Evidence mapPaperPMID 30928825Full record

ArticleAmerican heart journal2019

Rationale and design of the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE).

Steven K Grinspoon, Kathleen V Fitch, Edgar Turner Overton, Carl J Fichtenbaum, Markella V Zanni, Judith A Aberg, Carlos Malvestutto, Michael T Lu, Judith S Currier, Craig A Sponseller and 9 more

Registry-linked trialOpen access · greenAbstract readClinical Trial Protocol
In one paragraph

Article in American heart journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02344290. Cited by 91 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
91citing papers in PubMed, 2 pooled it
22.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02344290 phase3completed

Randomized Trial to Prevent Vascular Events in HIV - REPRIEVE

Ran2015Enrolled7,769Registered outcomes37Posted comparisons40ConditionsCardiovascular Diseases, HIVArmsPitavastatin, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

91 citing papers in PubMed, 2 syntheses or guidelines pooled it, 148 citations in OpenAlex.

  1. Pooled it
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  9. Pitavastatin Is Well-Tolerated With no Detrimental Effects on Physical Function.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025 · on this map
    Trial
  10. Trial
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  14. Pericoronary Adipose Tissue Density, Inflammation, and Subclinical Coronary Artery Disease Among People With HIV in the REPRIEVE Cohort.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023 · on this map
    Trial
  15. Pitavastatin to Prevent Cardiovascular Disease in HIV Infection.The New England journal of medicine · 2023 · on this map
    Trial
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  20. Geographical Differences in the Self-Reported Functional Impairment of People With Human Immunodeficiency Virus (HIV) and Associations With Cardiometabolic Risk.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022 · on this map
    Trial

31 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 11 institutions in 1 country.

Steven K GrinspoonMGH Program in Nutritional Metabolism and Harvard Medical School, Boston, MA. Electronic address: sgrinspoon@mgh.harvard.edu.
Kathleen V FitchMGH Program in Nutritional Metabolism and Harvard Medical School, Boston, MA.
Edgar Turner OvertonDivision of Infectious Diseases, University of Alabama at Birmingham School of Medicine, Birmingham, AL.
Carl J FichtenbaumDivision of Infectious Diseases, University of Cincinnati College of Medicine, Cincinnati, OH.
Markella V ZanniMGH Program in Nutritional Metabolism and Harvard Medical School, Boston, MA.
Judith A AbergDivision of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.
Carlos MalvestuttoDivision of Infectious Diseases, Ohio State University Wexner Medical Center, Columbus, OH.
Michael T LuCardiac MR PET CT Program and Department of Radiology, Massachusetts General Hospital, Boston, MA.
Judith S CurrierDavid Geffen School of Medicine at University of California Los Angeles, Division of Infectious Diseases, Los Angeles, CA.
Craig A SponsellerKowa Pharmaceuticals America, Inc., Montgomery, AL.
Myron WaclawiwNational Institutes of Health/National Heart, Lung, and Blood Institute, Bethesda, MD.
Beverly Alston-SmithDAIDS, NIAID, NIH, Bethesda, MD.
Katharine Cooper-ArnoldNational Institutes of Health/National Heart, Lung, and Blood Institute, Bethesda, MD.
Karin L KlingmanDAIDS, NIAID, NIH, Bethesda, MD.
Patrice Desvigne-NickensNational Institutes of Health/National Heart, Lung, and Blood Institute, Bethesda, MD.
Udo HoffmannCardiac MR PET CT Program and Department of Radiology, Massachusetts General Hospital, Boston, MA.
Heather J RibaudoCenter for Biostatistics in AIDS Research, Department of Biostatistics, Harvard TH Chan School of Public Health, Boston, MA.
Pamela S DouglasDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
REPRIEVE Investigators
Harvard University · USNational Institutes of Health · USMassachusetts General Hospital · USNational Heart Lung and Blood Institute · USCancer Research And Biostatistics · USDuke University · USIcahn School of Medicine at Mount Sinai · USThe Ohio State University Wexner Medical Center · USUniversity of Alabama at Birmingham · USUniversity of California, Los Angeles · USUniversity of Cincinnati Medical Center · US

Funding

AIDS Clinical Trials Group for Research on Therapeutics for HIV and Related InfectionsUM1AI068636 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · 2021 to 2025
$229.0M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · 2021 to 2025
$81.6M
UCLA AIDS Prevention and Treatment Clinical Trials UnitUM1AI069424 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · 2021 to 2025
$22.2M
Pitt-Ohio State Clinical Trials UnitUM1AI069494 · NIAID · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2021 to 2025
$13.1M
Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplicationUM1AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · 2021 to 2025
$10.9M
Clinical and Translational Science CenterUL1TR002384 · WEILL MEDICAL COLL OF CORNELL UNIV · 2025 to 2025
$9.8M
A-Z Clinical Trials UnitUM1AI069452 · NIAID · UNIVERSITY OF ALABAMA AT BIRMINGHAM · 2021 to 2025
$9.1M
ROLE OF DIETARY CONSTITUENTS ON GENE EXPRESSION IN INTESTINAL EPITHELIUMP30DK040561 · MASSACHUSETTS GENERAL HOSPITAL · 1994 to 2025
$6.0M
NCATS NIH HHS UL1 TR001102NCATS NIH HHS UL1 TR002384NHLBI NIH HHS U01 HL123336NHLBI NIH HHS U01 HL123339NIAID NIH HHS U01 AI069463NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069452NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI069494NIDDK NIH HHS P30 DK040561
6 · The paper itself

Abstract

backgroundCardiovascular disease (CVD) is more frequent among people with HIV (PWH) and may relate to traditional and nontraditional factors, including inflammation and immune activation. A critical need exists to develop effective strategies to prevent CVD in this population.

methodsThe Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) (A5332) is a prospective, randomized, placebo-controlled trial of a statin strategy for the primary prevention of major adverse cardiovascular events (MACE) in PWH with low to moderate traditional risk. At least 7,500 PWH, 40-75 years of age, on stable antiretroviral therapy, will be randomized to pitavastatin calcium (4 mg/d) or identical placebo and followed for up to 8 years. Participants are enrolled based on the 2013 American College of Cardiology (ACC)/American Heart Association (AHA) atherosclerotic cardiovascular disease (ASCVD) risk score and low-density lipoprotein cholesterol (LDL-C) level with a goal to identify a low- to moderate-risk population who might benefit from a pharmacologic CVD prevention strategy. Potential participants with a risk score ≤ 15% were eligible based on decreasing LDL-C thresholds for increasing risk score >7.5% (LDL-C <190 mg/dL for risk score <7.5%, LDL-C <160 mg/dL for risk score 7.6%-10%, and LDL-C<130 mg/dL for risk score 10.1%-15%). The primary objective is to determine effects on a composite end point of MACE. Formal and independent adjudication of clinical events will occur using standardized criteria. Key secondary end points include effects on MACE components, all-cause mortality, specified non-CVD events, AIDS and non-AIDS events, and safety.

resultsTo date, REPRIEVE has enrolled >7,500 participants at approximately 120 sites across 11 countries, generating a diverse and representative population of PWH to investigate the primary objective of the trial.

conclusionsREPRIEVE is the first trial investigating a primary CVD prevention strategy in PWH. REPRIEVE will inform the field of the efficacy and safety of a statin strategy among HIV-infected participants on antiretroviral therapy and provide critical information on CVD mechanisms and non-CVD events in PWH.

Indexed as

Cardiovascular DiseasesHIV InfectionsHydroxymethylglutaryl-CoA Reductase InhibitorsQuinolinesAdultAgedAnti-HIV AgentsCholesterol, LDLClinical Trials, Phase III as TopicDouble-Blind MethodFemaleHumansMaleMiddle AgedMulticenter Studies as TopicPrimary PreventionAnti-HIV AgentsCholesterol, LDLHydroxymethylglutaryl-CoA Reductase InhibitorspitavastatinQuinolines

Identifiers

PMID30928825
PMCPMC6535121
OpenAlexW2918271361

What Socratic holds

Texttitle and abstract
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.