Evidence map›Paper›PMID 26372383›Full record

Trial reportAIDS (London, England)2015

A prospective, randomized clinical trial of antiretroviral therapies on carotid wall thickness.

James H Stein, Heather J Ribaudo, Howard N Hodis, Todd T Brown, Thuy Tien T Tran, Mingzhu Yan, Elizabeth Lauer Brodell, Theodore Kelesidis, Grace A McComsey, Michael P Dube and 2 more

Erratum issued Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in AIDS (London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00851799 (Cardiovascular, Anthropometric, and Skeletal Effects of Antiretroviral Therapy), which is not on this map. Cited by 45 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 1 pooled it
10.9field-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.

NCT00851799 completednot on this map

Cardiovascular, Anthropometric, and Skeletal Effects of Antiretroviral Therapy (ART) Initiation With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Plus Atazanavir/Ritonavir (ATV/r), Darunavir/Ritonavir (DRV/r), or Raltegravir (RAL): Metabolic Substudy of A5257

TypeobservationalSponsorAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsRan2009 to 2013Enrolled334ConditionsHIV InfectionArmsEmtricitabine/tenofovir disoproxil fumarate, Ritonavir, Atazanavir, Raltegravir, Darunavir
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 1 synthesis or guideline pooled it, 75 citations in OpenAlex.

  1. Pooled it
  2. Adipokines, Weight Gain and Metabolic and Inflammatory Markers After Antiretroviral Therapy Initiation: AIDS Clinical Trials Group (ACTG) A5260s.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Body Composition Changes After Initiation of Raltegravir or Protease Inhibitors: ACTG A5260s.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016
    Trial
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. HIV Associated Risk Factors for Ischemic Stroke and Future Perspectives.International journal of molecular sciences · 2020
    Review
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

12 authors at 7 institutions in 1 country.

James H SteinaUniversity of Wisconsin School of Medicine and Public Health, Madison, Wisconsin bHarvard School of Public Health, Boston, Massachusetts cKeck School of Medicine, University of Southern California, Los Angeles, California dJohns Hopkins University School of Medicine, Baltimore, Maryland eCase School of Medicine, Cleveland, Ohio fFeinberg School of Medicine, Northwestern University, Chicago, Illinois gDavid Geffen School of Medicine, University of California-Los Angeles, Los Angeles, California, USA.
Heather J Ribaudo
Howard N Hodis
Todd T Brown
Thuy Tien T Tran
Mingzhu Yan
Elizabeth Lauer Brodell
Theodore Kelesidis
Grace A McComsey
Michael P Dube
Robert L Murphy
Judith S Currier
University of Southern California · USHarvard University · USUniversity of California, Los Angeles · USUniversity of Wisconsin–Madison · USJohns Hopkins Medicine · USNorthwestern University · USUniversity Hospitals Case Medical Center · US

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
Statistical and Data Management Center for the AIDS Clinical Trials GroupU01AI068634 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI HUGHES, MICHAEL DAVID · 2006 to 2010
$71.9M
UCLA AIDS Prevention and Treatment Clinical Trials UnitUM1AI069424 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Judith S. Currier, RAPHAEL J LANDOVITZ · 2012 to 2026
$51.8M
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitUM1AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TIMOTHY J. WILKIN · 2012 to 2026
$50.4M
Virology CoreP30AI028697 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ZACK, JEROME A. · 1991 to 2018
$39.9M
Prospective Evaluation of Antiviral Therapy and Cardiac HealthR01HL095132 · NHLBI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI CURRIER, JUDITH S., STEIN, JAMES H · 2008 to 2012
$4.0M
Optimizing Antiretroviral Therapy in HIV K24AI056933 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI CURRIER, JUDITH S. · 2003 to 2013
$1.4M
Siemens S2000 Cardiovascular Ultrasound SystemS10OD010569 · OD · UNIVERSITY OF WISCONSIN-MADISON · PI STEIN, JAMES H · 2013 to 2013
$162k
NHLBI NIH HHS R01 HL095132NIAID NIH HHS K24 AI056933NIAID NIH HHS P30 AI028697NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI106701NIH HHS S10 OD010569
6 · The paper itself

Abstract

objectiveThis article compares the effects of initiating three contemporary antiretroviral therapy (ART) regimens on progression of carotid artery intima-media thickness (IMT) over 3 years.

designRandomized clinical trial.

settingMulticenter (26 institutions). PATIENTS: ART-naive HIV-infected individuals (n = 328) without known cardiovascular disease or diabetes mellitus.

interventionRandom assignment to tenofovir/emtricitabine along with atazanavir/ritonavir (ATV/r), darunavir/ritonavir (DRV/r), or raltegravir (RAL).

main outcome measuresRight-sided carotid IMT was evaluated by B-mode ultrasonography before ART initiation, and then after 48, 96, and 144 weeks. Comparisons of yearly rates of change in carotid IMT used mixed-effects linear regression models that permitted not only evaluation of the effects of ART on carotid IMT progression but also how ART-associated changes in traditional risk factors, bilirubin, and markers of HIV infection were associated carotid IMT progression.

resultsHIV-1 RNA suppression rates were high in all arms (>85%) over 144 weeks. Modest increases in triglycerides and non-high-density lipoprotein cholesterol levels were observed in the protease inhibitor-containing arms compared with decreases with RAL. In contrast, carotid IMT progressed more slowly on ATV/r [8.2, 95% confidence interval (5.6, 10.8) μm/year] than DRV/r [12.9 (10.3, 15.5) μm/year, P = 0.013]; changes with RAL were intermediate [10.7 (9.2, 12.2) μm/year, P = 0.15 vs. ATV/r; P = 0.31 vs. DRV/r]. Bilirubin and non-high-density lipoprotein cholesterol levels appeared to influence carotid IMT progression rates.

conclusionIn ART-naive HIV-infected individuals at low cardiovascular disease risk, carotid IMT progressed more slowly in participants initiating ATV/r than those initiating DRV/r, with intermediate changes associated with RAL. This effect may be due, in part, to hyperbilirubinemia.

Indexed as

Carotid Intima-Media ThicknessAdultAnti-Retroviral AgentsAntiretroviral Therapy, Highly ActiveCarotid ArteriesCarotid Artery DiseasesFemaleHIV-1HIV InfectionsHumansLongitudinal StudiesMaleMiddle AgedProspective StudiesAnti-Retroviral Agents

Identifiers

PMID26372383
PMCPMC4571277
OpenAlexW2415979752

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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 OpenQuestion graph.