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）：UCSD CD 4合作临床试验单位（CTU）将汇集六个充满活力和多样化的临床研究地点（CRS），这些地点已做好充分准备，以应对NIAID HIV/AIDS临床研究网络的研究重点。我们的技术股汇集了在成人、青少年、儿童和孕妇中进行各种复杂的临床试验所需的科学专门知识和经验，这些试验涉及艾滋病毒治疗干预措施，旨在治愈、功能治愈和根除艾滋病毒;新型抗逆转录病毒药物的开发;与艾滋病毒有关的合并感染和合并症，包括机会性感染和其他终末器官疾病;治疗和预防艾滋病毒合并感染者和结核病单一感染者的结核病（TB）;治疗和治愈合并感染者和结核病单一感染者的病毒性肝炎;减少或预防艾滋病毒传播的生物医学和行为干预措施（包括接触前预防、接触后预防和疫苗预防战略）;以及HIV疾病的发病机制，包括病毒持久性、潜伏性储库、病毒和疫苗免疫学以及疫苗开发。通过我们的CD 4合作CTU，我们将实现以下具体目标（简要概述）：具体目标1（创新科学基础设施）：提供科学专门知识和有效、灵活的基础设施，以制定新的战略，在以下NIAID临床研究网络范围内改善艾滋病毒感染的预防和治疗：B）儿童和产妇中的艾滋病毒/艾滋病和与艾滋病毒有关的感染; 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、整个CRS、CTU服务的社区以及我们CTU将参与的临床研究网络中，提供出色、有效的行政协调和科学参与领导。具体目标3（有效的财务管理和绩效）：有效管理所有财务和基础设施资源，并监督、评估和确保所有组成部分的模范绩效。具体目标4（社区参与）：与受影响的社区进行合作，以制定网络科学议程，并在网络研究中招募、登记和留住理想的研究试验参与者。 相关性：UCSD CD 4合作临床试验单位（CTU）汇集了美国六个动态临床研究中心，在撒哈拉以南非洲和印度，对艾滋病毒及其并发症的发病机理和治疗进行了大量研究，这方面的记录已得到证实。我们提议的CTU拥有专业知识，经验，基础设施，并能够接触到种族和民族多样化的成人，青少年和儿科患者人群，为NIAID临床研究网络的研究重点做出宝贵贡献。