ACUTE HIV INFECTION AND EARLY DISEASE RESEARCH PROGRAM (AIEDRP)

这个子项目是许多利用 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。 本方案的目的是建立一个参与HIV-1发病机制研究的HIV-1感染者队列，在个体AIEDRP临床试验中评价治疗策略的研究，以及同意接受本方案随访的推迟治疗的受试者。入组受试者将在数据库中根据急性或近期HIV-1感染进行分层。这将允许跨方案分析，以解决与急性或近期HIV-1感染的发病机制和治疗相关的特定长期问题。入组的受试者可能为多项分析提供数据。本方案的主要目的是确定在急性或早期感染期间被诊断的受试者的长期病毒学、免疫学和临床结局以及并发症，这些受试者要么立即开始治疗，要么推迟治疗，直到慢性HIV-1疾病病程中的某个未来时间点。 建立AIEDRP长期队列的基本原理是，即使在受试者完成了有时限的临床试验或干预后，也要持续随访并收集重要结局，这对于评价在急性和/或近期HIV-1感染背景下进行的干预的长期影响非常重要。 入组本项目主方案的受试者也将共同入组本方案以收集数据。本方案要求提交基线访视、第2周、第4周、第12周和此后每12周一次的数据，直至第168周（研究3年），然后受试者将在研究期间每24周一次接受访视。如果在研究期间的任何时间进行了额外访视，则将CRF存在的所有相关数据提交至AIEDRP CORE 01数据库。 CORE 01方案的总体目标是为急性和早期HIV-1感染个体提供统一的定义和访视时间表，以输入临床数据库。 AIEDRP CORE 01数据库方案将建立一组HIV-1感染者，这些受试者正在参与HIV-1发病机制研究、在单个研究中心AIEDRP临床试验中评价治疗策略的研究，以及选择推迟治疗但同意接受本方案随访的受试者。 入组受试者将在数据库中根据急性或近期HIV-1感染进行分层。 以明确的方式收集前瞻性数据将允许跨方案分析，以解决与急性或近期HIV-1感染的发病机制和治疗相关的特定长期科学问题。 入组的受试者可能为多项分析提供数据。 该方案的主要目的是确定在急性或早期HIV-1感染期间被诊断的受试者的长期病毒学、免疫学和临床结局以及并发症，这些受试者要么立即开始治疗，要么推迟治疗，直到慢性HIV-1疾病过程中的某个未来时间点。 目前或以前在AIEDRP中进行的发病机制和治疗干预临床试验的结果有助于并将继续有助于我们了解HIV-1疾病的发病机制。 然而，HIV-1发病机制的新发展，用于监测血浆和组织储库中HIV-1复制的改进工具和机制的可用性，以及新型抗逆转录病毒疗法和治疗策略的开发，将需要在急性或近期感染的受试者中对这些进行持续评估。 AIEDRP CORE 01数据库协议将促进在AIEDRP各单位进行的研究的纵向和前瞻性计划的荟萃分析或跨协议分析，其中有关特定抗逆转录病毒或治疗干预方案或策略的信息，用于实时监测抗逆转录病毒效果和耐药性发展的新工具的使用，和影响治疗反应的因素，以解决和比较管理急性或最近感染HIV-1的个人的长期战略方法。 本CORE 01方案将提供一个框架，用于评价各个研究中心和方案中关于初始治疗方案比较、确定病毒载量或转换药物或药物组合的其他阈值以及药物暴露对治疗结局的贡献的长期战略问题。 与免疫保护和重建以及病原体特异性免疫有关的问题也可以在正在进行和评价的干预战略和短期发病机制研究的背景下加以解决。 包括急性或近期感染背景下各种治疗干预措施的前瞻性纵向数据库的开发也将允许检查与各种临床结局相关的人口统计学和宿主特征。

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. The purpose of this protocol is to establish a cohort of of HIV-1 infected individuals who are participating in studies of HIV-1 pathogenesis, studies evaluating theraputic strategies in individual AIEDRP clinical trials amp; subjects who defer therapy who agree to be followed in this protocol. Enrolled subjects will be stratified in the database with regard to acute or recent HIV-1 infection. This will allow cross protocol analysis to address specific long term questions related to the pathogenesis and treatment of acute or recent HIV-1 infection. Enrolled subjects may contribute data to multiple analyses. The primary aim of this protocol is to determine the long term virologic, immunologic and clinical outcomes and complications for subjects who were diagnosed during acute or early infection and who either begin therapy immediately, or defer therapy until some future point in the course of chronic HIV-1 disease. The rationale for establishing the AIEDRP long term cohort is to continue to follow and collect important outcomes over time, even after subjects have completed a time-limited clinical trial or intervention, will be important in evaluating the long-term impact of interventions that take place in the setting of acute and/or recent HIV-1 infection. Subjects who enroll in the parent protocol for this project will also co-enroll in this protocol for data collection. This protocol requires data to be submitted for baseline visit, weeks, 2, 4, 12, and every 12 weeks thereafter until week 168 (3 years on study), subjects will then have visits every 24 weeks for the duration of the study. If additional visits are made at any time during the study, all relevant data for which CRFs exist will be submitted to the AIEDRP CORE01 Data Base. The overall objective of the CORE01 protocol is to provide a uniform definition and schedule of visits for individuals with acute and early HIV-1 infection to be entered into a clinical database. The AIEDRP CORE01 Database Protocol will establish a cohort of HIV-1-infected individuals who are participating in studies of HIV-1 pathogenesis, studies evaluating therapeutic strategies in individual site AIEDRP clinical trials, and of subjects who choose to defer therapy but agree to be followed in this protocol. Enrolled subjects will be stratified in the database with regard to acute or recent HIV-1 infection. The collection of prospective data in a defined manner will allow cross-protocol analyses to address specific long-term scientific questions related to the pathogenesis and treatment of acute or recent HIV-1 infection. Enrolled subjects may contribute data to multiple analyses. The primary aim of this protocol is to determine the long-term virologic, immunologic, and clinical outcomes and complications for subjects who were diagnosed during acute or early HIV-1 infection and who either began therapy immediately, or defer therapy until some future point in the course of chronic HIV-1 disease. Results from the pathogenesis and therapeutic intervention clinical trials currently or previously conducted within the AIEDRP have contributed and continue to contribute to our understanding of the pathogenesis of HIV-1 disease. However, new developments in HIV-1 pathogenesis, the availability of improved tools and mechanisms for monitoring HIV-1 replication in plasma and tissue reservoirs, and the development of novel antiretroviral therapies and treatment strategies will require ongoing assessment of these in subjects with acute or recent infection. The AIEDRP CORE01 Database Protocol will facilitate longitudinal and prospectively planned meta-analyses or cross-protocol analyses of the studies conducted at individual AIEDRP units, in which information about specific antiretroviral or therapeutic intervention regimens or strategies, the use of new tools for real-time monitoring of antiretroviral effects and development of drug resistance, and factors that impact on treatment response will be performed to address and compare longer term strategic approaches to management of individuals acutely or recently infected with HIV-1. This CORE01 Protocol will provide the framework for evaluating across individual sites and protocols the longer term strategic questions regarding comparisons of initial treatment regimens, determination of viral load or other thresholds for switching a drug or combinations of drugs, and the contribution of drug exposure to treatment outcome. Questions related to immune preservation and reconstitution and pathogen-specific immunity can also be addressed in the context of the interventional strategies and short-term pathogenesis studies that are being conducted and evaluated. The development of a prospective, longitudinal database including a variety of therapeutic interventions in the setting of acute or recent infection will also permit examination of demographic and host characteristics that are associated with various clinical outcomes.