The UCSD CD4 Collaborative Clinical Trial Unit

UCSD CD4 合作临床试验单位

• 批准号: 9179576
• 负责人: CONSTANCE ANN BENSON
• 金额: $ 237万
• 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 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9179576
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Administrative Coordination; Adolescent; Adult; Affect; Africa South of the Sahara; African; African American; Anti-Retroviral Agents; Antiviral Agents; Area; Behavior Therapy; California; Child; Childhood; Clinical Research; Clinical Treatment; Clinical Trials; Clinical Trials Unit; Collaborations; Colorado; Communication; Communities; Community Networks; Comorbidity; Complex; Disease; Education; Education and Outreach; Enrollment; Evaluation; Focus Groups; Fostering; Future; Geographic Distribution; Geographic Locations; HIV; HIV Infections; Hispanics; Hospitals; Immunologic Deficiency Syndromes; Immunology; India; Individual; Infection; International; Latino; Leadership; Mentors; Mono-S; National Institute of Allergy and Infectious Disease; Opportunistic Infections; Organ; Participant; Pathogenesis; Pediatric Hospitals; Performance; Persons; Population; Populations at Risk; Pregnant Women; Prevention; Prevention strategy; Preventive vaccine; Productivity; Prophylactic treatment; Protocols documentation; Recruitment Activity; Research; Research Infrastructure; Research Personnel; Research Priority; Resources; Science; Shapes; Site; South Africa; South Asian; Sum; Talents; Therapeutic; Therapeutic Clinical Trial; Therapeutic Intervention; Tuberculosis; Universities; Vaccines; Viral; Viral Vaccines; Viral hepatitis; adolescent patient; base; clinical research site; co-infection; drug development; ethnic diversity; experience; flexibility; high risk population; improved; innovation; medical schools; novel; patient population; pediatric patients; pre-exposure prophylaxis; prevent; programs; racial diversity; response; synergism; transmission process; vaccine development

DESCRIPTION (provided by the applicant): The UCSD CD4 Collaborative Clinical Trials Unit (CTU) will bring together six dynamic and diverse Clinical Research Sites (CRSs) that are well prepared to respond to the research priorities of the NIAID HIV/AIDS clinical research networks. Our CTU brings together the scientific expertise and experience required to conduct a broad variety of complex clinical trials in adults, adolescents, children and pregnant women in the areas of HIV therapeutic interventions aimed at cure, functional cure and eradication of HIV; new and novel antiretroviral drug development; HIV-related co-infections and comorbidities, including opportunistic infections and other end organ diseases; treatment and prevention of tuberculosis (TB) in HIV co-infected and TB mono-infected individuals; treatment and cure of viral hepatitis in co-infected and mono-infected individuals; biomedical and behavioral interventions to reduce or prevent HIV transmission (including pre-exposure prophylaxis, post-exposure prophylaxis and vaccine prevention strategies) in high risk populations, including pregnant women; and in the pathogenesis of HIV disease, including viral persistence, latent reservoirs, viral and vaccine immunology, and vaccine development. Through our CD4 Collaborative CTU we will address the following specific aims (briefly summarized here): Specific Aim 1 (Innovative Science Infrastructure): Provide scientific expertise and efficient, flexible infrastructure to develop new strategies to improve the prevention and treatment of HIV infection within the context of the following NIAID Clinical Research Networks on: a) Therapeutics for HIV/AIDS and HIV associated Infections in Adults; b) HIV/AIDS and HIV-associated Infections in Pediatric and Maternal Populations; c) Integrated Strategies to Prevent HIV Infection; d) Vaccines to Prevent HIV Infection. Specific Aim 2 (Effective Scientific Leadership): Provide excellent, effective leadership in administrative coordination and scientific participation within the CTU, across the CRSs, within communities served by the CTU, and across the clinical research networks in which our CTU will participate. Specific Aim 3 (Effective Fiscal Management and Performance): Effectively manage all financial and infrastructure resources, and oversee, evaluate and assure exemplary performance of all components. Specific Aim 4 (Community Engagement): Engage and partner with affected communities to shape network scientific agendas and to recruit, enroll and retain ideal research trial participant in network studies. RELEVANCE: The UCSD CD4 Collaborative Clinical Trials Unit (CTU) brings together six dynamic Clinical Research Sites in the U.S., sub-Saharan Africa, and India, with a proven track record of significant research into the pathogenesis and treatment of HIV and its complications. Our proposed CTU has the expertise, experience, infrastructure, and access to racially and ethnically diverse adult, adolescent and pediatric patient populations to make valuable contributions to the research priorities of the NIAID clinical research networks.

描述(由申请人提供)：加州大学圣迭戈分校的CD4合作临床试验单位(CTU)将汇集六个动态和多样化的临床研究网站(CRSS)，这些网站已经做好充分准备，以响应NIAID艾滋病毒/艾滋病临床研究网络的研究优先事项。我们的CTU汇集了在成人、青少年、儿童和孕妇中进行各种复杂临床试验所需的科学专门知识和经验，这些领域包括：旨在治愈、功能治愈和根除艾滋病毒的艾滋病毒治疗干预措施；新型和新的抗逆转录病毒药物开发；艾滋病毒相关的混合感染和共病，包括机会性感染和其他终端器官疾病；治疗和预防艾滋病毒联合感染和结核病单一感染者的结核病；治疗和治愈联合感染者和单一感染者的病毒性肝炎；减少或预防艾滋病毒在包括孕妇在内的高危人群中传播的生物医学和行为干预措施(包括暴露前预防、暴露后预防和疫苗预防战略)；以及艾滋病毒疾病的发病机制，包括病毒持久性、潜伏宿主、病毒和疫苗免疫学以及疫苗开发。通过我们的CD4合作CTU，我们将实现以下具体目标(在此简要概述)：具体目标1(创新的科学基础设施)：提供科学专业知识和高效、灵活的基础设施，在以下NIAID临床研究网络的背景下制定新的战略，以改进艾滋病毒感染的预防和治疗：a)成人艾滋病毒/艾滋病和艾滋病毒相关感染的治疗；b)儿科和孕产妇人口中的艾滋病毒/艾滋病和艾滋病毒相关感染；c)预防艾滋病毒感染的综合战略；d)预防艾滋病毒感染的疫苗。具体目标2(有效的科学领导)：在CTU内部、CRSS、CTU服务的社区以及我们CTU将参与的临床研究网络中，在行政协调和科学参与方面提供出色、有效的领导。具体目标3(有效的财政管理和业绩)：有效管理所有财政和基础设施资源，监督、评价和确保所有组成部分的模范业绩。具体目标4(社区参与)：让受影响的社区参与并与之合作，以形成网络科学议程，并招募、招募和留住网络研究中理想的研究试验参与者。 相关性：UCSD CD4协作临床试验中心(CTU)汇集了美国、撒哈拉以南非洲和印度的六个活跃的临床研究站点，在艾滋病毒及其并发症的发病机制和治疗方面拥有公认的重要研究记录。我们建议的CTU拥有专业知识、经验、基础设施，并能够接触到不同种族和民族的成人、青少年和儿科患者群体，为NIAID临床研究网络的研究重点做出宝贵贡献。