Estimation of the Prevalence of Post Treatment Controllers of HIV-1 Infection Using Pooled Data from Independent Study Sites

使用独立研究中心的汇总数据估计 HIV-1 感染治疗后控制者的患病率

• 批准号: 9335722
• 负责人: SARAH E HOLTE
• 金额: $ 20.9万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-20 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9335722
• 关键词: Acute; Aftercare; CD4 Positive T Lymphocytes; California; Clinic; Comb animal structure; Data; Data Element; Data Set; Databases; Disease; Eligibility Determination; European; Evaluation; Funding; Goals; HIV; HIV Infections; HIV-1; Immunologics; Individual; Infection; Instruction; Interruption; Investigation; Meta-Analysis; Participant; Patients; Persons; Population; Prevalence; Primary Infection; Procedures; Protocols documentation; Publications; Quality Control; Recruitment Activity; Reporting; Research; Research Infrastructure; Research Personnel; Rest; Sample Size; Sampling; Site; Source; Standardization; United States National Institutes of Health; Universities; Viral; Viral Load result; Washington; base; cohort; data format; design; improved; memory CD4 T lymphocyte; patient subsets; programs; public health relevance; virology

 DESCRIPTION (provided by applicant): A recent report from the European VISCONTI group estimated that 14-15% of patients treated very early during infection were able to discontinue therapy and maintain viral suppression for several years without any therapy. This estimate of 15% is much higher than expected and requires confirmation. Since then, no other group has been able to confirm or refute this finding, most likely because very large numbers of individuals are required to find enough patients eligible for evaluation for PTC, since most patients on suppressive therapy rarely discontinue treatment. Therefore, in order to get a large enough sample size to definitively estimate the prevalence of PTC and associated factors associated with PTC it is necessary to combine data from similar but independent sources conducting research on acute and very early HIV infection. The primary goal of this project is to combine data in a standardized manner from three sources: The historical Acute Infection/Early Disease Research Program (AIEDRP) database, the University of Washington Primary Infection Cohort database and the University of California San Diego Primary Infection Cohort database. This combined database will be referred to as to the PTC Database and will be used to obtain a preliminary estimate of the percentage of PTCs in combination from the three sources, improving on the estimates that have been obtained by both the UW and UCSD groups independently. In addition, a formal protocol, based on procedures for QC and formatting identified while combining these three data sets, will be developed. This protocol will provide specific instructions on how to QC and format data for inclusion in the PTC Database. Once we establish feasibility for combing data sets with the information needed to estimate the prevalence of PTC and develop a protocol with instructions on how to prepare datasets for inclusion in the PTC Database, an R01 application is planned which will recruit additional sites to contribute data to the PTC Database. The protocol will be provided to each site so that they can prepare their individual data sets efficiently and consistently to be included in the PTC Database. This database would then be used to estimate the prevalence of PTCs and evaluate correlates and other mechanisms of PTC. Information on predictors and other features of PTCs may allow certain patients with those predictors and features to consider a treatment interruption. In addition, the identification of factors associated with PTCs could direct additionl research on finding a functional cure for HIV.

 描述(申请人提供)：欧洲维斯康蒂集团最近的一份报告估计，在感染期间很早就接受治疗的患者中，有14%-15%能够在没有任何治疗的情况下停止治疗并保持病毒抑制数年。这一15%的预估远高于预期，需要确认。从那时起，没有其他小组能够证实或驳斥这一发现，最可能的原因是需要非常大量的个人来寻找足够多的有资格接受PTC评估的患者，因为大多数接受抑制治疗的患者很少停止治疗。因此，为了获得足够大的样本量来明确估计PTC的患病率和与PTC相关的因素，有必要结合来自类似但独立来源的数据，进行关于急性和极早期艾滋病毒感染的研究。该项目的主要目标是以标准化方式合并来自三个来源的数据：历史急性感染/早期疾病研究计划(AIEDRP)数据库、华盛顿大学初级感染队列数据库和加州大学圣地亚哥分校初级感染队列数据库。这个合并后的数据库将称为临时秘书处数据库，将用于从三个来源获得临时秘书处所占百分比的初步估计数，以改进联合秘书处和大学联合委员会两个小组单独获得的估计数。此外，还将根据在合并这三个数据集时确定的质量控制和格式化程序，制定一项正式协议。该协议将提供关于如何对数据进行质量控制和格式化以纳入PTC数据库的具体说明。一旦我们确定了将数据集与估计PTC流行率所需的信息结合起来的可行性，并制定了一项关于如何准备数据集以纳入PTC数据库的协议，就计划推出R01应用程序，该应用程序将招募更多的站点向PTC数据库提供数据。将向每个站点提供该协议，以便它们能够有效和一致地准备各自的数据集，以便纳入PTC数据库。然后，该数据库将被用来估计PTC的流行率，并评估PTC的相关因素和其他机制。有关PTC的预测因素和其他特征的信息可能会允许某些具有这些预测因素和特征的患者考虑中断治疗。此外，确定与PTCS相关的因素可以指导寻找治疗HIV的功能性疗法的额外研究。