Cornell Clinical Trials Unit

描述(由申请人提供)：估计有100万美国人(以及超过9万名纽约市居民)感染了艾滋病毒。尽管最近取得了进展，但艾滋病毒/艾滋病仍然是临床研究的一个重要领域。本申请描述了康奈尔临床试验单位(CCTU)，这是一个艾滋病毒/艾滋病治疗临床试验单位，根据事先协议，它将隶属于3个艾滋病临床试验小组(ACTG)网络。康奈尔大学的部门由一个整体行政核心和两个CRSS组成：康奈尔住宅区和康奈尔切尔西。核心单位为CRSS提供中央研究支持，包括：调查监督、行政管理、研究协调、数据管理、监管、外联和药房服务。两个临床研究网站CRSS位于纽约市的不同地区，在艾滋病毒血清阳性率最高的社区或附近：康奈尔住宅区靠近东哈莱姆区(血清阳性率为2.5%)，康奈尔-切尔西位于切尔西-克林顿区(血清阳性率为4.1%)。这两个CRS服务于不同的患者群体，其中包括大量的女性、有色人种(非裔美国人、亚裔和拉丁裔)以及来自不同风险群体的青少年/年轻人(异性恋者、注射吸毒者、与男性发生性行为的男性)。康奈尔大学在ACTG拥有17年的经验，在不同领域拥有广泛的科学和临床研究经验，包括：抗逆转录病毒药物和策略；艾滋病毒并发症和抗逆转录病毒疗法；基于免疫的疗法，包括疫苗；混合感染(例如，乙肝、丙型肝炎和人乳头状瘤病毒)；神经系统并发症；依从性和预后；艾滋病毒感染的妇女和妊娠；以及预防艾滋病毒的母婴传播。康奈尔大学的单位将为ACTG的优先研究领域作出贡献：转化研究/药物开发；优化临床管理，包括合并症；治疗性疫苗研究和开发；以及预防母婴传播。康奈尔大学的研究人员在ACTG委员会、ACTG委员会和ACTG礼宾团队担任领导职务(包括11项当前研究的礼宾领导)。康奈尔大学与海地关系密切，并在指导和培训海地艾滋病毒/艾滋病临床调查人员方面发挥了积极作用。康奈尔单位的一个主要重点是社区外联和教育，康奈尔社区咨询委员会积极代表我们多样化的社区。 管理组件：

DESCRIPTION (provided by applicant): An estimated 1 million Americans (and more than 90,000 New York City residents) have HIV infection. Despite recent advances, HIV/AIDS remains an important area for clinical investigation. This application describes the Cornell Clinical Trials Unit (CCTU), an HIV/AIDS therapeutic clinical trials unit that will affiliate with the 3 AIDS Clinical Trials Group (ACTG) network by prior agreement. The Cornell unit consists of an overall administrative core and two CRSs: Cornell Uptown and Cornell Chelsea. The core unit provides central research support to the CRSs including: investigative oversight, administration, study coordination, data management, regulatory, outreach, and pharmacy services. The two clinical research sites CRSs are located in different parts of New York City, in or close to the neighborhoods with the highest HIV seroprevalence rates: Cornell Uptown is located close to East Harlem (2.5% seroprevalence) and Cornell Chelsea is located in Chelsea-Clinton (4.1% seroprevalence). The two CRSs serve distinct patient populations that include significant numbers of women, people of color (African Americans, Asians, and Latinos), and adolescents/young adults from diverse risk groups (heterosexuals, injection drug users, men who have sex with men). With 17 years experience in the ACTG, the Cornell unit has broad scientific and clinical research experience in diverse areas including: antiretroviral agents and strategies; complications of HIV and antiretroviral therapies; immune-based therapies, including vaccines; co-infections (e.g. hepatitis B, hepatitis C, and human papillomavirus); neurological complications; adherence and outcomes; HIV-infected women and pregnancy; and prevention of mother-to-child transmission of HIV. The Cornell unit will contribute to the priority research areas of the ACTG: translational research/drug development; optimization of clinical management, including co-morbidities; therapeutic vaccine research and development; and prevention of mother-to-child transmission. Cornell investigators serve in ACTG leadership positions, on ACTG committees, and ACTG protocol teams (including protocol leadership for 11 current studies). Cornell has strong ties to Haiti and plays an active role in mentoring and training Haitian HIV/AIDS clinical investigators. A major focus of the Cornell unit is community outreach and education and the Cornell Community Advisory Board is active in representing our diverse community. ADMINISTRATIVE COMPONENT: