Stanford AIDS Clinical Trials Unit

描述（由申请人提供）：斯坦福大学艾滋病临床试验组（CTU）和病毒学支持实验室（VSL）自1987年成立以来一直隶属于艾滋病临床试验组，并已招募了1000多名患者参加ACTG试验。在此期间，斯坦福大学的研究人员在ACTG中担任了100多个不同的领导职务，并通过这些努力为艾滋病毒感染的治疗做出了重大贡献。我们CTU的调查人员和工作人员现在准备在重组临床试验网络的背景下建立这一科学贡献的记录。斯坦福CTU主要专注于开发、评估和优化用于治疗和长期管理HIV-1感染的联合抗逆转录病毒药物治疗（ART），包括使用新型药物和技术来监测治疗效果。我们的小组对HIV-1耐药性的基本机制和临床意义特别感兴趣。Stanford VSL专注于非进化支B分离株的耐药性和亚型多样性研究，已被国际ACTG和ACTG网络申请指定为耐药参考测试实验室。此外，斯坦福大学的研究小组还开发了一个数据库，将HIV治疗历史和治疗结果与基因型和表型耐药性模式联系起来。管理“高维”数据（如耐药性数据和药物基因组学数据）的先进信息学数据库可能会成为我们了解健康和疾病的决定因素、对治疗的反应和药物毒性风险的日益重要的资源，我们将在未来5-10年向前发展。斯坦福CTU包括三个临床研究站点，患者来自不同种族和社会群体：(i)帕洛阿尔托的斯坦福大学积极护理诊所，（ii）圣何塞中部圣克拉拉谷医疗中心的PACE诊所，以及（iii）圣马特奥医疗中心的圣马特奥县艾滋病项目运营的爱迪生诊所。通过这一系列的站点，我们在ACTG试验中招募的代表性不足的族裔群体和妇女总能超过我们的社区目标。虽然这种工作安排已经成功地进行了10多年，但本文所述的进一步合并和精简将确保拟议的反恐组和应急反应系统更加有效。

DESCRIPTION (provided by applicant): The AIDS Clinical Trials Unit (CTU) and Virology Support Laboratory (VSL) at Stanford University have been affiliated with the AIDS Clinical Trials Group since its inception in 1987 and has enrolled well over 1000 patients into ACTG trials. During this time Stanford investigators have served in man> different leadership capacities within the ACTG and have made significant contributions to the treatment of HIV infection through these efforts. Our CTU investigators and staff are now poised to build on this record cf scientific contribution within the context of the restructured clinical trials network. The Stanford CTU focuses primarily on the development, evaluation and optimization of combination antiretroviral drug therapy (ART) for the treatment and long-term management of HIV-1 infection including the use of novel agents and technologies for monitoring treatment efficacy. Our group has a particular interest in the basic mechanisms and clinical implications of drug resistance in HIV-1. The Stanford VSL is focused on drug resistance and subtype diversity of non-clade B isolates and has been designated as the drug resistance reference testing laboratory in the International-ACTG and ACTG network application. In addition, the Stanford group has developed a database which links HIV treatment histories and treatment outcomes to genotypic and phenotypic drug resistance patterns. Advanced informatics databases that manage "high-dimensional" data- like drug resistance data and pharmacogenomics data will likely become increasingly important resources for our understanding of the determinates of health and disease, response to treatment and risk of drug toxicities as we move forward in the next 5-10 years. The Stanford CTU comprises three Clinical Research sites with ethnically and socially diverse patient populations: (i) Stanford University's Positive Care Clinic in Palo Alto, (ii) The PACE Clinic at Santa Clara Valley Medical Center in central San Jose, and (iii) The Edison Clinic, run by the San Mateo County AIDS Program at San Mateo Medical Center. Through this constellation of sites we have always exceeded our community-based targets for under represented ethnic groups and women in ACTG trial enrollment. Although this working arrangement has been successful for over 10 years, further consolidations and streamlining described here will ensure that the proposed CTU and CRSs will be even more efficient. ADMINISTRATIVE COMPONENT: