Partners Healthcare Systems/Harvard Medical School/Boston Medical Center AIDS CTU

描述（由申请人提供）： Partners Healthcare Systems/哈佛医学院/波士顿医学中心艾滋病临床试验单位（以前称为哈佛医学院/波士顿医学中心（HMS/BMC）艾滋病CTU）由附属于艾滋病临床试验组（ACTG）网络领导小组的临床研究中心（CRS）联盟组成。CRS位于马萨诸塞州总医院（MGH）、布里格姆妇女医院（BWH）、贝斯以色列女执事医疗中心（BIDMC）和波士顿医疗中心（BMC），行政部门位于MGH。在其19年的历史中，HMS/BMC AIDS CTU的研究人员为艾滋病的治疗研究做出了重大贡献，并在ACTG的科学领导中发挥了关键作用：证明联合抗逆转录病毒治疗，蛋白酶抑制剂治疗和HCV联合治疗在合并感染者中的临床疗效的关键研究都是由HMS/BMC AIDS CTU研究人员领导的。我们提出了一个全面的，综合的临床和转化研究计划，解决网络领导小组RFA中描述的六个优先领域中的五个（AI-05-001），包括：1）转化研究/药物开发; 2）优化临床管理，包括合并症; 3）疫苗开发（治疗性疫苗）; 4）预防母婴传播（与波士顿IMPAACT临床试验单位合作）;和5）预防HIV-1感染。此外，合作伙伴/哈佛/BMC艾滋病工作组与博茨瓦纳哈博罗内工作组和中国医学科学院/北京协和医学院工作组建立了指导伙伴关系，合作伙伴/哈佛/BMC艾滋病工作组的研究人员和研究人员通过这些伙伴关系提供ACTG试验实施方面的培训和指导。伙伴/哈佛/BMC艾滋病工作队的首要任务是从传统上代表性不足的少数群体中征聘妇女和受试者。这一目标是由我们的两个CRS（BWH和BMC在主要少数民族社区的位置，并与我们的社区咨询委员会协调外展工作的帮助。本申请中提出的研究结果将通过改善临床护理、预防或延缓HIV疾病进展、降低或消除与HIV-1感染及其相关并发症相关的发病率和死亡率，对公共卫生产生深远影响。 行政部分

DESCRIPTION (provided by applicant): The Partners Healthcare Systems/Harvard Medical School/Boston Medical Center AIDS Clinical Trials Unit, previously known as the Harvard Medical School/Boston Medical Center (HMS/BMC) AIDS CTU, comprises a consortium of clinical research sites (CRS) affiliated with the AIDS Clinical Trials Group (ACTG) network leadership group. The CRSs are located at Massachusetts General Hospital (MGH), Brigham and Women's Hospital (BWH), Beth Israel-Deaconess Medical Center (BIDMC), and Boston Medical Center (BMC), with an administrative component located at MGH. Throughout its 19-year history, investigators of the HMS/BMC AIDS CTU have made major contributions to therapeutic research in AIDS and have played a critical role in the scientific leadership of the ACTG: pivotal studies demonstrating clinical efficacy of combination antiretroviral therapy, protease inhibitor therapy, and combination therapy of HCV in co-infected persons all have been led by HMS/BMC AIDS CTU investigators. We propose a comprehensive, integrated clinical and translational research program that addresses five of the six priority areas described in the Network Leadership Group RFA (AI-05-001), including: 1) translational research/drug development; 2) optimization of clinical management, including co-morbidities; 3) vaccine development (therapeutic vaccines); 4) prevention of mother-to-child transmission (in collaboration with the Boston IMPAACT Clinical Trials Unit); and 5) prevention of HIV-1 infection. In addition, the Partners/Harvard/BMC AIDS CTU has formed mentoring partnerships with the Botswana CTU in Gaborone and the Chinese Academy of Medical Sciences/Peking Union Medical College CTU in Beijing through which investigators and research staff of the Partners/Harvard/BMC AIDS CTU provide training and guidance in the conduct of ACTG trials. Recruitment of women and subjects from traditionally underrepresented minority groups is a top priority of the Partners/Harvard/BMC AIDS CTU. This goal is aided by location of two of our CRSs (BWH and BMC in predominantly minority neighborhoods, and outreach efforts coordinated with our Community Advisory Board. Results of the studies proposed in this application will have a profound impact on public health by improving clinical care, preventing or delaying HIV disease progression, and reducing or eliminating the morbidity and mortality associated with HIV-1 infection and its associated complications. ADMINISTRATIVE COMPONENT