UCSD Collaborative Clinical Trials Unit

加州大学圣地亚哥分校合作临床试验单位

• 批准号: 10304895
• 负责人: CONSTANCE ANN BENSON
• 金额: $ 362.34万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-01 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10304895
• 关键词: AIDS prevention; AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Adult; Affect; Africa South of the Sahara; African; African American; Anti-Retroviral Agents; Area; Black race; California; Chronic; Clinical Treatment; Clinical Trials; Clinical Trials Design; Clinical Trials Network; Clinical Trials Unit; Collaborations; Colorado; Communication; Communities; Community Networks; Complex; Disease; Drug Formulations; Drug resistance in tuberculosis; Education and Outreach; Enrollment; Epidemic; Evaluation; Formulation; Geographic Distribution; Geographic Locations; Geography; Goals; HIV; HIV Infections; HIV/TB; Hepatitis B; Hispanic; Hospitals; Hot Spot; India; Inflammation; Infrastructure; International; Latinx; Leadership; Los Angeles; Mentors; Metabolic; Molecular Epidemiology; National Institute of Allergy and Infectious Disease; Organ; Participant; Pathogenesis; Performance; Persons; Pharmaceutical Preparations; Population; Populations at Risk; Prevention; Preventive vaccine; Productivity; Research; Research Infrastructure; Research Personnel; Research Priority; Resources; Risk; Shapes; Social Behavior; South Africa; South Asian; Sum; Talents; Technology; Therapeutic Clinical Trial; Tuberculosis; Universities; Viral; clinical center; clinical research site; co-infection; community based participatory research; community engagement; comorbidity; ethnic diversity; experience; high risk; innovation; neutralizing antibody; novel; pre-exposure prophylaxis; prevent; racial diversity; recruit; synergism; transmission process; working group

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.

摘要 UCSD协作临床试验单位(CTU)将汇集七个充满活力的美国和国际 临床研究网站(CRSS)，以促进创新的科学协同效应和利用研究合作 在整个CTU的调查人员中，并贡献我们的科学专业知识和我们多样化的参与者 NIAID艾滋病毒/艾滋病成人治疗临床试验的研究重点 网络和艾滋病毒预防临床试验网络。我们的七个CRS包括：1)UCSD抗病毒 研究中心(AVRC)CRS；2)南加州大学(USC)CRS；3) 科罗拉多医院(UCH)CRS；4)休斯顿艾滋病研究团队(HART)CRS；5)休斯顿大学 迈阿密CRS；6)金奈抗病毒研究和治疗(CART)CRS；7)德班 国际(DI)CRS。每一项都将带来相当大的力量，以实现其中两项未来的研究目标 四个NIAID网络。我们的协作CTU汇集了丰富的专业知识、经验和 在以下领域进行复杂临床试验所需的质量表现：艾滋病毒治愈和功能 治愈；病毒持久性和潜伏期；广泛中和抗体治疗方法和 预防艾滋病毒；艾滋病毒相关炎症、共感染和共病的发病机制和治疗； 用于艾滋病毒治疗和预防的新的抗逆转录病毒药物和新配方；治疗和预防 单一感染者和艾滋病毒混合感染者中的结核病；生物医学、社会行为和 预防艾滋病毒传播的多用途技术战略(包括暴露前预防[PrEP]， 艾滋病毒预防疫苗，以及针对艾滋病毒高危人群的分子流行病学) 变速箱。我们的CTU提供了社区参与的途径和长期的经验 未被充分代表的西班牙裔/拉丁裔、黑人/非裔美国人、非洲人和南亚人面临或 受艾滋病毒及其并发症的影响。我们的美国CRSS覆盖了几个慢性病负担最重的地区 东南部(迈阿密)、南部(休斯顿)、西南部(丹佛)和边境地区(洛杉矶)出现新的艾滋病毒感染病例 洛杉矶、圣地亚哥)在美国“结束艾滋病毒流行的计划”运动。我们的国际CRSS 包括全球艾滋病毒和结核病负担最高的两个地区，特别是耐药结核病(南部 印度和南非)。我们将解决以下具体目标。具体目标1：提供杰出的、 对艾滋病毒/艾滋病成人治疗临床试验网络的创新科学贡献和领导 和艾滋病毒预防临床试验网络。具体目标2：提供有效和高效的 行政和财务资源管理。具体目标3：与不同的企业建立合作伙伴关系 受艾滋病毒影响的社区形成网络科学议程，并招募、招收和保留广泛的 网络研究中研究试验参与者的多样性。