Evidence mapPaperPMID 30535188Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2019

A Randomized, Double-blinded, Placebo-controlled Trial of Sitagliptin for Reducing Inflammation and Immune Activation in Treated and Suppressed Human Immunodeficiency Virus Infection.

Michael P Dubé, Ellen S Chan, Jordan E Lake, Brett Williams, Jennifer Kinslow, Alan Landay, Robert W Coombs, Michelle Floris-Moore, Heather J Ribaudo, Kevin E Yarasheski

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

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01426438 (Effect of HDL-Raising Therapies on Endothelial Function, Lipoproteins, and Inflammation in HIV-infected Subjects With Low HDL Cholesterol), which is not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
5.3field-weighted citation impact, top 4% 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.

NCT01426438 phase2completednot on this map

Effect of HDL-Raising Therapies on Endothelial Function, Lipoproteins, and Inflammation in HIV-infected Subjects With Low HDL Cholesterol: A Phase II Randomized Trial of Extended Release Niacin vs. Fenofibrate

TypeinterventionalSponsorAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsRan2011 to 2013Enrolled99ConditionsHIV-1 InfectionArmsNiacin, Aspirin, Fenofibrate
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

  1. Adjunct Therapy for CD4Frontiers in immunology · 2021
    Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Diabetes in People with HIV.Current diabetes reports · 2021
    Review
  12. DPP4 Inhibitors and COVID-19-Holy Grail or Another Dead End?Archivum immunologiae et therapiae experimentalis · 2021
    Review
  13. Article
  14. Review
  15. Inflammatory Phenotypes Predict Changes in Arterial Stiffness Following Antiretroviral Therapy Initiation.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2020
    Article
  16. Observational
  17. Article
  18. Review
  19. Article
  20. Article
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

10 authors at 7 institutions in 1 country.

Michael P DubéKeck School of Medicine, University of Southern California, Los Angeles.
Ellen S ChanHarvard T. H. Chan School of Public Health, Boston, Massachusetts.
Jordan E LakeUniversity of Texas Health Science Center, Houston.
Brett WilliamsRush University Medical Center, Chicago, Illinois.
Jennifer KinslowRush University Medical Center, Chicago, Illinois.
Alan LandayRush University Medical Center, Chicago, Illinois.
Robert W CoombsUniversity of Washington, Seattle.
Michelle Floris-MooreUniversity of North Carolina, Chapel Hill.
Heather J RibaudoHarvard T. H. Chan School of Public Health, Boston, Massachusetts.
Kevin E YarasheskiWashington University, St. Louis, Missouri.
Rush University Medical Center · USHarvard University · USSeattle University · USThe University of Texas Health Science Center at Houston · USUniversity of North Carolina at Chapel Hill · USUniversity of Southern California · USWashington University in St. Louis · 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
AIDS Clinical Trial Group Laboratory CenterUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · 2021 to 2025
$54.5M
University of North Carolina Global HIV Prevention and Treatment Clinical Trials UnitUM1AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · 2021 to 2025
$23.6M
UCLA AIDS Prevention and Treatment Clinical Trials UnitUM1AI069424 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · 2021 to 2025
$22.2M
Weill Cornell Medicine - Rutgers New Jersey Medical School Clinical Trials UnitUM1AI069419 · NIAID · WEILL MEDICAL COLL OF CORNELL UNIV · 2021 to 2025
$18.7M
UCSD Collaborative Clinical Trials UnitUM1AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · 2021 to 2025
$18.1M
University of Pennsylvania HIV Clinical Trials UnitUM1AI069534 · NIAID · UNIVERSITY OF PENNSYLVANIA · 2021 to 2025
$16.2M
Case Clinical Trials UnitUM1AI069501 · NIAID · CASE WESTERN RESERVE UNIVERSITY · 2021 to 2025
$13.2M
Vanderbilt HIV Clinical Trials Unit (CTU)UM1AI069439 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · 2021 to 2025
$13.2M
Pitt-Ohio State Clinical Trials UnitUM1AI069494 · NIAID · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2021 to 2025
$13.1M
WOMEN'S HEALTH AGENDAU01AI025868 · UNIVERSITY OF NORTH CAROLINA CHAPEL HILL · 1987 to 2005
$13.0M
NCATS NIH HHS UL1 TR000457NCATS NIH HHS UL1 TR001873NIAID NIH HHS P30 AI050410NIAID NIH HHS U01 AI025868NIAID NIH HHS U01 AI025924NIAID NIH HHS U01 AI069428NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069419NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069439NIAID NIH HHS UM1 AI069465NIAID NIH HHS UM1 AI069470NIAID NIH HHS UM1 AI069494NIAID NIH HHS UM1 AI069501NIAID NIH HHS UM1 AI069503NIAID NIH HHS UM1 AI069534NIAID NIH HHS UM1 AI106701NIDDK NIH HHS R01 DK049393NIDDK NIH HHS R56 DK049393NIGMS NIH HHS P41 GM103422
6 · The paper itself

Abstract

backgroundDipeptidyl peptidase-4 (DPP-4) inhibitors have pleotropic anti-inflammatory and immune regulatory effects in addition to glucoregulation. We evaluated inflammation and immune markers in suppressed human immunodeficiency virus (HIV) infection during treatment with the DPP-4 inhibitor sitagliptin.

methodsVirologically suppressed adults with HIV without diabetes on stable antiretroviral therapy (ART) with ≥100/μL CD4 cells were randomized to 16 weeks of sitagliptin 100 mg/day vs placebo in a multicenter trial. The primary endpoint was the change in plasma soluble CD14 (sCD14) from baseline to week 15-16.

resultsNinety participants were randomized, and 42 from each arm were included in per-protocol analyses. Participants were 45% non-Hispanic white, 38% non-Hispanic black, and 15% Hispanic, with a median age of 51 years; 83% were male; and the median CD4 count was 602 cells/μL. At week 15-16, there was no difference in sCD14 change between the 2 arms (P = .69). Relative to placebo, the sitagliptin arm had 47% greater decline in CXCL10 (95% confidence interval, -57% to -35%) at week 15 (P < .001). There were no significant between-arm differences in other soluble biomarkers, total CD4 and CD8 counts, or markers of lymphocyte or monocyte activation. Sitagliptin was well tolerated.

conclusionsSixteen weeks of sitagliptin had no effect on sCD14 levels in virologically suppressed participants with HIV. CXCL10, a chemokine involved in atherogenesis that predicts non-AIDS events during ART, declined markedly with sitagliptin. This suggests that DPP-4 inhibition has the potential to reduce cardiovascular morbidity in treated HIV infection. CLINICAL TRIALS REGISTRATION: NCT01426438.

Indexed as

AdultAnti-Inflammatory AgentsAntiretroviral Therapy, Highly ActiveBiomarkersCD4 Lymphocyte CountFemaleHIVHIV InfectionsHumansImmunologic FactorsMaleMiddle AgedSitagliptin PhosphateTreatment OutcomeViral LoadAnti-Inflammatory AgentsBiomarkersImmunologic FactorsSitagliptin PhosphateCXCL10dipeptidyl peptidase-4 inhibitorHIVinflammationsoluble CD14

Identifiers

PMID30535188
PMCPMC6743814
OpenAlexW2905051451

What Socratic holds

Textmetadata
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.