Effects of HIV antiretroviral therapy on pulmonary function in a randomized trial

一项随机试验中 HIV 抗逆转录病毒治疗对肺功能的影响

基本信息

批准号：
9116007
负责人：
KEN M. KUNISAKI
金额：
$ 53.34万
依托单位：
UNIVERSITY OF MINNESOTA
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-07-20 至 2018-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9116007
关键词：
Address Adherence Affect Age Alveolar Anti-Retroviral Agents Biological CD4 Lymphocyte Count CD8B1 gene Cells Chronic Chronic Obstructive Airway Disease Chronic lung disease Clinical Conflict (Psychology)Country Cross-Sectional Studies Cytotoxic T-Lymphocytes Data Development Early treatment Education Enrollment Equilibrium Forced expiratory volume function Funding Future Genetic HIV Envelope Protein gp120 HIV Infections HIV-1 Health Health Status Immune Infection Inflammation International Intervention Trial Investigation Knowledge Lead Life Lung Lung Inflammation Lung diseases Modeling National Heart, Lung, and Blood Institute Observational Study Outcome Oxidative Stress Parents Participant Pathogenesis Patients Persons Population Proteins Pulmonary Function Test/Forced Expiratory Volume 1 Questionnaires RNA Randomized Randomized Controlled Trials Recurrence Reporting Respiratory Tract Infections Respiratory physiology Risk Risk Factors Site Smoke Smoker Smoking Smoking Status Socioeconomic Status Specimen Spirometry T-Lymphocyte Testing Time Treatment Protocols Work antiretroviral therapy design disorder risk experience follow-up genomic biomarker high risk metabolomics microbiota monocyte non-smoker pulmonary function randomized trial reconstitution repository respiratory respiratory health response treatment group treatment trial trial design

项目摘要

DESCRIPTION (provided by applicant): Data suggest that patients infected with human immunodeficiency virus-1 (HIV) experience chronic lung inflammation, rapid lung function decline, and an increased risk of chronic obstructive pulmonary disease (COPD). Although potent combination antiretroviral treatment (ART) appears to reduce lung inflammation, the effects of ART on the rate of lung function decline and other important clinical outcomes remain unknown. This study is designed to address this knowledge gap, while providing a better understanding of the mechanisms for the rapid lung function decline observed in patients with HIV infection. This study has randomized 1,026 participants from 80 sites and 20 countries in a Pulmonary Substudy within a large, international, randomized, controlled trial - the Strategic Timing of AntiRetroviral Treatment (START) trial-and the study plans to follow these participants until unblinding in December 2016. The parent START trial has randomized 4,688 HIV-infected persons who were naïve to antiretroviral treatment, with a CD4+ count >500 cells/mm3. Participants were randomized to either immediate initiation of potent ART or deferral of ART until the CD4+ count declines to <350 cells/mm3. Participants in the Pulmonary Substudy were enrolled prior to randomization, thus permitting an appropriately controlled experimental comparison of the effects of immediate vs. deferred ART treatment on pulmonary outcomes. START is the only ongoing multi-site randomized study comparing immediate vs. deferred ART, and the Pulmonary Substudy is among the few (and the largest) randomized intervention trials underway focused on HIV-associated lung disease. The extensive biological specimen repository, including genetic data and other data collected as part of the parent START protocol, will provide opportunities for multiple future investigations of biomarkers, genomics, metabolomics and other mechanistic work directed at understanding the development of COPD in patients infected with HIV. This study will advance understanding of the pathogenesis of rapid lung function decline and subsequent COPD in the presence of HIV infection.

描述（由适用提供）：数据表明，感染了人类免疫缺陷病毒-1（HIV）的患者经历了慢性肺部感染，快速肺功能下降以及慢性阻塞性肺疾病（COPD）的风险增加。尽管潜在的抗逆转录病毒治疗（ART）似乎减少了肺部感染，但ART对肺功能下降和其他重要临床结果的影响仍然未知。这项研究旨在解决这一知识差距，同时可以更好地了解HIV感染患者观察到的快速肺功能下降的机制。这项研究已将来自80个地点和20个国家 / 20个国家的1,026名参与者随机分配在一个大型，国际，随机，随机对照试验中的肺部质量，这是抗逆转录病毒治疗（Start）试验的战略时机（Start）试验，研究计划计划跟随这些参与者直到2016年12月进行，直到2016年12月进行临时。细胞/MM3。参与者被随机分配给潜在的艺术或艺术递延，直到CD4+计数下降到<350个细胞/mm3。在随机分析之前招募了肺部的参与者，从而可以对即时与延期ART治疗对肺部结果的影响进行适当控制的实验比较。 Start是比较直接与递延艺术的唯一正在进行的多站点随机研究，肺部的属性是少数（也是最大的）随机干预试验之一，该试验集中在与HIV相关的肺部疾病上。广泛的生物标本存储库，包括遗传数据和作为父级协议一部分收集的其他数据，将为生物标志物，基因组学，代谢组学和其他机械工作的多种投资提供机会，该投资旨在了解感染HIV患者的COPD的发展。这项研究将在HIV感染存在下提高对快速肺功能下降和随后COPD的发病机理的了解。