UCSD Department of Medicine HIV/AIDS Clinical Trials Unit

加州大学圣地亚哥分校医学系艾滋病毒/艾滋病临床试验组

• 批准号: 7994193
• 负责人: CONSTANCE ANN BENSON
• 金额: $ 464.62万
• 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 2013-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7994193
• 关键词: AIDS clinical trial group; AIDS/HIV problem; Acute; Adolescent; Anti-Retroviral Agents; Antiviral Agents; Area; Behavior Therapy; California; Chronic; Clinical Management; Clinical Trials; Clinical Trials Unit; Collaborations; Complement; Conduct Clinical Trials; County; Disease; Drug resistance; Elderly; Evaluation; Grant; HIV; HIV prevention trials network; HIV-1; Immunotherapeutic agent; Individual; Infection; Leadership; Medical center; Medicine; Outcome; Participant; Pathogenesis; Patients; Population; Prevention; Protocols documentation; Recruitment Activity; Research; Research Personnel; Research Priority; Sexual Partners; Sexually Transmitted Diseases; Therapeutic Clinical Trial; Time; Translational Research; Universities; Vaccines; antiretroviral therapy; clinical research site; drug development; high risk; improved; transmission process

DESCRIPTION (provided by applicant): This application describes the University of California, San Diego (UCSD) Department of Medicine (DOM) HIV/AIDS Clinical Trials Unit (CTU) and two Clinical Research Sites (CRSs), one affiliated with the AIDS Clinical Trials Group (ACTG) Network and one with the HIV Prevention Trials Network (HPTN). The Administrative Core of the CTU will be located at the UCSD Antiviral Research Center on the UCSD Medical Center Hillcrest Campus. The UCSD CTU is affiliated, by invitation, with the proposed ACTG and HPTN Leadership Group applications. The ACTG CRS will conduct therapeutic clinical trials developed by the ACTG, targeting HIV-1-infected adult and older adolescent patients recruited from the San Diego County area, concentrating on studies in the high priority areas of translational research, new antiretroviral drug development, optimizing antiretroviral therapy and the clinical management of HIV-1 disease and its complications and co-infections, pathogenesis and treatment of acute HIV-1 infection and drug resistant HIV-1, and the evaluation of candidate HIV-1 vaccines as immunotherapeutic agents in individuals with chronic established HIV-1 infection. The HPTN CRS will conduct clinical trials developed by the HPTN, targeting predominantly HIV-uninfected but high-risk participants drawn from the San Diego County area, as well as HIV-1-infected patients participating in ACTG therapeutic clinical trials ("prevention for positives" initiatives) in collaboration with the ACTG. The HPTN CRS will concentrate on studies of antiretroviral treatment of acute HIV-1 infection to reduce transmission in this high-risk population, and of behavioral interventions to reduce transmission of HIV-1 and sexually transmitted infections in both HIV-uninfected and chronically infected individuals and their sexual partners. The CTU will initially devote 75% of its research effort on clinical trials implemented by the ACTG and 25% effort on clinical trials conducted through the HPTN, in order to accommodate the large complement of research participants continuing in ACTG studies through the transition period in year 1. These proportions will shift over time as new protocols are implemented and ongoing protocols are completed. Both CRSs will contribute scientifically to each Network through new investigator-initiated studies proposed in the new grant period in these research priority areas, and will further contribute to Network administrative and scientific leadership for both the ACTG and HPTN. The outcome of the proposed research will contribute substantially to halting the spread of HIV/AIDS and to improving the lives of those already infected with HIV-1. ADMINISTRATIVE COMPONENT:

描述（由申请人提供）：本申请描述了加利福尼亚大学，圣地亚哥分校（UCSD）医学系（DOM）HIV/AIDS临床试验单位（CTU）和两个临床研究地点（CRSS），一个隶属于AIDS临床试验组（ACTG）网络（ACTG）网络，HIV预防试验试验网络（ACTG）网络（HEPTN）。 CTU的行政核心将位于UCSD医疗中心Hillcrest校园的UCSD抗病毒研究中心。 UCSD CTU与拟议的ACTG和HPTN领导力小组应用程序有关。 The ACTG C​​RS will conduct therapeutic clinical trials developed by the ACTG, targeting HIV-1-infected adult and older adolescent patients recruited from the San Diego County area, concentrating on studies in the high priority areas of translational research, new antiretroviral drug development, optimizing antiretroviral therapy and the clinical management of HIV-1 disease and its complications and co-infections, pathogenesis and treatment of acute HIV-1 infection and drug耐药性HIV-1，以及对慢性HIV-1感染个体中候选HIV-1疫苗作为免疫治疗剂的评估。 HPTN CRS将进行由HPTN开发的临床试验，主要针对从圣地亚哥县地区吸引的HIV未感染但高风险的参与者，以及与ACTG合作的ACTG治疗临床试验（预防积极性的预防效果）的ACTG治疗治疗临床试验（“预防效果”）。 HPTN CRS将集中于急性HIV-1感染的抗逆转录病毒治疗的研究，以减少这种高风险人群的传播，以及减少HIV-1和HIV-1的传播和性传播感染的行为干预措施。 CTU最初将将其研究工作的75％用于ACTG实施的临床试验，并在通过HPTN进行的临床试验上进行25％的努力，以适应1年级的ACTG研究中继续进行ACTG研究的大量研究参与者。随着时间的推移，这些比例将随着时间的推移而改变，因为新的协议已实施并完成了计划。这两个CRS将通过在这些研究优先领域的新赠款期间提出的新研究人员提出的新研究人员为每个网络提供科学贡献，并将进一步为ACTG和HPTN的网络行政和科学领导力做出贡献。拟议研究的结果将有助于停止艾滋病毒/艾滋病的传播，并改善已经感染了HIV-1的人的生活。 管理组件：