Evidence map›Paper›PMID 25214516›Full record

Trial reportThe Journal of infectious diseases2015

Rifaximin has a marginal impact on microbial translocation, T-cell activation and inflammation in HIV-positive immune non-responders to antiretroviral therapy - ACTG A5286.

Allan R Tenorio, Ellen S Chan, Ronald J Bosch, Bernard J C Macatangay, Sarah W Read, Suria Yesmin, Babafemi Taiwo, David M Margolis, Jeffrey M Jacobson, Alan L Landay and 2 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01466595 (A Pilot Study of Rifaximin as a Modulator of Gut Microbial Translocation and Systemic Immune Activation in HIV-Infected Individuals With Incomplete CD4+ T-cell Recovery on Antiretroviral Therapy), which is not on this map. Cited by 44 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 1 pooled it
4.3field-weighted citation impact, top 5% 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.

NCT01466595 phase2completednot on this map

A Pilot Study of Rifaximin as a Modulator of Gut Microbial Translocation and Systemic Immune Activation in HIV-Infected Individuals With Incomplete CD4+ T-cell Recovery on Antiretroviral Therapy

TypeinterventionalSponsorAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsRan2011 to 2012Enrolled73ConditionsHIV-1 InfectionArmsRifaximin
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 1 synthesis or guideline pooled it, 78 citations in OpenAlex.

  1. Adjunct Therapy for CD4Frontiers in immunology · 2021
    Pooled it
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  17. The Potential ofCells · 2022
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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

12 authors at 9 institutions in 2 countries.

Allan R TenorioDepartment of Medicine.
Ellen S ChanCenter for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts.
Ronald J BoschCenter for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts.
Bernard J C MacatangayDivision of Infectious Diseases, University of Pittsburgh School of Medicine.
Sarah W ReadHIV Research Branch, TRP, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institute of Health, Bethesda.
Suria YesminACTG Operations Center, Social and Scientific Systems, Silver Spring, Maryland.
Babafemi TaiwoFeinberg School of Medicine, Northwestern University, Chicago, Illinois.
David M MargolisDepartment of Medicine, University of North Carolina, Chapel Hill.
Jeffrey M JacobsonDivision of Infectious Diseases and HIV, Drexel University, Philadelphia, Pennsylvania.
Alan L LandayDepartment of Immunology and Microbiology, Rush University Medical Center.
Cara C WilsonDepartment of Medicine, University of Colorado at Denver, Aurora.
A5286 Team
Cancer Research And Biostatistics · USDrexel University · USNational Institute of Infectious Diseases · JPNorthwestern University · USRush University Medical Center · USSocial and Scientific Systems (United States) · USUniversity of Colorado Denver · USUniversity of North Carolina at Chapel Hill · USUniversity of Pittsburgh · 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
Virus & Reservoirs CoreP30AI045008 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI DAVID S METZGER · 1999 to 2026
$78.6M
Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
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
University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit 2024 SupplementUM1AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, MINA CHRISTINE HOSSEINIPOUR · 2012 to 2026
$71.8M
Harvard Medical School Vaccine Clinical Trials UnitUM1AI069412 · NIAID · BRIGHAM AND WOMEN'S HOSPITAL · PI Lindsey Robert Baden, Daniel R. Kuritzkes · 2012 to 2026
$57.2M
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
Clinical and Translational Science Collaborative of ClevelandUL1TR000439 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI KONSTAN, MICHAEL W. · 2012 to 2016
$50.0M
NCATS NIH HHS TR000439NCATS NIH HHS TR001070NCATS NIH HHS TR001082NCATS NIH HHS TR001111NCATS NIH HHS UL1 TR000042NCATS NIH HHS UL1 TR000439NCATS NIH HHS UL1 TR000457NCATS NIH HHS UL1 TR001070NCATS NIH HHS UL1 TR001082NCATS NIH HHS UL1 TR001111NCRR NIH HHS RR024160NCRR NIH HHS UL1 RR024160NIAID NIH HHS AI045008NIAID NIH HHS AI068636NIAID NIH HHS AI069412NIAID NIH HHS AI069415NIAID NIH HHS AI069418NIAID NIH HHS AI069419NIAID NIH HHS AI069423NIAID NIH HHS AI069424NIAID NIH HHS AI069432NIAID NIH HHS AI069439NIAID NIH HHS AI069447NIAID NIH HHS AI069452NIAID NIH HHS AI069470NIAID NIH HHS AI069471NIAID NIH HHS AI069477NIAID NIH HHS AI069481NIAID NIH HHS AI069494NIAID NIH HHS AI069501NIAID NIH HHS AI069502NIAID NIH HHS AI069503NIAID NIH HHS AI069511-08NIAID NIH HHS AI069532NIAID NIH HHS AI069534NIAID NIH HHS AI069556NIAID NIH HHS AI073961NIAID NIH HHS AI50410NIAID NIH HHS P30 AI045008NIAID NIH HHS P30 AI050410NIAID NIH HHS P30 AI073961NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069412NIAID NIH HHS U01 AI069415NIAID NIH HHS U01 AI069418NIAID NIH HHS U01 AI069419NIAID NIH HHS U01 AI069423NIAID NIH HHS U01 AI069424NIAID NIH HHS U01 AI069432NIAID NIH HHS U01 AI069439NIAID NIH HHS U01 AI069447NIAID NIH HHS U01 AI069452NIAID NIH HHS U01 AI069470NIAID NIH HHS U01 AI069471NIAID NIH HHS U01 AI069477NIAID NIH HHS U01 AI069481NIAID NIH HHS U01 AI069494NIAID NIH HHS U01 AI069501NIAID NIH HHS U01 AI069502NIAID NIH HHS U01 AI069503NIAID NIH HHS U01 AI069511NIAID NIH HHS U01 AI069532NIAID NIH HHS U01 AI069534NIAID NIH HHS U01 AI069556NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI069415NIAID NIH HHS UM1 AI069418NIAID NIH HHS UM1 AI069419NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069439NIAID NIH HHS UM1 AI069447NIAID NIH HHS UM1 AI069452NIAID NIH HHS UM1 AI069470NIAID NIH HHS UM1 AI069471NIAID NIH HHS UM1 AI069477NIAID NIH HHS UM1 AI069481NIAID NIH HHS UM1 AI069494NIAID NIH HHS UM1 AI069501NIAID NIH HHS UM1 AI069502NIAID NIH HHS UM1 AI069503NIAID NIH HHS UM1 AI069511NIAID NIH HHS UM1 AI069532NIAID NIH HHS UM1 AI069534NIAID NIH HHS UM1 AI069556NIAID NIH HHS UM1 AI106701PHS HHS A1025439PHS HHS AL050404
6 · The paper itself

Abstract

backgroundRifaximin, a nonabsorbable antibiotic that decreases lipopolysaccharide (LPS) in cirrhotics, may decrease the elevated levels of microbial translocation, T-cell activation and inflammation in human immunodeficiency virus (HIV)-positive immune nonresponders to antiretroviral therapy (ART).

methodsHIV-positive adults receiving ART for ≥96 weeks with undetectable viremia for ≥48 weeks and CD4(+) T-cell counts <350 cells/mm(3) were randomized 2:1 to rifaximin versus no study treatment for 4 weeks. T-cell activation, LPS, and soluble CD14 were measured at baseline and at weeks 2, 4, and 8. Wilcoxon rank sum tests compared changes between arms.

resultsCompared with no study treatment (n = 22), rifaximin (n = 43) use was associated with a significant difference between study arms in the change from baseline to week 4 for CD8(+)T-cell activation (median change, 0.0% with rifaximin vs +0.6% with no treatment; P = .03). This difference was driven by an increase in the no-study-treatment arm because there was no significant change within the rifaximin arm. Similarly, although there were significant differences between study arms in change from baseline to week 2 for LPS and soluble CD14, there were no significant changes within the rifaximin arm.

conclusionsIn immune nonresponders to ART, rifaximin minimally affected microbial translocation and CD8(+)T-cell activation. Trial registration number. NCT01466595.

Indexed as

Bacterial TranslocationLymphocyte ActivationAdolescentAdultAgedAnti-Bacterial AgentsAntiretroviral Therapy, Highly ActiveCD8-Positive T-LymphocytesFemaleHIV InfectionsHumansInflammationLipopolysaccharide ReceptorsLipopolysaccharidesMaleMiddle AgedAnti-Bacterial AgentsLipopolysaccharide ReceptorsLipopolysaccharidesRifamycinsRifaximinHIVimmune activationimmune nonresponders to ARTinflammationmicrobial translocationrifaximin

Identifiers

PMID25214516
PMCPMC4334803
OpenAlexW2162654321

What OpenQuestion holds

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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.