UCSD Department of Medicine HIV/AIDS Clinical Trials Unit

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）医学系（DOM）艾滋病毒/艾滋病临床试验单位（CTU）和两个临床研究站点（CRSs），一个隶属于艾滋病临床试验组（ACTG）网络，一个隶属于艾滋病毒预防试验网络（HPTN）。CTU的行政核心将位于加州大学圣地亚哥分校医学中心希尔克雷斯特校区的加州大学圣地亚哥分校抗病毒研究中心。UCSD CTU被邀请加入ACTG和HPTN领导小组的申请。ACTG CRS将开展由ACTG开发的治疗性临床试验，针对从圣地亚哥县地区招募的艾滋病毒-1感染的成人和老年青少年患者，重点研究转化研究、新的抗逆转录病毒药物开发、优化抗逆转录病毒治疗和艾滋病毒-1疾病及其并发症和合并感染的临床管理、急性艾滋病毒-1感染和耐药艾滋病毒-1的发病机制和治疗等高度优先领域。以及评估候选HIV-1疫苗作为慢性HIV-1感染个体的免疫治疗剂。HPTN CRS将开展由HPTN开发的临床试验，主要针对圣地亚哥县地区未感染艾滋病毒但高风险的参与者，以及与ACTG合作参加ACTG治疗性临床试验（“阳性预防”倡议）的hiv -1感染患者。HPTN CRS将集中研究急性艾滋病毒-1感染的抗逆转录病毒治疗，以减少这一高危人群的传播，以及行为干预，以减少艾滋病毒-1和性传播感染在未感染艾滋病毒和慢性感染艾滋病毒的个人及其性伴侣中的传播。CTU最初将把75%的研究投入到ACTG实施的临床试验中，25%的研究投入到HPTN进行的临床试验中，以适应在第一年的过渡期继续进行ACTG研究的大量研究参与者。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改变。两个CRSs将通过在这些研究优先领域的新拨款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。拟议的研究成果将大大有助于制止艾滋病毒/艾滋病的蔓延和改善已感染艾滋病毒-1的人的生活。

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: