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）：本申请描述了加州大学圣地亚哥分校 (UCSD) 医学部 (DOM) HIV/AIDS 临床试验单位 (CTU) 和两个临床研究中心 (CRS)，其中一个隶属于 AIDS 临床研究中心试验组 (ACTG) 网络和艾滋病毒预防试验网络 (HPTN) 之一。 CTU 的行政核心将设在加州大学圣地亚哥分校医学中心 Hillcrest 校区的抗病毒研究中心。 UCSD CTU 应邀请加入拟议的 ACTG 和 HPTN 领导小组申请。 ACTG C​​RS 将开展 ACTG 开发的治疗性临床试验，针对从圣地亚哥县地区招募的 HIV-1 感染成人和老年青少年患者，重点研究转化研究、新抗逆转录病毒药物开发、优化HIV-1 疾病及其并发症和合并感染的抗逆转录病毒治疗和临床管理，急性 HIV-1 感染和耐药 HIV-1 的发病机制和治疗，以及候选 HIV-1 疫苗的评估慢性 HIV-1 感染个体的免疫治疗药物。 HPTN CRS 将开展由 HPTN 开发的临床试验，主要针对来自圣地亚哥县地区的未感染 HIV 的高风险参与者，以及参加 ACTG 治疗临床试验（“预防阳性结果”）的 HIV-1 感染患者。 ” 倡议）与 ACTG 合作。 HPTN CRS 将重点研究急性 HIV-1 感染的抗逆转录病毒治疗，以减少这一高危人群中的传播，以及行为干预研究，以减少未感染 HIV 的人和慢性感染者中 HIV-1 和性传播感染的传播和他们的性伴侣。 CTU 最初将把 75% 的研究工作投入到 ACTG 实施的临床试验上，25% 的研究工作投入到通过 HPTN 进行的临床试验上，以便在今年的过渡期内容纳继续参加 ACTG 研究的大量研究参与者1. 随着新协议的实施和正在进行的协议的完成，这些比例将随着时间的推移而发生变化。两个 CRS 将通过在这些研究优先领域的新资助期内提出的新的研究者发起的研究，为每个网络做出科学贡献，并将进一步为 ACTG 和 HPTN 的网络管理和科学领导做出贡献。拟议研究的结果将大大有助于阻止 HIV/艾滋病的传播并改善已经感染 HIV-1 的人的生活。 行政部分：