Evidence map›Paper›PMID 25904376›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2015

Changes in Inflammation and Immune Activation With Atazanavir-, Raltegravir-, Darunavir-Based Initial Antiviral Therapy: ACTG 5260s.

Theodoros Kelesidis, Thuy Tien T Tran, James H Stein, Todd T Brown, Carlee Moser, Heather J Ribaudo, Michael P Dube, Robert Murphy, Otto O Yang, Judith S Currier and 1 more

Erratum issued 2 registry-linked trialsOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 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 2 registered trials, which are not on this map. Cited by 81 papers.

0numbers the graph read from it
0cells of the map it votes in
81citing papers in PubMed
8.3field-weighted citation impact, top 2% 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.

NCT00811954 phase3completednot on this map

The ARDENT Study: Atazanavir, Raltegravir, or Darunavir With Emtricitabine/Tenofovir for Naive Treatment

TypeinterventionalSponsorAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsRan2009 to 2013Enrolled1,814ConditionsHIV InfectionArmsEmtricitabine/tenofovir disoproxil fumarate, Raltegravir, Darunavir, Ritonavir, Atazanavir
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

81 citing papers in PubMed, 115 citations in OpenAlex.

  1. Trial
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  4. 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
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  8. Lower Pretreatment Gut Integrity Is Independently Associated With Fat Gain on Antiretroviral Therapy.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019
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  15. 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
  16. Article
  17. Review
  18. Article
  19. Article
  20. Article

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 1 country.

Theodoros KelesidisDavid Geffen School of Medicine at the University of California, Los Angeles.
Thuy Tien T TranCenter for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.
James H SteinUniversity of Wisconsin School of Medicine and Public Health, Madison.
Todd T BrownJohns Hopkins University, Baltimore, Maryland.
Carlee MoserCenter for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.
Heather J RibaudoCenter for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.
Michael P DubeKeck School of Medicine at the University of Southern California, Los Angeles.
Robert MurphyNorthwestern University, Evanston, Illinois.
Otto O YangDavid Geffen School of Medicine at the University of California, Los Angeles.
Judith S CurrierDavid Geffen School of Medicine at the University of California, Los Angeles.
Grace A McComseyCase Western Reserve University School of Medicine, Cleveland, Ohio University Hospitals Case Medical Center, Cleveland, Ohio.
Cancer Research And Biostatistics · USUniversity of California, Los Angeles · USJohns Hopkins University · USNorthwestern University · USUniversity of Southern California · USUniversity of Wisconsin–Madison · USUniversity School · 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
Virology CoreP30AI028697 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI CUMBERLAND, WILLIAM GLEN · 1991 to 2018
$39.9M
Northwestern University Clinical Trial UnitUM1AI069471 · NIAID · NORTHWESTERN UNIVERSITY AT CHICAGO · PI Chad J Achenbach · 2012 to 2026
$24.6M
WOMEN'S HEALTH AGENDAU01AI025915 · NIAID · NORTHWESTERN UNIVERSITY AT CHICAGO · PI MURPHY, ROBERT L. · 1987 to 2006
$15.3M
Northwestern University Clinical Trial UnitU01AI069471 · NIAID · NORTHWESTERN UNIVERSITY AT CHICAGO · PI MURPHY, ROBERT LEO · 2007 to 2011
$12.0M
CVD and Metabolic Complications of HIV/AIDS Data Coordinating CenterR01HL095126 · NHLBI · UNIVERSITY OF WASHINGTON · PI KRONMAL, RICHARD A · 2008 to 2012
$5.9M
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
NHLBI NIH HHS HL095126NHLBI NIH HHS HL095132NHLBI NIH HHS R01 HL095126NHLBI NIH HHS R01 HL095132NIAID NIH HHS AI068634NIAID NIH HHS AI 068636NIAID NIH HHS AI56933NIAID NIH HHS AI69471NIAID NIH HHS K08 AI108272NIAID NIH HHS K24 AI056933NIAID NIH HHS K24 AI120834NIAID NIH HHS P30 AI028697NIAID NIH HHS U01 AI025915NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069471NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069471NIAID NIH HHS UM1 AI106701NIDA NIH HHS K23 DA026308
6 · The paper itself

Abstract

backgroundIt is unclear whether the integrase inhibitor raltegravir (RAL) reduces inflammation and immune activation compared with ritonavir-boosted protease inhibitors (PIs).

methodsIn a prospective, randomized, multicenter clinical trial that included 328 human immunodeficiency type 1 (HIV-1)-infected, treatment-naive participants were randomized to receive tenofovir disoproxil fumarate-emtricitabine (TDF/FTC) plus atazanavir/ritonavir (ATV/r), darunavir/ritonavir (DRV/r), or RAL. A total of 234 participants (71%) with HIV-1 RNA levels <50 copies/mL by week 24 were included. Plasma biomarkers of inflammation and coagulation that were analysed included high-sensitivity C-reactive protein, interleukin-6 (IL-6), GlycA, D-dimer, soluble CD14 (sCD14), sCD163, and sIL-2r; blood cellular markers included %CD38+DR+ of T-cell subsets and %CD14+CD16+ and%CD14(dim)CD16+ monocyte subsets. Changes from baseline were examined at earlier (24 or 48 weeks) and later (96 weeks) time points, with 95% confidence intervals on fold-change. Pairwise treatment groups were compared using Wilcoxon rank sum tests, with P values adjusted for false discovery rate control.

resultsChanges in biomarkers varied by regimen during the 96 weeks of follow-up as follows: hsCRP declined with ATV/r and RAL, IL-6 declined only with RAL, and GLycA decreased in all groups. D-dimer declined with ATV/r and DRV/r and was unchanged with RAL. Markers of T-cell activation and sCD163 (but not sCD14 and CD14-+CD16+) declined in all groups.

conclusionsDespite some differences in specific markers of inflammation and immune activation between the antiretroviral therapy (ART) regimens, we found no consistent evidence that the reduction of inflammation and immune activation with ART initiation was different between RAL and PI-based regimens. CLINICAL TRIALS REGISTRATION: NCT00811954 and NCT00851799.

Indexed as

AdultAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveAtazanavir SulfateBiomarkersDarunavirFemaleHIV InfectionsHumansInflammationLongitudinal StudiesMaleMiddle AgedProspective StudiesRaltegravir PotassiumTreatment OutcomeAnti-HIV AgentsAtazanavir SulfateBiomarkersDarunavirRaltegravir Potassiumhuman immunodeficiency virusimmune activationinflammationintegrase inhibitorsprotease inhibitors

Identifiers

PMID25904376
PMCPMC4542595
OpenAlexW2169264636

What OpenQuestion holds

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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 OpenQuestion graph.