Stanford AIDS Clinical Trials Unit

描述（由申请人提供）：艾滋病临床试验单位（CTU）和病毒学支持实验室（VSL）在斯坦福大学一直隶属于艾滋病临床试验组自1987年成立以来，已招募了1000多名患者进入ACTG试验。在此期间，斯坦福大学的研究人员在ACTG中担任了不同的领导职务，并通过这些努力为艾滋病毒感染的治疗做出了重大贡献。我们的CTU研究人员和工作人员现在准备在重组的临床试验网络的背景下建立这一科学贡献的记录。斯坦福大学CTU主要致力于开发、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疗法（ART），包括使用新药物和技术监测治疗效果。我们的团队对HIV-1耐药性的基本机制和临床意义特别感兴趣。斯坦福大学VSL专注于非进化枝B分离株的耐药性和亚型多样性，并已被指定为国际ACTG和ACTG网络应用中的耐药性参考检测实验室。此外，斯坦福大学小组还开发了一个数据库，将艾滋病毒治疗史和治疗结果与基因型和表型耐药模式联系起来。随着我们在未来5-10年的发展，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、治疗反应和药物毒性风险的决定因素的越来越重要的资源。斯坦福大学CTU包括三个临床研究中心，其患者人群种族和社会背景各不相同：（i）位于帕洛阿尔托的斯坦福大学积极护理诊所，（ii）位于圣何塞市中心圣克拉拉谷医疗中心的PACE诊所，以及（iii）由圣马特奥县艾滋病项目在圣马特奥医疗中心运营的爱迪生诊所。通过这一系列研究中心，我们在ACTG试验入组中始终超过了代表性不足的种族群体和女性的社区目标。虽然这项工作安排已成功运作超过10年，但本文件所述的进一步合并和精简工作，将确保拟议的职工股和中央登记系统的效率更高。 行政部门：

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: