Evidence map›Paper›PMID 35544074›Full record

Trial reportThe Lancet. Microbe2022

Effect of 3BNC117 and romidepsin on the HIV-1 reservoir in people taking suppressive antiretroviral therapy (ROADMAP): a randomised, open-label, phase 2A trial.

Henning Gruell, Jesper D Gunst, Yehuda Z Cohen, Marie H Pahus, Jakob J Malin, Martin Platten, Katrina G Millard, Martin Tolstrup, R Brad Jones, Winnifer D Conce Alberto and 15 more

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Microbe, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 60 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 2 pooled it
5.2field-weighted citation impact, top 3% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

60 citing papers in PubMed, 2 syntheses or guidelines pooled it, 77 citations in OpenAlex.

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  18. Searching for a HIV-1 Cure.Theranostics · 2026
    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

25 authors at 9 institutions in 3 countries.

Henning GruellLaboratory of Experimental Immunology, Institute of Virology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany; Department I of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany; German Center for Infection Research (DZIF) Bonn-Cologne, Cologne, Germany.
Jesper D GunstDepartment of Clinical Medicine, Aarhus University, Aarhus, Denmark; Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark.
Yehuda Z CohenLaboratory of Molecular Immunology, The Rockefeller University, New York, NY, USA.
Marie H PahusDepartment of Clinical Medicine, Aarhus University, Aarhus, Denmark; Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark.
Jakob J MalinDepartment I of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.
Martin PlattenDepartment I of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany; Wisplinghoff Laboratories, Cologne, Germany.
Katrina G MillardLaboratory of Molecular Immunology, The Rockefeller University, New York, NY, USA.
Martin TolstrupDepartment of Clinical Medicine, Aarhus University, Aarhus, Denmark; Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark.
R Brad JonesDivision of Infectious Diseases, Department of Medicine, Weill Cornell Medicine, New York, NY, USA.
Winnifer D Conce AlbertoDivision of Infectious Diseases, Department of Medicine, Weill Cornell Medicine, New York, NY, USA.
Julio C C LorenziLaboratory of Molecular Immunology, The Rockefeller University, New York, NY, USA.
Thiago Y OliveiraLaboratory of Molecular Immunology, The Rockefeller University, New York, NY, USA.
Tim KümmerleDepartment I of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany; Praxis am Ebertplatz, Cologne, Germany.
Isabelle SuárezDepartment I of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany; German Center for Infection Research (DZIF) Bonn-Cologne, Cologne, Germany.
Cecilia Unson-O'BrienLaboratory of Molecular Immunology, The Rockefeller University, New York, NY, USA.
Lilian NogueiraLaboratory of Molecular Immunology, The Rockefeller University, New York, NY, USA.
Rikke OlesenDepartment of Clinical Medicine, Aarhus University, Aarhus, Denmark; Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark.
Lars ØstergaardDepartment of Clinical Medicine, Aarhus University, Aarhus, Denmark; Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark.
Henrik NielsenDepartment of Infectious Diseases, Aalborg University Hospital, Aalborg, Denmark.
Clara LehmannDepartment I of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany; German Center for Infection Research (DZIF) Bonn-Cologne, Cologne, Germany; Center for Molecular Medicine Cologne, University of Cologne, Cologne, Germany.
Michel C NussenzweigLaboratory of Molecular Immunology, The Rockefeller University, New York, NY, USA; Howard Hughes Medical Institute, The Rockefeller University, New York, NY, USA.
Gerd FätkenheuerDepartment I of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany; German Center for Infection Research (DZIF) Bonn-Cologne, Cologne, Germany.
Florian KleinLaboratory of Experimental Immunology, Institute of Virology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany; German Center for Infection Research (DZIF) Bonn-Cologne, Cologne, Germany; Center for Molecular Medicine Cologne, University of Cologne, Cologne, Germany.
Marina CaskeyLaboratory of Molecular Immunology, The Rockefeller University, New York, NY, USA.
Ole S SøgaardDepartment of Clinical Medicine, Aarhus University, Aarhus, Denmark; Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark. Electronic address: olesoega@rm.dk.
Rockefeller University · USUniversity Hospital Cologne · DEAarhus University · DKAarhus University Hospital · DKUniversity of Cologne · DECornell University · USAalborg University Hospital · DKGerman Center for Infection Research · DEHoward Hughes Medical Institute · US

Funding

REACH: Research Enterprise to Advance a Cure for HIVUM1AI164565 · NIAID · WEILL MEDICAL COLL OF CORNELL UNIV · PI Marina Caskey, R. Brad Jones · 2021 to 2026
$32.9M
NIAID NIH HHS UM1 AI164565
6 · The paper itself

Abstract

backgroundThe administration of broadly neutralising anti-HIV-1 antibodies before latency reversal could facilitate elimination of HIV-1-infected CD4 T cells. We tested this concept by combining the broadly neutralising antibody 3BNC117 in combination with the latency-reversing agent romidepsin in people with HIV-1 who were taking suppressive antiretroviral therapy (ART).

methodsWe did a randomised, open-label, phase 2A trial at three university hospital centres in Denmark, Germany, and the USA. Eligible participants were virologically suppressed adults aged 18-65 years who were infected with HIV-1 and on ART for at least 18 months, with plasma HIV-1 RNA concentrations of less than 50 copies per mL for at least 12 months, and a CD4 T-cell count of greater than 500 cells per μL. Participants were randomly assigned (1:1) to receive 3BNC117 plus romidepsin or romidepsin alone in two cycles. All participants received intravenous infusions of romidepsin (5 mg/m

findingsBetween March 20, 2017, and Aug 14, 2018, 22 people were enrolled and randomly assigned, 11 to the 3BNC117 plus romidepsin group and 11 to the romidepsin group. 19 participants completed both treatment cycles and the ATI: 11 in the 3BNC117 plus romidepsin group and 8 in the romidepsin group. The median time to viral rebound during ATI was 18 days (IQR 14-28) in the 3BNC117 plus romidepsin group and 28 days (21-35) in the romidepsin group B (p=0·0016). Although this difference was significant, prolongation of time to viral rebound was not clinically meaningful in either group. All participants in both groups reported adverse events, but overall the combination of 3BNC117 and romidepsin was safe. Two severe adverse events were observed in the romidepsin group during 48 weeks of follow-up, one of which-increased direct bilirubin-was judged to be related to treatment.

interpretationThe combination of 3BNC117 and romidepsin was safe but did not delay viral rebound during analytic treatment interruptions in individuals on long-term ART. The results of our trial could serve as a benchmark for further optimisation of HIV-1 curative strategies among people with HIV-1 who are taking suppressive ART.

fundingamfAR, German Center for Infection Research.

Indexed as

DepsipeptidesHIV-1HIV InfectionsHIV SeropositivityAdultHIV AntibodiesHumansViral LoadDepsipeptidesHIV Antibodiesromidepsin

Identifiers

PMID35544074
PMCPMC10293654
OpenAlexW4207008834

What OpenQuestion holds

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Registered trials

None linked

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.