Center/Coordination, Analysis and Management/MACS

描述（由申请人提供）：多中心艾滋病队列研究（MACS）是一项自1984年开始进行的综合性队列研究，有助于了解HIV感染的自然历史和高效抗逆转录病毒疗法（HAART）的影响。结合遗传学、病毒学、免疫学和社会心理方法，利用标本库和参与者的长期特征，MACS支持的扩展将进一步阐明在缺乏和存在治疗的情况下HIV感染的生物学和反应，并区分年龄、HIV和HAART对临床结果的影响。MACS的理想定位是解决这些问题，因为它对6972名男性进行了长期的标准化随访，建立了广泛的标本库，并建立了一个由生活方式行为和人口统计学特征相似的未感染艾滋病毒的男性组成的适当对照组。其他优势还包括在感染前后和已知感染日期对653多名男子进行跟踪调查、经验丰富的调查人员以及在艾滋病毒疾病各方面具有专门知识的杰出合作者组成的广泛网络。该申请进一步寻求支持MACS数据分析和管理中心（CAMACS）的扩展，为MACS研究议程提供流行病学和统计方面的领导。多中心合作方面，描述治疗的有利和不利影响之间的平衡的复杂性，治疗的选择性使用以及选择适合研究问题的有效研究设计所固有的挑战，需要一个分析中心将艾滋病科学与流行病学，统计学和MACS数据管理的专业知识相结合，以成功地解决本应用程序A部分所述的科学目标。CAMACS的具体目标是提供领导和质量保证系统，以：1)协调研究计划（包括有效的沟通，研究方案和表格修订，定期介绍与科学议程相关的统计特征）；2)管理数据以促进分析（包括编辑、文档化、存储和传播）；3)在研究的设计、分析和解释方面提供统计和流行病学专业知识，并制定统计和流行病学方法；4)促进和跟踪MACS数据/样本的使用。相关性：CAMACS实施的科学伙伴关系和方法将使MACS能够回答与接受治疗的艾滋病毒人群相关的重要问题，并了解接受治疗和未经治疗的艾滋病毒感染的生物学。这项研究可能有助于预防感染，为开发有效的艾滋病毒疫苗提供相关见解，并为提高生存率和延长生命质量提供信息

DESCRIPTION (provided by applicant): The Multicenter AIDS Cohort Study (MACS), a comprehensive cohort study ongoing since 1984, has contributed to the understanding of the natural history of HIV infection and the impact of highly active antiretroviral therapies (HAART). Combining genetic, virologic, immunologic and psychosocial approaches and utilizing the repository of specimens and long-term characterization of the participants, the extension of the support of the MACS will allow further elucidation of the biology of and response to HIV infection in the absence and presence of therapies, and distinguishing the effects of age, HIV and HAART on clinical outcomes. The MACS is ideally positioned to address these issues because of long-term standardized follow-up of 6,972 men, an extensive specimen repository and an appropriate control group consisting of HIV uninfected men with similar lifestyle behaviors and demographics. Additional strengths include following over 653 men before and after infection and with known dates of infection, experienced investigators and a broad network of outstanding collaborators with expertise in all aspects of HIV disease. This application further seeks support for the extension of the Center for the Analysis and Management of the MACS Data (CAMACS) to provide epidemiologic and statistical leadership to the MACS research agenda. The multicenter collaborative aspect, the complexities of characterizing the balance between beneficial and adverse effects of therapies, the selective use of treatment and the challenges inherent in choosing efficient study designs appropriate to the research questions require an analytical center to integrate HIV science with expertise in epidemiology, statistics and data management for MACS to successfully address the scientific aims as stated in Part A of this application. The specific aims of CAMACS are to provide leadership and quality-assured systems to: 1) coordinate the research initiatives (includes effective communication, study protocol and form revision, periodic presentation of statistical characterizations pertinent to the scientific agenda); 2) manage the data to facilitate analyses (includes edit, documentation, storage, and dissemination); 3) provide statistical and epidemiological expertise in the design, analysis and interpretation of studies and to develop statistical and epidemiologic methodology; and 4) promote and track the use of MACS data/specimens. RELEVANCE: The scientific partnership and methods implemented by CAMACS will allow MACS to answer important questions relevant to treated HIV populations, and to understand the biology of treated and untreated HIV infection. This research may contribute to prevention of infection, provide insights relevant to the development of effective vaccines for HIV, and provide information to enhance the survival and quality of extended life