Evidence map›Paper›PMID 33693561›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2022

Randomized Trial of Ruxolitinib in Antiretroviral-Treated Adults With Human Immunodeficiency Virus.

Vincent C Marconi, Carlee Moser, Christina Gavegnano, Steven G Deeks, Michael M Lederman, Edgar T Overton, Athe Tsibris, Peter W Hunt, Amy Kantor, Rafick-Pierre Sekaly and 9 more

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, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02475655 (A Randomized, Pilot Study of Ruxolitinib in Antiretroviral-Treated HIV-Infected Adults), which is not on this map. Cited by 53 papers.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed
6.0field-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.

NCT02475655 phase2completednot on this map

A Randomized, Pilot Study of Ruxolitinib in Antiretroviral-Treated HIV-Infected Adults

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2016 to 2018Enrolled60ConditionsHIV InfectionsArmsRuxolitinib
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 58 citations in OpenAlex.

  1. Trial
  2. Review
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  4. Review
  5. Tenofovir, Interferon Pathways, and Mucosal Immunity: Implications for People Living With HIV.American journal of reproductive immunology (New York, N.Y. : 1989) · 2026
    Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. The STAT Signaling Pathway in HIV-1 Infection: Roles and Dysregulation.International journal of molecular sciences · 2025
    Review
  11. Article
  12. Article
  13. Review
  14. Article
  15. Review
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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

19 authors at 9 institutions in 1 country.

Vincent C MarconiEmory University School of Medicine, Atlanta, Georgia, USA.
Carlee MoserHarvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.
Christina GavegnanoEmory University School of Medicine, Atlanta, Georgia, USA.
Steven G DeeksUniversity of California, San Francisco, San Francisco, California, USA.
Michael M LedermanCase Western Reserve University, Cleveland, Ohio, USA.
Edgar T OvertonUniversity of Alabama at Birmingham, Birmingham, Alabama, USA.
Athe TsibrisHarvard Medical School, Boston, Massachusetts, USA.
Peter W HuntUniversity of California, San Francisco, San Francisco, California, USA.
Amy KantorHarvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.
Rafick-Pierre SekalyCase Western Reserve University, Cleveland, Ohio, USA.
Randall TresslerNational Institutes of Health, Bethesda, Maryland, USA.
Charles FlexnerJohns Hopkins University, Baltimore, Maryland, USA.
Selwyn J HurwitzEmory University School of Medicine, Atlanta, Georgia, USA.
Daniela MoisiCase Western Reserve University, Cleveland, Ohio, USA.
Brian ClagettCase Western Reserve University, Cleveland, Ohio, USA.
William R HardinDuke University, Durham, North Carolina, USA.
Carlos Del RioEmory University School of Medicine, Atlanta, Georgia, USA.
Raymond F SchinaziEmory University School of Medicine, Atlanta, Georgia, USA.
Jeffrey J LennoxEmory University School of Medicine, Atlanta, Georgia, USA.
Emory University · USCase Western Reserve University · USHarvard University · USUniversity of California, San Francisco · USDuke University · USEmory and Henry College · USJohns Hopkins University · USNational Institutes of Health · USUniversity of Alabama at Birmingham · 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
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
Virology and Molecular Biomarkers CoreP30AI050409 · NIAID · EMORY UNIVERSITY · PI Ann M Chahroudi, Colleen F Kelley · 2002 to 2026
$74.0M
San Francisco Vaccine and Prevention UnitUM1AI069496 · NIAID · PUBLIC HEALTH FOUNDATION ENTERPRISES · PI Susan Buchbinder, Diane V Havlir · 2012 to 2026
$30.5M
Towards Suppression and Elimination of HIV in the CNSR01MH116695 · NIMH · EMORY UNIVERSITY · PI SCHINAZI, RAYMOND FELIX, TYOR, WILLIAM R · 2018 to 2022
$3.4M
Persistent Functional Immune Defects in Treated HIV InfectionK24AI145806 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI HUNT, PETER W · 2020 to 2024
$921k
NIAIDNIAID NIH HHS K24 AI145806NIAID NIH HHS P30 AI050409NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069496NIAID NIH HHS UM1 AI106701NIH HHS UM1 AI068634NIMH NIH HHS R01 MH116695
6 · The paper itself

Abstract

backgroundInflammation is associated with end-organ disease and mortality for people with human immunodeficiency virus (PWH). Ruxolitinib, a Jak 1/2 inhibitor, reduces systemic inflammation for individuals without human immunodeficiency virus (HIV) and HIV reservoir markers ex vivo. The goal of this trial was to determine safety and efficacy of ruxolitinib for PWH on antiretroviral therapy (ART).

methodsAIDS Clinical Trials Group (ACTG) A5336 was an open-label, multisite, randomized controlled trial (RCT). Participants were randomly assigned (2:1) using centralized software to ruxolitinib (10 mg twice daily) plus stable ART for 5 weeks vs ART alone, stratified by efavirenz use. Eligible participants were suppressed on ART for ≥2 years, without comorbidities, and had >350 CD4+ T cells/µL. Primary endpoints were premature discontinuation, safety events, and change in plasma interleukin 6 (IL-6). Secondary endpoints included other measures of inflammation/immune activation and HIV reservoir.

resultsSixty participants were enrolled from 16 May 2016 to 10 January 2018. Primary safety events occurred in 2.5% (1 participant) for ruxolitinib and 0% for controls (P = .67). Three participants (7.5%) prematurely discontinued ruxolitinib. By week 5, differences in IL-6 (mean fold change [FC], 0.93 vs 1.10; P = .18) and soluble CD14 (mean FC, 0.96 vs 1.08; relative FC, 0.96 [90% confidence interval {CI}, .90-1.02]) levels for ruxolitinib vs controls was observed. Ruxolitinib reduced CD4+ T cells expressing HLA-DR/CD38 (mean difference, -0.34% [90% CI, -.66% to -.12%]) and Bcl-2 (mean difference, -3.30% [90% CI, -4.72% to -1.87%]).

conclusionsIn this RCT of healthy, virologically suppressed PWH on ART, ruxolitinib was well-tolerated. Baseline IL-6 levels were normal and showed no significant reduction. Ruxolitinib significantly decreased markers of immune activation and cell survival. Future studies of Jak inhibitors should target PWH with residual inflammation despite suppressive ART. CLINICAL TRIALS REGISTRATION: NCT02475655.

Indexed as

HIV InfectionsPyrimidinesAdultHIVHumansNitrilesPyrazolesNitrilesPyrazolesPyrimidinesruxolitinibHIVimmune activationinflammationJak inhibitorsreservoir

Identifiers

PMID33693561
PMCPMC8752257
OpenAlexW3133584248

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.