Early intervention with 3BNC117 and romidepsin at antiretroviral treatment initiation in people with HIV-1: a phase 1b/2a, randomized trial.


Journal

Nature medicine
ISSN: 1546-170X
Titre abrégé: Nat Med
Pays: United States
ID NLM: 9502015

Informations de publication

Date de publication:
11 2022
Historique:
received: 15 03 2022
accepted: 22 08 2022
pubmed: 18 10 2022
medline: 22 11 2022
entrez: 17 10 2022
Statut: ppublish

Résumé

Attempts to reduce the human immunodeficiency virus type 1 (HIV-1) reservoir and induce antiretroviral therapy (ART)-free virologic control have largely been unsuccessful. In this phase 1b/2a, open-label, randomized controlled trial using a four-group factorial design, we investigated whether early intervention in newly diagnosed people with HIV-1 with a monoclonal anti-HIV-1 antibody with a CD4-binding site, 3BNC117, followed by a histone deacetylase inhibitor, romidepsin, shortly after ART initiation altered the course of HIV-1 infection ( NCT03041012 ). The trial was undertaken in five hospitals in Denmark and two hospitals in the United Kingdom. The coprimary endpoints were analysis of initial virus decay kinetics and changes in the frequency of CD4

Identifiants

pubmed: 36253609
doi: 10.1038/s41591-022-02023-7
pii: 10.1038/s41591-022-02023-7
pmc: PMC10189540
mid: NIHMS1880982
doi:

Substances chimiques

Anti-Retroviral Agents 0
Depsipeptides 0
romidepsin CX3T89XQBK

Banques de données

ClinicalTrials.gov
['NCT03041012']

Types de publication

Clinical Trial, Phase I Clinical Trial, Phase II Journal Article Randomized Controlled Trial Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

2424-2435

Subventions

Organisme : Medical Research Council
ID : MR/L00528X/1
Pays : United Kingdom
Organisme : NIAID NIH HHS
ID : P01 AI100148
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI164565
Pays : United States
Organisme : CIHR
Pays : Canada

Informations de copyright

© 2022. The Author(s), under exclusive licence to Springer Nature America, Inc.

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Auteurs

Jesper D Gunst (JD)

Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark.

Marie H Pahus (MH)

Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark.

Miriam Rosás-Umbert (M)

Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark.

I-Na Lu (IN)

Department of Neurology with Institute of Translational Neurology, University Hospital Münster, Münster, Germany.

Thomas Benfield (T)

Department of Infectious Diseases, Copenhagen University Hospital-Amager and Hvidovre, Hvidovre, Denmark.

Henrik Nielsen (H)

Department of Infectious Diseases, Aalborg University Hospital, Aalborg, Denmark.
Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.

Isik S Johansen (IS)

Department of Infectious Diseases, Odense University Hospital, University of Southern Denmark, Odense, Denmark.

Rajesh Mohey (R)

Department of Internal Medicine, Regional Hospital Herning, Herning, Denmark.

Lars Østergaard (L)

Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark.

Vibeke Klastrup (V)

Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark.

Maryam Khan (M)

Department of Infectious Diseases, Imperial College Hospital, London, UK.
The National Institute for Health Research, Imperial Biomedical Research Centre, London, UK.

Mariane H Schleimann (MH)

Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark.

Rikke Olesen (R)

Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark.

Henrik Støvring (H)

Department of Public Health, Aarhus University, Aarhus, Denmark.

Paul W Denton (PW)

Department of Biology, University of Nebraska at Omaha, Omaha, NE, USA.

Natalie N Kinloch (NN)

Faculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, Canada.
British Columbia Centre for Excellence in HIV/AIDS, Vancouver, British Columbia, Canada.

Dennis C Copertino (DC)

Infectious Diseases Division, Department of Medicine, Weill Cornell Medical College, New York, NY, USA.
Department of Microbiology and Immunology, Weill Cornell Graduate School of Medical Sciences, New York, NY, USA.

Adam R Ward (AR)

Infectious Diseases Division, Department of Medicine, Weill Cornell Medical College, New York, NY, USA.

Winiffer D Conce Alberto (WDC)

Infectious Diseases Division, Department of Medicine, Weill Cornell Medical College, New York, NY, USA.
Department of Microbiology and Immunology, Weill Cornell Graduate School of Medical Sciences, New York, NY, USA.

Silke D Nielsen (SD)

Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark.

Maria C Puertas (MC)

IrsiCaixa AIDS Research Institute, Badalona, Spain.
CIBERINFEC, Madrid, Spain.

Victor Ramos (V)

Laboratory of Molecular Immunology, The Rockefeller University, New York, NY, USA.

Jacqueline D Reeves (JD)

Labcorp-Monogram Biosciences, South San Francisco, CA, USA.

Christos J Petropoulos (CJ)

Labcorp-Monogram Biosciences, South San Francisco, CA, USA.

Javier Martinez-Picado (J)

IrsiCaixa AIDS Research Institute, Badalona, Spain.
CIBERINFEC, Madrid, Spain.
University of Vic-Central University of Catalonia, Vic, Spain.
Catalan Institution for Research and Advanced Studies, Barcelona, Spain.

Zabrina L Brumme (ZL)

Faculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, Canada.
British Columbia Centre for Excellence in HIV/AIDS, Vancouver, British Columbia, Canada.

R Brad Jones (RB)

Infectious Diseases Division, Department of Medicine, Weill Cornell Medical College, New York, NY, USA.
Department of Microbiology and Immunology, Weill Cornell Graduate School of Medical Sciences, New York, NY, USA.

Julie Fox (J)

Department of Genitourinary Medicine and Infectious Disease, Guy's and St Thomas' National Health Service Trust, London, UK.
Department of Genitourinary Medicine and Infectious Disease, The National Institute for Health Research Biomedical Research Centre, King's College London, London, UK.

Martin Tolstrup (M)

Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark.

Michel C Nussenzweig (MC)

Laboratory of Molecular Immunology, The Rockefeller University, New York, NY, USA.
Howard Hughes Medical Institute, The Rockefeller University, New York, NY, USA.

Marina Caskey (M)

Laboratory of Molecular Immunology, The Rockefeller University, New York, NY, USA.

Sarah Fidler (S)

Department of Infectious Diseases, Imperial College Hospital, London, UK.
The National Institute for Health Research, Imperial Biomedical Research Centre, London, UK.

Ole S Søgaard (OS)

Department of Clinical Medicine, Aarhus University, Aarhus, Denmark. olesoega@rm.dk.
Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark. olesoega@rm.dk.

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