The UCSD CD4 Collaborative Clinical Trial Unit

UCSD CD4 合作临床试验单位

基本信息

批准号：
8784154
负责人：
CONSTANCE ANN BENSON
金额：
$ 10.33万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN DIEGO
依托单位国家：
美国
项目类别：
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/8784154
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 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 Productivity Prophylactic treatment Protocols documentation Recruitment Activity Research Research Infrastructure Research Personnel Research Priority Resources Science Shapes Site South Africa South Asian Sum Therapeutic Therapeutic Clinical Trial Therapeutic Intervention Tuberculosis Universities Vaccines Viral Viral Vaccines Viral hepatitis Work adolescent patient base clinical research site co-infection drug development experience flexibility high risk improved innovation medical schools novel patient population pediatric patients prevent programs response transmission process vaccine development

项目摘要

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 CD4协作临床试验单元（CTU）将汇集六个动态和多样化的临床研究地点（CRS），他们准备充分地响应NIAID HIV/AIDS临床研究网络的研究优先级。我们的CTU汇集了在艾滋病毒治疗，旨在治愈，功能治愈和消除HIV的HIV治疗干预措施的成年人，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业知识和经验；新的和新颖的抗逆转录病毒药物开发；与HIV相关的共感染和合并症，包括机会性感染和其他最终器官疾病；在HIV共感染和结核病的个体中治疗和预防结核病（TB）；在共感染和单感染的个体中治疗和治愈病毒肝炎；包括孕妇在内的高风险人群中，生物医学和行为干预措施以减少或预防艾滋病毒传播（包括暴露前预防，预防后预防和预防疫苗预防策略）；在艾滋病毒疾病的发病机理中，包括病毒持久性，潜在储层，病毒和疫苗免疫学以及疫苗发育。通过我们的CD4协作CTU，我们将解决以下具体目的（在此处简要概述）：特定目标1（创新的科学基础架构）：提供科学专业知识，高效，灵活的基础架构，以开发新的策略，以改善以下NIAID临床研究网络的预防和治疗，以提高艾滋病毒感染，以下是NIAID临床研究网络，以下是HEID ISAPIS and a），并且HIV IADICT和HIV IVINT IVINT和HIV in IVINT和HIV in IVINT和HIV in IVISTIST和HIV in IV in IV in IV和HIV; b）小儿和母体种群中的艾滋病毒/艾滋病和艾滋病毒相关感染； c）预防艾滋病毒感染的综合策略； D）预防HIV感染的疫苗。具体目标2（有效的科学领导力）：在CTU内，CRS，CTU服务的社区以及我们CTU参与的临床研究网络中，在CTU内，CRSS，CRSS内，在CTU中提供出色，有效的领导力。特定目标3（有效的财政管理和绩效）：有效地管理所有财务和基础设施资源，并监督，评估和确保所有组件的示例性能。特定目标4（社区参与）：与受影响的社区互动并合作，以塑造网络科学议程并招募，入学和保留网络研究的理想研究试验参与者。相关性：UCSD CD4协作临床试验单元（CTU）汇集了美国，撒哈拉以南非洲和印度的六个动态临床研究地点，并具有对艾滋病毒发病机理和治疗的重大研究的可靠记录。我们提出的CTU具有专业知识，经验，基础设施，并获得了种族和种族多元化的成人，青少年和儿科患者人群，以对NIAID临床研究网络的研究优先事项做出宝贵的贡献。