North American AIDS Cohorts Collaboration on Research and Design

描述(由申请人提供)：我们建议创建北美艾滋病研究和设计协作(NAACCORD)，以响应评估艾滋病RFA的国际数据库。NA-ACCORD旨在广泛代表美国和加拿大的艾滋病毒护理，由学术医疗中心和提供艾滋病毒初级和专科护理的社区设施组成。此外，它将经典的流行病学和临床艾滋病毒队列结合在一起，形成了一种独特而有力的合作，其中既包括艾滋病毒血清阳性者，也包括血清阴性者。NAACCORD由三个主要核心--行政、数据管理和流行病学/生物统计--组成，为有效的区域数据收集和管理提供基础设施，并进行分析以回答重要的科学问题。对我们的结构至关重要的是具有高水平科学和方法专业知识以及艾滋病毒临床经验的调查人员的合作，以确定区域内和区域间的重要问题，并设计和实施回答这些问题所需的分析。我们的核心目标旨在回答我们认为对北美艾滋病毒感染的当代治疗最关键的问题。由于对艾滋病毒的耐药性，北美越来越多的艾滋病毒感染者接受了多种抗逆转录病毒(ARV)方案，几乎没有明显的继续治疗的选择。对这些患者的最佳管理尚不清楚，在解决这一问题时存在大量的方法学挑战。随着耐受性、毒性和剂量的变化，抗逆转录病毒药物选择的迅速扩大，使得何时开始抗逆转录病毒药物和抗逆转录病毒治疗的最佳顺序的问题成为目前需要解决的重要问题。其他目标将利用我们合并的大量样本和后续行动的持续时间，专注于识别新的艾滋病毒治疗方法中不常见的不良事件、恶性肿瘤的发展和老龄化对艾滋病毒治疗反应的影响等长期问题，开发新的艾滋病毒观察性研究方法，并将我们的联合样本储存库用于药物遗传学和其他过渡性研究。适当地，我们的目标与北美最相关；然而，它们也将推广到其他可提供HAART的地区(即西欧)，并将在过渡和发展中地区发展时为未来的艾滋病毒实践提供信息。

DESCRIPTION (provided by applicant): We propose to create the North American AIDS Cohort Collaboration on Research and Design (NAACCORD) in response to the International Databases to Evaluate AIDS RFA. The NA-ACCORD is designed to be widely representative of HIV care in the United States and Canada, and is comprised of both academic medical centers and community-based facilities that deliver HIV primary and specialty care. Further, it combines classical epidemiologic and clinical HIV cohorts in a unique and robust collaboration that includes both HIV-seropositive and seronegative persons. The NA-ACCORD consists of three major Cores - Administrative, Data Management, and Epidemiology/Biostatistics - that provide an infrastructure for efficient regional data collection and management, and the conduct of analyses to answer scientific questions of importance. Critical to our structure is the collaboration of investigators with a high level of scientific and methodologic expertise and HIV clinical experience to both identify questions of intraregional and interregional importance, and design and implement the analyses necessary to answer these questions. Our Core Aims are designed to answer questions that we have identified as most critical to the contemporary treatment of HIV-infection in North America. A large and growing number of HIV-infected persons in North America have received multiple antiretroviral (ARV) regimens with few apparent options for continuing treatment because of HIV resistance. The optimal management of these patients is unclear, and there are substantial methodologic challenges in addressing this issue. The rapid expansion of ARV options, with changes in tolerability, toxicity and dosing, make questions about when to begin ARVs and optimal sequencing of ARV therapy important to now address. Additional aims will leverage our combined large sample size and duration of follow-up to focus on identifying uncommon adverse events from new HIV therapies, long-term issues such as development of malignancy and effects of aging on HIV therapeutic response, developing new methods for observational HIV research and using our combined specimen repositories for pharmacogenetic and other transitional research. Appropriately, our Aims are most relevant to North America; however, they will also be generalizable to other regions where HAART is available (i.e., Western Europe), and will inform future HIV practice as it evolves in transitional and developing regions.