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Principal Investigator: Michael Tse-Yin Lu
Organization: MASSACHUSETTS GENERAL HOSPITAL
Fiscal Year: 2024
Award: $1,195,255
Funding agency: National Heart Lung and Blood Institute
Project Summary/Abstract
This proposal will support the Data Coordinating Center (DCC) for the Randomized Trial to Prevent Vascular
Events in HIV Trial (REPRIEVE) Extension for up to two additional years, with an additional year for study
close-out. This additional time is necessary to collect the major adverse cardiovascular events (MACE)
required to ensure adequate power to address the primary aim of REPRIEVE, to determine the efficacy of
statins as a primary cardiovascular prevention strategy in HIV. Completion of the trial will protect the value of
the initial NIH investment and leverage existing REPRIEVE infrastructure, with its data analytical and oversight
structures. This DCC proposal is a companion to the REPRIEVE Clinical Coordinating Center (CCC) proposal.
REPRIEVE is a multicenter, randomized, placebo controlled, pragmatic trial investigating the efficacy of statins
for primary prevention of cardiovascular disease (CVD) events (primary endpoint) in 7,770 persons with HIV
(PWH) without known CVD and with low to moderate CVD risk as per the 2013 ACC/AHA Pooled Cohort
Equations, (referred to as ASCVD risk). To understand the biology of statin effects, 805 participants were co-
enrolled in an embedded mechanistic substudy that will determine the effects of statins on non-calcified plaque
volume and high risk plaque morphology using coronary computed tomographic angiography (CTA), as well as
on blood biomarkers of vascular inflammation and immune activation after 4 months and two years. Further, in
response to the global SARS-CoV-2 pandemic, REPRIEVE will address critical knowledge gaps regarding the
epidemiology of SARS-CoV-2 infection and COVID-related CVD complications among PWH, and determine
the protective statin effects for COVID disease across the globe.
In the proposed extension, the REPRIEVE DCC will continue to provide methodological and logistical support
for the collection, quality control, and analysis of data including rigorous, timely, and independent adjudication
of potential MACE events. Furthermore, the DCC remains responsible for statistical design and analysis,
assistance in protocol development, data management, CTA data acquisition and interpretation, biospecimen
analysis, and electronic communications.
Terms: <AACTG><ACTG><AIDS Virus><AIDS clinical trial group><Acquired Immune Deficiency Syndrome Virus><Acquired Immunodeficiency Syndrome Virus><Active Follow-up><Address><Ancillary Study><Angiogram><Angiography><Apoplexy><Assay><Authorization><Authorization documentation><Bioassay><Biological Assay><Biological Markers><Biology><Blood><Blood Reticuloendothelial System><Blood Vessels><Brain Vascular Accident><CAT scan><COVID crisis><COVID epidemic><COVID pandemic><COVID-19><COVID-19 affected><COVID-19 consequence><COVID-19 crisis><COVID-19 effect><COVID-19 epidemic><COVID-19 era><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 impact><COVID-19 impacted><COVID-19 infection><COVID-19 pandemic><COVID-19 period><COVID-19 public health crisis><COVID-19 virus infection><COVID-19 years><COVID19 infection><CT X Ray><CT Xray><CT imaging><CT scan><CV-19><CVD prevention><Cardiac artery><Cardiac infarction><Cardiovascular><Cardiovascular Body System><Cardiovascular Diseases><Cardiovascular Organ System><Cardiovascular system><Cerebral Stroke><Cerebrovascular Apoplexy><Cerebrovascular Stroke><Clinical><Clinical Data><Clinical Trials><Clinical Trials Data Monitoring Committees><Collaborations><Collection><Companions><Computed Tomography><Computers><Coronary CT Angiography><Coronary artery><Coronavirus Infectious Disease 2019><Data><Data Analyses><Data Analysis><Data Analytics><Data Banks><Data Collection><Data Coordinating Center><Data Coordination Center><Data Monitoring Committees><Data Reporting><Data and Safety Monitoring Boards><Databanks><Disease><Disorder><E-Mail><Electronic Mail><Email><Enrollment><Ensure><Epidemiology><Equation><Event><HIV><Heart Vascular><Heart artery><Human Immunodeficiency Viruses><Immune Cell Activation><Information Dissemination><Infrastructure><Investments><Knowledge><LAV-HTLV-III><Laboratories><Lead><Leadership><Letters><Lymphadenopathy-Associated Virus><Methodology><Morphology><Myocardial Infarct><Myocardial Infarction><NHLBI><NIH><National Heart, Lung, and Blood Institute><National Institutes of Health><Outcome><Participant><Pb element><Permission><Persons><Placebo Control><Preparation><Preventative strategy><Prevention strategy><Preventive strategy><Primary Prevention><Procedures><Process><Publications><Quality Control><Randomization trial><Randomized><Reporting><Research><Research Design><Risk><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 infection><SARS-CoV-2 pandemic><SARS-CoV2 infection><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><Safety Monitoring Boards><Scientific Publication><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 infection><Severe acute respiratory syndrome coronavirus 2 pandemic><Site><Specialty><Statistical Data Analyses><Statistical Data Analysis><Statistical Data Interpretation><Stroke><Structure><Study Type><System><Time><Tomodensitometry><Training><United States National Institutes of Health><Virus-HIV><X-Ray CAT Scan><X-Ray Computed Tomography><X-Ray Computerized Tomography><Xray CAT scan><Xray Computed Tomography><Xray computerized tomography><acquired immunodeficiency syndrome clinical trial group><active followup><adjudication><adjudicative process and procedure><angiographic imaging><archive data><archiving data><bio-markers><biologic marker><biomarker><brain attack><cardiac disease prevention><cardiac infarct><cardiovascular disease prevention><cardiovascular disease risk><cardiovascular disorder><cardiovascular disorder prevention><cardiovascular disorder risk><catscan><cerebral vascular accident><cerebrovascular accident><circulatory system><cohort><computed axial tomography><computed coronary angiography scanning><computer tomography><computerized axial tomography><computerized tomography><coronary CTA><coronary attack><coronary computed tomography angiography><coronary infarct><coronary infarction><coronavirus disease 2019><coronavirus disease 2019 consequence><coronavirus disease 2019 crisis><coronavirus disease 2019 effect><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 impact><coronavirus disease 2019 infection><coronavirus disease 2019 pandemic><coronavirus disease 2019 public health crisis><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease pandemic><coronavirus disease-19><coronavirus disease-19 global pandemic><coronavirus disease-19 impact><coronavirus disease-19 pandemic><coronavirus infectious disease-19><data acquisition><data acquisitions><data archive><data archives><data depository><data exchange><data interpretation><data management><data management and coordinating center><data management center><data repository><data representation><data representations><data set repository><data sharing><data transfer><data transmission><dataset repository><design><designing><determine efficacy><dissemination of results><efficacy analysis><efficacy assessment><efficacy determination><efficacy evaluation><efficacy examination><electronic communication><enroll><epidemiologic><epidemiological><evaluate efficacy><examine efficacy><follow up><follow-up><followed up><followup><heart attack><heart disease prevention><heart disorder prevention><heart infarct><heart infarction><heavy metal Pb><heavy metal lead><high risk><imaging study><immune activation><infected with COVID-19><infected with COVID19><infected with SARS-CoV-2><infected with SARS-CoV2><infected with coronavirus disease 2019><infected with severe acute respiratory syndrome coronavirus 2><inflammation marker><inflammatory marker><medical specialties><meeting><meetings><non-contrast CT><noncontrast CT><noncontrast computed tomography><placebo controlled><pragmatic effectiveness trial><pragmatic trial><preparations><prevent><prevent heart disease><preventing><primary end point><primary endpoint><protocol development><randomisation><randomization><randomized trial><randomly assigned><response><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><statistical analysis><stroke event><stroked><strokes><study design><tool><trial design><vascular><vascular inflammation>