Evidence map›Paper›PMID 39226296›Full record

Trial reportThe Journal of infectious diseases2025

In-depth Analysis of the HIV Reservoir Confirms Effectiveness and Safety of Dolutegravir/Lamivudine in a Phase 4 Randomized Controlled Switch Trial (RUMBA).

Marie-Angélique De Scheerder, Sophie Degroote, Mareva Delporte, Maja Kiselinova, Wim Trypsteen, Lara Vincke, Evelien De Smet, Bram Van Den Eeckhout, Loïc Schrooyen, Maxime Verschoore and 7 more

2 registry-linked trialsAbstract readRandomized Controlled TrialClinical Trial, Phase IV
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

NCT04553081 phase4recruitingnot on this map

Virological and Immunological Assessment in HIV Positive Participants on 2DR Versus 3DR in a Prospective Randomized Controlled Switch Trial

TypeinterventionalSponsorUniversity Hospital, GhentRan2020 to 2027Enrolled134ConditionsHIV-1-infectionArmsDual versus triple therapy in treatment of HIV-1 infection.
NCT07138144 phase4recruitingnot on this map

Efficacy, Safety, and Tolerability of Switching to a Two-Drug Regimen With DTG/3TC Compared to Maintaining a Three-Drug Regimen With BIC/FTC/TAF or DTG/3TC/ABC in Virologically Suppressed PeopLe Living With HIV After 24 and 48 Weeks of Follow-Up

TypeinterventionalSponsorJosé Antonio Mata MarínRan2025 to 2026Enrolled156ConditionsHIV InfectionsArmsStandard Medical Therapy, dual therapy
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. 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

17 authors.

Marie-Angélique De ScheerderDepartment of Internal Medicine, Ghent University Hospital, Ghent, Belgium.
Sophie DegrooteDepartment of Internal Medicine, Ghent University Hospital, Ghent, Belgium.
Mareva DelporteHIV Cure Research Center, Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.ORCID 0000-0002-4423-3012
Maja KiselinovaDepartment of Internal Medicine, Ghent University Hospital, Ghent, Belgium.ORCID 0000-0002-0683-6840
Wim TrypsteenHIV Cure Research Center, Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.ORCID 0000-0001-9066-4932
Lara VinckeDepartment of Internal Medicine, Ghent University Hospital, Ghent, Belgium.
Evelien De SmetHIV Cure Research Center, Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.
Bram Van Den EeckhoutHIV Cure Research Center, Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.ORCID 0000-0002-6729-8951
Loïc SchrooyenHIV Cure Research Center, Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.ORCID 0000-0002-6324-4307
Maxime VerschooreHIV Cure Research Center, Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.
Camilla MucciniDepartment of Infectious Diseases, Istituti di Ricovero e Cura a Carattere Scientifico San Raffaele Scientific Institute, Milan, Italy.ORCID 0000-0002-0900-5639
Sophie VanherrewegeDepartment of Internal Medicine, Ghent University Hospital, Ghent, Belgium.
Els CaluweDepartment of Internal Medicine, Ghent University Hospital, Ghent, Belgium.
Stefanie De BuyserBiostatistics Unit, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.ORCID 0000-0002-9584-5529
Sarah GerloHIV Cure Research Center, Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.ORCID 0000-0002-1628-6088
Evy BlommeHIV Cure Research Center, Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.ORCID 0000-0002-5079-0675
Linos VandekerckhoveDepartment of Internal Medicine, Ghent University Hospital, Ghent, Belgium.ORCID 0000-0002-8600-1631

Funding

ViiV Healthcare
6 · The paper itself

Abstract

backgroundReducing the number of active compounds for lifelong human immunodeficiency virus (HIV) treatment is of interest, especially to reduce potential long-term side effects. So far, available data assessing viral control support the robustness and safety of 2DR (2-drug regimen) antiretroviral therapy compared to 3DR. However, further in-depth investigations of the viral reservoirs are mandatory to guarantee long-term safety of these regimens regarding stable intact HIV-1 DNA copies, HIV-1 RNA transcripts, and sustained immunological control.

methodsThe RUMBA study is the first prospective randomized controlled trial evaluating the impact of switch from 3DR to 2DR on the viral reservoir. Participants on any stable second-generation integrase strand transfer inhibitor-based 3DR regimen with HIV-1 RNA < 50 copies/mL plasma for at least 3 months were randomized to switch to dolutegravir/lamivudine (DTG/3TC, n = 89) or to switch or stay on bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, n = 45). After 48 weeks, virological, immunological, and metabolic parameters were evaluated.

resultsWe did not observe a significant difference in change over time in the mean number of intact HIV-1 DNA copies/million CD4+ T cells with DTG/3TC compared to B/F/TAF. There was no evidence in this study that switching to DTG/3TC increased the active reservoir by HIV-1 transcription. No significant changes in proinflammatory cytokines or major immune cell subsets were observed. Changes in exhaustion and activation of specific cellular subsets were small and bidirectional. Metabolic outcomes are similar between the treatment regimens.

conclusionsThis study confirms the safety of DTG/3TC compared to B/F/TAF through viral control after in-depth investigations of the intact HIV-1 reservoir, HIV-1 transcription, and inflammatory markers. CLINICAL TRIALS REGISTRATION: NCT04553081.

Indexed as

Anti-HIV AgentsHeterocyclic Compounds, 3-RingHIV-1HIV InfectionsLamivudineAdultAmidesCD4-Positive T-LymphocytesDolutegravirEmtricitabineFemaleHumansMaleMiddle AgedOxazinesPiperazinesAmidesAnti-HIV AgentsbictegravirDolutegravirEmtricitabineHeterocyclic Compounds, 3-RingLamivudineOxazinesPiperazinesPyridonesRNA, ViralTenofovirdual ARTHIV-1 reservoirinflammationmetabolic healthswitch randomized controlled trial

Identifiers

PMID39226296
PMCPMC11793038

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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.