Evidence map›Paper›PMID 38980725›Full record

Trial reportJCI insight2024

Vedolizumab and ART in recent HIV-1 infection unveil the role of α4β7 in reservoir size.

Maria Reyes Jimenez-Leon, Carmen Gasca-Capote, Cristina Roca-Oporto, Nuria Espinosa, Salvador Sobrino, Maria Fontillon-Alberdi, Ce Gao, Isabelle Roseto, Gregory Gladkov, Inmaculada Rivas-Jeremias and 20 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in JCI insight, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03577782 (Phase II Clinical Trial to Analyze the Safety and Efficacy of Vedolizumab Combined With Antiretroviral Therapy to Achieve Permanent Virological Remission in HIV-infected Subjects Without Previous Antiretroviral Therapy), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
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.

NCT03577782 phase1 / phase2unknown statusnot on this map

Phase II Clinical Trial to Analyze the Safety and Efficacy of Vedolizumab Combined With Antiretroviral Therapy to Achieve Permanent Virological Remission in HIV-infected Subjects Without Previous Antiretroviral Therapy

TypeinterventionalSponsorHospitales Universitarios Virgen del RocíoRan2018 to 2020Enrolled12ConditionsHIV InfectionsArmsEntyvio (Vedolizumab)
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Article
  2. Article
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  4. Review
  5. Review
  6. Article
  7. Review
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

30 authors.

Maria Reyes Jimenez-LeonInstitute of Biomedicine of Seville, Virgen del Rocío University Hospital, Consejo Superior de Investigaciones Científicas, University of Seville, Clinical Unit of Infectious Diseases, Microbiology and Parasitology, Seville, Spain.
Carmen Gasca-CapoteInstitute of Biomedicine of Seville, Virgen del Rocío University Hospital, Consejo Superior de Investigaciones Científicas, University of Seville, Clinical Unit of Infectious Diseases, Microbiology and Parasitology, Seville, Spain.
Cristina Roca-OportoInstitute of Biomedicine of Seville, Virgen del Rocío University Hospital, Consejo Superior de Investigaciones Científicas, University of Seville, Clinical Unit of Infectious Diseases, Microbiology and Parasitology, Seville, Spain.
Nuria EspinosaInstitute of Biomedicine of Seville, Virgen del Rocío University Hospital, Consejo Superior de Investigaciones Científicas, University of Seville, Clinical Unit of Infectious Diseases, Microbiology and Parasitology, Seville, Spain.
Salvador SobrinoDigestive Service and.
Maria Fontillon-AlberdiService of Pathological Anatomy, Virgen del Rocío University Hospital, Seville, Spain.
Ce GaoRagon Institute of MGH, MIT and Harvard, Cambridge, Massachusetts, USA.
Isabelle RosetoRagon Institute of MGH, MIT and Harvard, Cambridge, Massachusetts, USA.
Gregory GladkovRagon Institute of MGH, MIT and Harvard, Cambridge, Massachusetts, USA.
Inmaculada Rivas-JeremiasInstitute of Biomedicine of Seville, Virgen del Rocío University Hospital, Consejo Superior de Investigaciones Científicas, University of Seville, Clinical Unit of Infectious Diseases, Microbiology and Parasitology, Seville, Spain.
Karin NeukamInstitute of Biomedicine of Seville, Virgen del Rocío University Hospital, Consejo Superior de Investigaciones Científicas, University of Seville, Clinical Unit of Infectious Diseases, Microbiology and Parasitology, Seville, Spain.
Jose German Sanchez-HernandezPharmacy service, University Hospital of Salamanca-Institute for Biomedical Research of Salamanca, Salamanca, Spain.
Raul Rigo-BonninDepartment of Clinical Laboratory, Hospital Universitari de Bellvitge, Instituto de Investigación Biomédica de Bellvitge, Universitat de Barcelona, Barcelona, Spain.
Antonio J Cervera-BarajasClinical Trials Units, Virgen del Rocío University Hospital, Seville, Spain.
Rosario MesonesClinical Trials Units, Virgen del Rocío University Hospital, Seville, Spain.
Federico GarcíaDepartament of Microbiology, San Cecilio University Hospital, Instituto de Investigación Ibs, Granada, Ciber de Enfermedades Infecciosas, Centro de Investigación Biomédica en Red de Enfermedades Infecciosas, Granada, Spain.
Ana Isabel Alvarez-RiosBiochemistry Service, Virgen del Rocío University Hospital, Seville, Spain.
Sara BachillerInstitute of Biomedicine of Seville, Virgen del Rocío University Hospital, Consejo Superior de Investigaciones Científicas, University of Seville, Clinical Unit of Infectious Diseases, Microbiology and Parasitology, Seville, Spain.
Joana VitalleInstitute of Biomedicine of Seville, Virgen del Rocío University Hospital, Consejo Superior de Investigaciones Científicas, University of Seville, Clinical Unit of Infectious Diseases, Microbiology and Parasitology, Seville, Spain.
Alberto Perez-GomezInstitute of Biomedicine of Seville, Virgen del Rocío University Hospital, Consejo Superior de Investigaciones Científicas, University of Seville, Clinical Unit of Infectious Diseases, Microbiology and Parasitology, Seville, Spain.
María Inés Camacho-SojoInstitute of Biomedicine of Seville, Virgen del Rocío University Hospital, Consejo Superior de Investigaciones Científicas, University of Seville, Clinical Unit of Infectious Diseases, Microbiology and Parasitology, Seville, Spain.
Isabel GallegoInstitute of Biomedicine of Seville, Virgen del Rocío University Hospital, Consejo Superior de Investigaciones Científicas, University of Seville, Clinical Unit of Infectious Diseases, Microbiology and Parasitology, Seville, Spain.
Christian BranderAELIX Therapeutics S.L., Barcelona, Spain.
Ian McGowanAELIX Therapeutics S.L., Barcelona, Spain.
Beatriz MotheInfectious Diseases Department and IrsiCaixa AIDS Research Institute, Hospital Germans Trias I Pujol, Badalona, Spain.
Pompeyo VicianaInstitute of Biomedicine of Seville, Virgen del Rocío University Hospital, Consejo Superior de Investigaciones Científicas, University of Seville, Clinical Unit of Infectious Diseases, Microbiology and Parasitology, Seville, Spain.
Xu YuRagon Institute of MGH, MIT and Harvard, Cambridge, Massachusetts, USA.
Mathias LichterfeldRagon Institute of MGH, MIT and Harvard, Cambridge, Massachusetts, USA.
Luis F Lopez-CortesInstitute of Biomedicine of Seville, Virgen del Rocío University Hospital, Consejo Superior de Investigaciones Científicas, University of Seville, Clinical Unit of Infectious Diseases, Microbiology and Parasitology, Seville, Spain.
Ezequiel Ruiz-MateosInstitute of Biomedicine of Seville, Virgen del Rocío University Hospital, Consejo Superior de Investigaciones Científicas, University of Seville, Clinical Unit of Infectious Diseases, Microbiology and Parasitology, Seville, Spain.

Funding

Selection and Evolution of HIV-1 reservoir cells in blood and tissuesR01AI152979 · NIAID · BRIGHAM AND WOMEN'S HOSPITAL · PI ESTES, JACOB D, LICHTERFELD, MATHIAS · 2020 to 2025
$3.8M
Mentoring in patient-oriented research to finding a cure for HIV-1 infectionK24AI155233 · NIAID · BRIGHAM AND WOMEN'S HOSPITAL · PI LICHTERFELD, MATHIAS · 2021 to 2025
$958k
NIAID NIH HHS K24 AI155233NIAID NIH HHS R01 AI152979
6 · The paper itself

Abstract

BACKGROUNDWe evaluated the safety and viral rebound, after analytical treatment interruption (ATI), of vedolizumab and ART in recent HIV-1 infection. We used this model to analyze the effect of α4β7 on the HIV-1 reservoir size.METHODSParticipants started ART with monthly vedolizumab infusions, and ATI was performed at week 24. Biopsies were obtained from ileum and cecum at baseline and week 24. Vedolizumab levels, HIV-1 reservoir, flow cytometry, and cell-sorting and antibody competition experiments were assayed.RESULTSVedolizumab was safe and well tolerated. No participant achieved undetectable viremia off ART 24 weeks after ATI. Only a modest effect on the time to achieve more than 1,000 HIV-1 RNA copies/mL and the proportion of participants off ART was observed, being higher in the vedolizumab group compared with historical controls. Just before ATI, α4β7 expression was associated with HIV-1 DNA and RNA in peripheral blood and with PD1 and TIGIT levels. Importantly, a complete blocking of α4β7 was observed on peripheral CD4+ T cells but not in gut (ileum and cecum), where α4β7 blockade and vedolizumab levels were inversely associated with HIV-1 DNA.CONCLUSIONOur findings support α4β7 as an important determinant in HIV-1 reservoir size, suggesting the complete α4β7 blockade in tissue as a promising tool for HIV-cure combination strategies.TRIAL REGISTRATIONClinicalTrials.gov NCT03577782.FUNDINGThis work was supported by the Instituto de Salud Carlos III (Fondo Europeo de Desarrollo Regional, "a way to make Europe," research contracts FI17/00186 and FI19/00083 and research projects PI18/01532, PI19/01127, PI22/01796), Conserjería de Economía, Conocimiento, Empresas y Universidad, Junta de Andalucía (research projects P20/00906), the Red Temática de Investigación Cooperativa en SIDA (RD16/0025/0020), and the Spanish National Research Council.

Indexed as

Antibodies, Monoclonal, HumanizedHIV-1HIV InfectionsViral LoadAdultAnti-HIV AgentsCD4-Positive T-LymphocytesFemaleHumansIleumIntegrinsMaleMiddle AgedRNA, ViralAntibodies, Monoclonal, HumanizedAnti-HIV Agentsintegrin alpha4beta7IntegrinsRNA, ViralvedolizumabAIDS/HIVImmunologyImmunotherapy

Identifiers

PMID38980725
PMCPMC11343594

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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.