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)和两个临床研究网站(CRSS)，一个附属于艾滋病临床试验小组(ACTG)网络，一个附属于艾滋病毒预防试验网络(HPTN)。CTU的行政核心将设在加州大学圣迭戈分校医疗中心山顶校区的加州大学圣迭戈分校抗病毒研究中心。加州大学圣迭戈分校CTU应邀请加入了拟议的ACTG和HPTN领导小组申请。ACTG CRS将进行由ACTG开发的治疗性临床试验，目标是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，集中在以下优先领域的研究：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HIV-1疾病及其并发症和合并感染的临床管理、急性HIV-1感染和耐药HIV-1的发病机制和治疗，以及评估候选HIV-1疫苗作为慢性HIV-1感染者的免疫治疗剂。HPTN CRS将进行由HPTN开发的临床试验，对象主要是来自圣地亚哥县地区的艾滋病毒未感染但高危参与者，以及与ACTG合作参加ACTG治疗临床试验(“阳性预防”倡议)的HIV-1感染患者。HPTN CRS将集中研究急性HIV-1感染的抗逆转录病毒治疗，以减少在这一高危人群中的传播，并研究行为干预措施，以减少未感染艾滋病毒和长期感染艾滋病毒的个人及其性伴侣的艾滋病毒-1和性传播感染的传播。CTU最初将把75%的研究精力用于ACTG实施的临床试验，25%的精力用于通过HPTN进行的临床试验，以适应在第一年过渡期内继续参加ACTG研究的大量研究参与者。随着新方案的实施和正在进行的方案的完成，这些比例将随着时间的推移而变化。这两个研究中心将通过在新的赠款期间提出的在这些研究优先领域开展的新的研究人员发起的研究，为每个网络作出科学贡献，并将进一步促进网络的行政和科学领导作用，使ACTG和HPTN都能发挥领导作用。拟议研究的结果将大大有助于阻止艾滋病毒/艾滋病的传播，并改善已经感染艾滋病毒-1的人的生活。 管理组件：

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: