恐组包括社区服务中心和长期参与反恐工作的人员。 两个研究网络与中央反恐局是附属的，和平台的网络间合作， 其他的NIAID网络CRS及其网络附属机构是：西北大学（成人） 艾滋病毒/艾滋病治疗策略）;拉什大学（成人艾滋病毒/艾滋病治疗策略）; Trinity Health & 健康中心（成人艾滋病毒/艾滋病治疗战略）;和露丝L。罗斯坦核心中心（艾滋病毒 预防和成人艾滋病毒/艾滋病治疗战略）。在芝加哥和达拉斯， 位于库克县和达拉斯县，这是48个“热点”县中的两个县， 美国的确诊病例集中在2016年和2017年。该提案的目标是：发展， 实施和调整1）成人艾滋病毒/艾滋病治疗的临床研究方案 在四个社区服务中心建立临床试验网络，2）在一个社区服务中心建立艾滋病毒预防网络，与 3）确保所有CCTU的研究与受艾滋病毒影响的人群相关， 通过社区在研究的各个阶段的动态参与来实现道德。中央反恐组是 有能力接触不同的人群，并为NIAID研究议程做出重大贡献。 相关性：过去35年来，艾滋病毒/艾滋病研究取得了惊人的科学进步， 在很大程度上是由于NIAID的高影响力的治疗和预防研究正在进行的临床 试验单位（CTU）。CCTU将继续快速响应新兴的临床研究需求， 我们的目标是，制定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.