Vanderbilt HIV Clinical Trials Unit (CTU)

项目摘要/摘要 艾滋病毒大流行是对健康和发展的最大持续威胁之一，在过去35年里 承认。NIAID资助的临床试验网络在协调应对 艾滋病毒/艾滋病领域的关键研究问题，这将有助于最终结束艾滋病毒流行。这个 范德比尔特艾滋病毒临床试验单位(CTU)将继续与范德比尔特大学之间建立的合作伙伴关系 田纳西州纳什维尔的医疗中心和密苏里州圣路易斯市的华盛顿大学，它们位于 美国艾滋病毒发病率和流行率较高的地区。CTU由三个高度 为三个网络做出贡献的生产性临床研究网站(CRSS)--美国医学会的治疗使命 艾滋病临床试验小组(ACTG)，艾滋病毒疫苗试验网络(HVTN)的疫苗任务，以及非 艾滋病毒预防试验网络(HPTN)的疫苗预防任务。范德比尔特疫苗CRS和 华盛顿大学治疗公司CRS自成立以来一直是HVTN和ACTG的成员 这些网络在1987-1988年间。Vanderbilt Treateutics CRS于2000年加入ACTG。做出更多贡献 广泛地说到网络，华盛顿大学已经为HPTN提供了特定于协议的注册 2016年，并提议成为HPTN的正式成员网站，作为华盛顿大学预防和 治疗公司CRS。这个CTU的领导人在科学和方案上对 包括人类基因组学、当代艾滋病毒相关共病、神经学等领域的网络 艾滋病毒疾病、疫苗反应的免疫学等方面。在拟议的资助期内， 范德比尔特CTU将继续为ACTG、HVTN和HPTN的科学研究做出实质性贡献 优先事项。范德比尔特和华盛顿大学的ACTG网站将专注于改善健康的战略 患有艾滋病毒/艾滋病、结核病和病毒性肝炎的人。范德比尔特HVTN网站将对这两个方面做出贡献 研究参与者和前沿免疫学技术，以进一步发展的重大科学优先事项 以及测试一种安全有效的艾滋病毒疫苗。华盛顿大学的网站还将有助于 HPTN强调暴露前预防的长效剂，开发多用途技术 如将艾滋病毒预防与避孕相结合，以及将生物医学、行为学和 预防的结构性干预措施。CTU的所有CRS都有成功招生的既定记录 参与者以最高的忠诚度进行临床试验和研究，以确保参与者的安全和质量 促进艾滋病毒治疗和预防科学的数据。

PROJECT SUMMARY/ABSTRACT The HIV pandemic is one of the greatest ongoing threats to health and development, over 35 years past its recognition. The NIAID-funded Clinical Trials Networks have played critical roles in the coordinated response to key research questions in the HIV/AIDS field, which will contribute to ultimately ending the HIV epidemic. The Vanderbilt HIV Clinical Trials Unit (CTU) will continue the established partnership between Vanderbilt University Medical Center in Nashville, Tennessee, and Washington University in St. Louis, Missouri, which are located in a region of the United States with high incidence and prevalence of HIV. This CTU comprises three highly productive Clinical Research Sites (CRSs) that contribute to three Networks - the therapeutics mission of the AIDS Clinical Trials Group (ACTG), the vaccine mission of the HIV Vaccine Trials Network (HVTN), and the non- vaccine prevention mission of the HIV Prevention Trials Network (HPTN). The Vanderbilt Vaccine CRS and Washington University Therapeutics CRS have been members of the HVTN and ACTG since the inception of these Networks in 1987-1988. The Vanderbilt Therapeutics CRS joined the ACTG in 2000. To contribute more broadly to the Networks, Washington University has provided protocol-specific enrollment to the HPTN since 2016, and proposes to become a full member site of the HPTN, as the Washington University Prevention & Therapeutics CRS. Leaders of this CTU have made high-impact scientific and programmatic contributions to the Networks in areas that include human genomics, contemporary HIV-associated comorbidities, neurological aspects of HIV disease, immunology of vaccine response, and beyond. During the proposed funding period, the Vanderbilt CTU will continue to make substantial contributions to the ACTG, HVTN and HPTN's scientific priorities. ACTG sites at both Vanderbilt and Washington University will focus on strategies to improve the health of people living with HIV/AIDS, tuberculosis, and viral hepatitis. The Vanderbilt HVTN site will contribute both study participants and cutting-edge immunologic technologies to further the major scientific priority of developing and testing a safe and effective vaccine for HIV. The Washington University site will additionally contribute to HPTN's emphasis on long-acting agents for pre-exposure prophylaxis, developing multipurpose technologies such as combining HIV prevention with contraception, and strategies integrating biomedical, behavioral and structural interventions for prevention. All CRSs of this CTU have an established record of success in enrolling participants to clinical trials and conducting studies with utmost fidelity to ensure participant safety and quality data advancing the science of HIV treatment and prevention.