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Pitavastatin to REduce Physical Function Impairment and FRailty in HIV (PREPARE)

匹伐他汀可减少艾滋病毒导致的身体功能损伤和虚弱（PREPARE）

基本信息

批准号：
9204187
负责人：
Kristine Mace Erlandson
金额：
$ 62.47万
依托单位：
UNIVERSITY OF COLORADO DENVER
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-08-01 至 2021-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9204187
关键词：
AIDS clinical trial group Adult Affect Aging Anti-Inflammatory Agents Anti-inflammatory Atherosclerosis Attenuated Automobile Driving Biological Preservation Cardiovascular Diseases Cardiovascular system Caring Cessation of life Chronic Chronic Disease Clinical Trials Comorbidity Coronary Arteriosclerosis Critical Pathways Data Disease Elderly Employee Strikes Endocrinology Epidemiology Equipoise Event Fatty acid glycerol esters Funding General Population Geriatrics Goals Guidelines HIV HIV Infections Hospitalization Hydroxymethylglutaryl-CoA Reductase Inhibitors Image Impairment In Vitro Independent Living Infection Infiltration Inflammation Intervention LDL Cholesterol Lipoproteins Link Lipids Maintenance Measures Mediating Medicine Muscle Muscle function Oxidoreductase Participant Pathway interactions Persons Pharmaceutical Preparations Physical Function Placebos Population Prevention Property Radiology Specialty Randomized Randomized Clinical Trials Research Infrastructure Research Personnel Resources Risk Role Skeletal Muscle Testing United States National Institutes of Health Work X-Ray Computed Tomography age related aging population base cardiovascular disorder prevention coronary computed tomography angiography disability double-blind placebo controlled trial effective therapy fall risk falls frailty functional decline functional disability health related quality of life immune activation improved inflammatory marker inhibitor/antagonist insight mortality multidisciplinary novel osteoporosis with pathological fracture prevent skeletal statistics treatment strategy

项目摘要

The overall goals of this proposal are to determine whether the HMG-coA reductase inhibitor, pitavastatin, can attenuate the aging-related decline in physical function in older HIV-infected persons, and to identify the critical pathways underlying physical function impairment. Our previous work has demonstrated greater than expected impairments in physical function among older HIV-infected persons, with an increased risk of falls, hospitalizations, and mortality. The underlying mechanisms of impaired physical function among HIV-infected persons have not been elucidated, but our data strongly suggest an association with chronic inflammation. To test whether this link is casual, we will determine whether pitavastatin, an HMG-CoA reductase inhibitor with anti-inflammatory effects, will improve physical function, among older HIV-infected adults on effective ART who are at risk for frailty and its complications. Previous data regarding the effects of statins on physical function among populations without HIV have been mixed, with some studies showing a benefit and others showing harm or a null effect. In the setting of this state of true equipoise, we propose a randomized, double-blind, placebo-controlled trial of pitavastatin in HIV-infected adults without a statin indication to evaluate whether pitavastatin can prevent the decline of physical function over four years. We will also determine whether pitavastatin impacts key pathways thought to underlie physical function impairments, including elevated systemic inflammation and increased fatty infiltration of muscle. Our proposed study will leverage the resources of the AIDS Clinical Trials Group and the REPRIEVE trial, a large NIH-funded, randomized clinical trial evaluating the effects of pitavastatin on cardiovascular events. The following aims are proposed: 1) To determine the effects of pitavastatin on physical function, 2) To evaluate mechanistic pathways through which pitavastatin affects physical function. The results of our study will provide critical information regarding the potential benefit of statin therapy on physical function versus the potential harm of treatment and burden of an additional medication in an aging population. The study will also provide key insights into the longitudinal relationships between inflammation, muscle fat, and physical function. Importantly, the study will test a novel intervention to reduce functional impairments among aging HIV- infected persons.