UCSD Collaborative Clinical Trials Unit

摘要 加州大学圣地亚哥分校合作临床试验单位（CTU）将汇集七个动态的美国和国际 临床研究中心（CRS），以促进创新的科学协同作用和利用研究合作 在我们CTU的调查人员中，贡献我们的科学专长和我们多样化的参与者， 艾滋病毒/艾滋病成人治疗药物临床试验的研究重点 网络和艾滋病毒预防临床试验网络。我们的七种CRS包括：1）UCSD Antiviral 研究中心（AVRC）CRS; 2）南加州大学（USC）CRS; 3） 科罗拉多医院（UCH）CRS; 4）休斯顿艾滋病研究小组（哈特）CRS; 5） 迈阿密CRS; 6）钦奈抗病毒研究和治疗（CART）CRS，以及; 7）德班 国际（DI）CRS。每一个都将带来相当的实力，以实现未来两个研究目标， 四个NIAID网络我们的合作CTU汇集了丰富的专业知识，经验和高 在以下领域进行复杂的临床试验所需的质量性能：HIV治愈和功能 治愈;病毒持久性和潜在的水库;广泛中和抗体的治疗方法， 预防HIV; HIV相关炎症、合并感染和合并症的发病机制和治疗; 治疗和预防艾滋病毒的新抗逆转录病毒药物和新制剂; 结核病（TB）的人与单一和艾滋病毒合并感染;和生物医学，社会行为， 预防艾滋病毒传播的多用途技术战略（包括暴露前预防[PrEP]， 艾滋病毒预防性疫苗和分子流行病学以“热点”为目标） 传输我们的CTU提供访问和长期的经验，与社区参与， 代表性不足的西班牙裔/拉丁裔、黑人/非裔美国人、非洲人和南亚人群， 感染艾滋病毒及其并发症。我们的美国CRS跨越了几个慢性病负担最高的地区， 在东南部（迈阿密）、南部（休斯顿）、西南部（丹佛）和边境地区（洛杉矶）， 洛杉矶，圣地亚哥）在美国“结束艾滋病毒流行计划”运动中确定。我们的国际CRS 包括全球艾滋病毒和结核病负担最重的两个地区，特别是耐药结核病（南方 印度和南非）。我们将致力于实现以下具体目标。具体目标1：提供杰出的， 对艾滋病毒/艾滋病成人治疗药物临床试验网络的创新科学贡献和领导 艾滋病预防临床试验网络具体目标2：提供有效和高效的 行政和财政资源管理。具体目标3：与各种不同的 受艾滋病毒影响的社区，以形成网络科学议程，并招募，登记和保留广泛的 网络研究中研究试验参与者的多样性。

Abstract The UCSD Collaborative Clinical Trials Unit (CTU) will bring together seven dynamic U.S. and International Clinical Research Sites (CRSs) to facilitate innovative scientific synergies and leverage research collaborations among investigators across our CTU and to contribute our scientific expertise and our diverse participant populations to further the research priorities of the NIAID HIV/AIDS Adult Therapeutics Clinical Trials Network and the HIV Prevention Clinical Trials Network. Our seven CRSs include: 1) the UCSD Antiviral Research Center (AVRC) CRS; 2) the University of Southern California (USC) CRS; 3) the University of Colorado Hospital (UCH) CRS; 4) the Houston AIDS Research Team (HART) CRS; 5) the University of Miami CRS; 6) the Chennai Antiviral Research and Treatment (CART) CRS, and; 7) the Durban International (DI) CRS. Each will bring considerable strength to achieve the future research goals of two of the four NIAID networks. Our Collaborative CTU brings together a wealth of expertise, experience, and the high quality performance required to conduct complex clinical trials in the following areas: HIV cure and functional cure; viral persistence and latent reservoirs; broadly neutralizing antibody approaches to treatment and prevention of HIV; pathogenesis and treatment of HIV-related inflammation, coinfections and comorbidities; new antiretroviral drugs and novel formulations for HIV treatment and prevention; treatment and prevention of tuberculosis (TB) in persons with mono- and HIV-coinfection; and biomedical, socio-behavioral, and multipurpose technology strategies to prevent HIV transmission (including pre-exposure prophylaxis [PrEP], HIV preventive vaccines, and molecular epidemiology to target “hot spots”) in populations at high risk for HIV transmission. Our CTU provides access to and long-standing experience with community engagement in underrepresented Hispanic/Latinx, Black/African American, African, and South Asian populations at risk for or affected by HIV and its complications. Our U.S. CRSs span several of the highest burden regions for chronic and new HIV infections in the southeast (Miami), south (Houston), southwest (Denver) and border regions (Los Angeles, San Diego) identified in the U.S. “Plan to End the HIV Epidemic” campaign. Our international CRSs include two of the highest burden regions globally for both HIV and TB, particularly drug-resistant TB (Southern India and South Africa). We will address the following specific aims. Specific Aim 1: To provide outstanding, innovative scientific contributions and leadership to the HIV/AIDS Adult Therapeutics Clinical Trials Network and the HIV Prevention Clinical Trials Network. Specific Aim 2: To provide effective and efficient administrative and financial resource management. Specific Aim 3: To engage and partner with diverse communities affected by HIV to shape network scientific agendas and to recruit, enroll and retain a broad diversity of research trial participants in network studies.