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.

抽象的 UCSD合作临床试验部（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作用并利用研究合作 在我们CTU的调查人员中 人群进一步研究NIAID HIV/AIDS成人治疗临床试验的研究优先级 网络和HIV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）大学 科罗拉多州医院（UCH）CRS； 4）休斯顿艾滋病研究团队（HART）CRS； 5）大学 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。每个人都将带来考虑力量，以实现两个的未来研究目标 四个NIAID网络。我们的合作CTU汇集了丰富的专业知识，经验和高昂的 在以下领域进行复杂的临床试验所需的质量性能：HIV治疗和功能 治愈;病毒持久性和潜在水库；广泛中和抗体的治疗方法 预防艾滋病毒； HIV相关炎症，共同感染和合并症的发病机理和治疗； 用于HIV治疗和预防的新型抗逆转录病毒药物和新型公式；治疗和预防 有单和艾滋病毒感染的人的结核病（TB）；和生物医学，社会行为和 多功能技术策略以防止HIV传播（包括预防前预防[PREP]， 艾滋病毒的艾滋病毒预防疫苗和分子流行病学，以hiv风险高的人群中的“热点”） 传播。我们的CTU为社区参与提供了访问和长期的经验 代表不足的西班牙裔/拉丁裔，黑人/非洲裔美国人，非洲和南亚人口有风险或 受艾滋病毒及其并发症的影响。我们的美国CRS跨越了慢性的几个最高燃烧区域 东南部（迈阿密），南部（休斯顿），西南（丹佛）和边境地区的新艾滋病毒感染（Los） 圣地亚哥的安吉尔斯）在美国确定的“计划结束艾滋病毒流行”运动。我们的国际CRS 包括艾滋病毒和结核病全球最高的烧伤区域之一，尤其是耐药结核病（南部 印度和南非）。我们将解决以下特定目标。特定目标1：提供杰出的目的， 艾滋病毒/艾滋病的创新科学贡献和领导成人临床试验网络 和HIV预防临床试验网络。特定目的2：提供有效和高效 行政和财务资源管理。特定目标3：与潜水员互动并合作 受艾滋病毒影响塑造网络科学议程并招募，注册和保留广泛的社区 网络研究中的研究试验参与者的多样性。