ACUTE HIV INFECTION AND EARLY DISEASE RESEARCH NETWORK

急性艾滋病毒感染和早期疾病研究网络

• 批准号: 7604534
• 负责人: Joseph B. Margolick
• 金额: $ 5.19万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604534
• 关键词: AIDS/HIV problem; Acute; Address; Antiviral Agents; Blood; Clinical; Computer Retrieval of Information on Scientific Projects Database; Data; Development; Disease; Disease Progression; Drug resistance; Enrollment; Evolution; Funding; Goals; Grant; HIV Infections; HIV-1; Immune; Immune response; Immunization; Immunologics; Immunomodulators; Individual; Infection; Institution; Interruption; Intervention; Investigation; Label; Laboratories; Measures; Monitor; Motivation; National Institute of Allergy and Infectious Disease; Natural History; Outcome; Participant; Pathogenesis; Patients; Phase; Protocols documentation; Research; Research Personnel; Resources; Schedule; Source; Structure; Testing; Therapeutic; Tissues; United States National Institutes of Health; Viral; Viral Physiology; antiretroviral therapy; cohort; innovation; interest; novel; novel strategies; programs; research study; response; tool

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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 1.本方案要解决的研究问题 AIEDRP协议于1996年制定，因为我们开始了解HIV感染早期自然史的重要性。我们的兴趣是开发一个患者队列，我们可以在其中研究HIV感染的自然史和对治疗的反应。我们的兴趣包括： 1. 病毒设定点建立 2. 寄主反应机制 3. 强效抗逆转录病毒治疗对疾病进展的影响 从开始到2002年5月，当NIAID计划逐步淘汰该方案并且不再允许新的招募时，招募了92名患有急性或早期HIV感染的参与者。下文概述的研究计划描述了将跟踪所有当前参与者的方式。 2.研究理由 研究动机 国家过敏和传染病研究所（NIAID）的急性HIV感染和早期疾病研究计划（AIEDRP）旨在开发、实施和评估来自急性或近期感染HIV-1受试者的发病机制和治疗干预创新研究的数据。 参与AIEDRP的研究者使用干预措施，如强效抗逆转录病毒联合疗法、免疫调节剂、结构性治疗中断（STI）、治疗性免疫接种或其他新方法。在HIV-1感染的急性和早期阶段开始或给予治疗。目的是评估HIV-1引起疾病的免疫学和病毒学机制，由急性HIV-1感染引起或与急性HIV-1感染相关的免疫失调的发病机制，以及在急性或近期感染的情况下立即或延迟抗病毒治疗后的HIV-1疾病过程。 AIEDRP进行的调查还包括在急性或近期感染期间选择不接受抗逆转录病毒治疗的个体，在某些情况下，这些个体作为上述开放标签发病机制和治疗研究的未治疗对照。 AIEDRP的另一个主要目标是评估接受上述干预试验的个体的长期临床、病毒学和免疫学结局。 AIEDRP支持的研究单位在其研究中纳入了基础和转化实验室以及临床部分。这将使他们能够利用最新的进展，更好地了解艾滋病毒/艾滋病的发病机制，新的有效和新颖的抗逆转录病毒疗法，更有效的工具来测量和监测血液和组织水库中的HIV-1复制，以及这些水库中病毒复制对免疫功能和病毒进化的影响，包括耐药性的发展。