ACUTE HIV INFECTION AND EARLY DISEASE RESEARCH NETWORK

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 1.本议定书要解决的研究问题 AIEDRP议定书是在1996年制定的，当时我们开始了解艾滋病毒感染的早期自然病史的重要性。我们的兴趣是培养一批患者，在他们中我们可以研究艾滋病毒感染的自然历史和对治疗的反应。我们的兴趣包括： 1.设定病毒设定值 2.寄主反应机制 3.有效的抗逆转录病毒疗法对疾病进展的影响 从开始到2002年5月，NIAID计划逐步取消该方案，不再允许新的登记，92名患有急性或早期艾滋病毒感染的参与者参加了登记。下文概述的研究计划描述了将遵循所有现有参与者的方式。 2.研究的基本原理 研究动机 美国国家过敏症和传染病研究所(NIAID)的急性HIV感染和早期疾病研究计划(AIEDRP)是为了开发、实施和评估来自急性或最近感染HIV-1的受试者的发病机制和治疗干预的创新研究数据。参与AIEDRP的研究人员使用干预措施，如有效的联合抗逆转录病毒疗法、免疫调节剂、结构化治疗中断(STI)、治疗性免疫或其他新方法。治疗是在艾滋病毒-1感染的急性和早期阶段启动或实施的。目的是评估HIV-1致病的免疫学和病毒学机制，急性HIV-1感染引起或与之相关的免疫失调的发病机制，以及在急性或最近感染的情况下立即或延迟抗病毒治疗后HIV-1疾病的病程。AIEDRP进行的调查还包括在急性或最近感染期间选择不接受抗逆转录病毒治疗的个人，在某些情况下，这些人在上述开放标签发病机制和治疗研究中充当未经治疗的对照。 AIEDRP的另一个主要目标是评估接受上述干预措施测试的个人的长期临床、病毒学和免疫学结果。由AIEDRP支持的研究单位在其研究研究中纳入了基础实验室和转化实验室以及临床部分。这将使他们能够在最新进展的基础上更好地了解艾滋病毒/艾滋病的发病机制、新的有效和新的抗逆转录病毒疗法、更有效的工具来测量和监测艾滋病毒-1在血液和组织储存库中的复制，以及这些储存库中的病毒复制对免疫功能和病毒进化的影响，包括抗药性的发展。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. 1. Research Questions to be addressed by this protocol The AIEDRP Protocol was developed in 1996 as we began to understand the importance of the early natural history of HIV infection. Our interest was to develop a cohort of patients in whom we could study the natural history of HIV infection and response to therapy. Our interests included: 1. establishment of viral set point 2. mechanisms of host response 3. impact of potent antiretroviral therapy on disease progression From inception until May, 2002, when the protocol was scheduled for phase-out by NIAID and new enrollment was no longer permitted, ninety-two participants with acute or early HIV infection were enrolled. The research plan outlined below describes the manner in which all current participants will be followed. 2. Rationale for research Motivation for research The Acute HIV Infection and Early Disease Research Program (AIEDRP) of the National Institute of Allergy and Infectious Diseases (NIAID) was established to develop, implement and evaluate data derived from innovative studies of pathogenesis and treatment interventions for subjects acutely or recently infected with HIV-1. Investigators participating in the AIEDRP use interventions, such as potent combination antiretroviral therapies, immunomodulators, structured treatment interruptions (STI), therapeutic immunization, or other novel approaches. Therapies are initiated or administered in the acute and early phases of HIV-1 infection. Aims are to evaluate the immunologic and virologic mechanisms by which HIV-1 causes disease, the pathogenesis of immune dysregulation caused by or associated with acute HIV-1 infection, and the course of HIV-1 disease following immediate or delayed antiviral treatment in the setting of acute or recent infection. Investigations conducted by the AIEDRP also include individuals who elect not to receive antiretroviral therapy during acute or recent infection, and these individuals, in some instances, serve as untreated controls for the open-label pathogenesis and treatment studies described above. A further major goal of the AIEDRP is to evaluate the long-term clinical, virologic and immunologic outcomes of individuals in whom the interventions listed above are tested. The research units supported by the AIEDRP have incorporated both basic and translational laboratory as well as clinical components in their research studies. This will allow them to build upon recent advances to better understand HIV/AIDS pathogenesis, new potent and novel antiretroviral therapies, more effective tools for measuring and monitoring replication of HIV-1 in blood and tissue reservoirs, and the impact of viral replication in these reservoirs on immunologic function and viral evolution, including the development of drug resistance.