Evidence map›Paper›PMID 42202839›Full record

Trial reportThe lancet. HIV2026

Time to HIV rebound after infusion of long-acting broadly neutralising antibodies 3BNC117-LS and 10-1074-LS and analytical treatment interruption (the RIO trial): a double-blind, randomised, placebo-controlled trial.

Ming J Lee, Louise-Rae Cherrill, Panagiota Zacharopoulou, Simon Collins, Marcilio Fumagalli, Emanuela Falaschetti, Mohammed Altaf, Timothy Tipoe, Piyumika Godakandaarachi, Julie Fox and 36 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The lancet. HIV, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04319367 (A Randomised Placebo Controlled Trial of ART Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

NCT04319367 phase2recruitingnot on this map

A Randomised Placebo Controlled Trial of ART Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs) vs ART Plus Placebo in Treated Primary or Early Stage HIV Infection on Viral Control Off ART

TypeinterventionalSponsorImperial College LondonRan2021 to 2027Enrolled72ConditionsHIV/AIDS and InfectionsArmsInvestigational Medicinal Product
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Early immune responses anticipate HIV rebound and precede viral control.bioRxiv : the preprint server for biology · 2026
    Article
  5. Article
  6. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

46 authors.

Ming J LeeDepartment of Infectious Disease, and Imperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, London, UK; Imperial College Healthcare NHS Trust, London, UK.
Louise-Rae CherrillDepartment of Infectious Disease, and Imperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, London, UK.
Panagiota ZacharopoulouNuffield Department of Medicine, University of Oxford, London, UK.
Simon CollinsHIV i-Base, London, UK.
Marcilio FumagalliThe Rockefeller University, New York, NY, USA.
Emanuela FalaschettiDepartment of Infectious Disease, and Imperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, London, UK.
Mohammed AltafNuffield Department of Medicine, University of Oxford, London, UK.
Timothy TipoeNuffield Department of Medicine, University of Oxford, London, UK; Department of Medicine and Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.
Piyumika GodakandaarachiGuy's and St Thomas' Hospital NHS Foundation Trust, London, UK.
Julie FoxGuy's and St Thomas' Hospital NHS Foundation Trust, London, UK.
Alison UrielManchester University NHS Foundation Trust, Manchester, UK.
Amanda ClarkeUniversity Hospitals Sussex NHS Foundation Trust and Brighton & Sussex Medical School, Brighton, UK.
Sabine Kinloch-de LoesRoyal Free London NHS Foundation Trust, London, UK; University College London, London, UK.
Sarah PettUniversity College London, London, UK; Central and North West London NHS Foundation Trust, London, UK.
Marta BoffitoChelsea and Westminster Hospital, London, UK.
Gary WhitlockChelsea and Westminster Hospital, London, UK.
Ole S SøgaardAarhus University and Aarhus University Hospital, Aarhus, Denmark.
Kyle RingQueen Mary University of London and Barts Health NHS Trust, London, UK.
Irvine MangawaManchester University NHS Foundation Trust, Manchester, UK.
Jesal GohilDepartment of Infectious Disease, and Imperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, London, UK; Imperial College Healthcare NHS Trust, London, UK.
Tamara ElliottDepartment of Infectious Disease, and Imperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, London, UK; Imperial College Healthcare NHS Trust, London, UK; National Institute for Health Research, Imperial Biomedical Research Centre, London, UK.
Henrik NielsenAalborg University and Aalborg University Hospital, Aalborg, Denmark.
Jesper Damsgaard GunstAarhus University and Aarhus University Hospital, Aarhus, Denmark.
Chloe OrkinQueen Mary University of London and Barts Health NHS Trust, London, UK.
Rebecca SutherlandWestern General Hospital, NHS Lothian Trust, Edinburgh, UK.
Lisa HamzahSt George's University Hospitals, NHS Foundation Trust, London, UK.
Paola CicconiNuffield Department of Medicine, University of Oxford, London, UK; Centre for Clinical Vaccinology and Tropical Medicine and the Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
Graham P TaylorDepartment of Infectious Disease, and Imperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, London, UK.
Jacquie UjetzDepartment of Infectious Disease, and Imperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, London, UK.
Ishrat JahanDepartment of Infectious Disease, and Imperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, London, UK.
Helen BrownNuffield Department of Medicine, University of Oxford, London, UK.
Nicola RobinsonNuffield Department of Medicine, University of Oxford, London, UK.
Stephen FletcherDepartment of Infectious Disease, and Imperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, London, UK.
Hanna BoxDepartment of Infectious Disease, and Imperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, London, UK; National Institute for Health Research, Imperial Biomedical Research Centre, London, UK.
Kelly E SeatonDuke University, Durham, NC, USA.
Georgia D TomarasDuke University, Durham, NC, USA.
Margaret E AckermanDartmouth College, Hanover, NH, USA.
Joshua A WeinerDartmouth College, Hanover, NH, USA.
Anna KaczynskaThe Rockefeller University, New York, NY, USA.
Cintia BittarThe Rockefeller University, New York, NY, USA.
Jill HorowitzThe Rockefeller University, New York, NY, USA.
Michel C NussenzweigThe Rockefeller University, New York, NY, USA; Howard Hughes Medical Institute, Chevy Chase, MD, USA.
Marina CaskeyThe Rockefeller University, New York, NY, USA.
John FraterNuffield Department of Medicine, University of Oxford, London, UK; National Institute for Health Research, Oxford Biomedical Research Centre, Oxford, UK.
Sarah FidlerDepartment of Infectious Disease, and Imperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, London, UK; Imperial College Healthcare NHS Trust, London, UK; National Institute for Health Research, Imperial Biomedical Research Centre, London, UK. Electronic address: s.fidler@imperial.ac.uk.
RIO Study Team

Funding

Protein Expression CoreP01AI081677 · NIAID · ROCKEFELLER UNIVERSITY · PI NUSSENZWEIG, MICHEL C · 2009 to 2013
$10.6M
NIAID NIH HHS P01 AI081677
6 · The paper itself

Abstract

backgroundHIV-specific broadly neutralising antibodies (bNAbs) can maintain viral control after interrupting antiretroviral therapy (ART). We investigated the duration and efficacy of Fc-engineered long-acting bNAbs (LS-bNAbs) in maintaining ART-free HIV control compared with placebo.

methodsRIO is a double-blind, randomised, placebo-controlled trial. Eligibile participants were adults age 18-60 years, initiated on ART in early-stage HIV infection, virally suppressed on ART, and had no evidence of viral insensitivity to 10-1074. Participants were randomly assigned (1:1) to receive two LS-bNAbs (3BNC117-LS and 10-1074-LS) in arm A or saline placebo in arm B; participants and study staff were masked to assignment. Eligible participants interrupted ART after receiving blinded intravenous infusions of either bNAbs or placebo. A second optional infusion was offered after 20 weeks for participants who remained virally suppressed without ART. The primary outcome was time to viral rebound 20 weeks after ART interruption, defined as either the first of six consecutive plasma HIV RNA measurements greater than 1000 copies per mL, or two measurements greater than 100 000 copies per mL. All randomly assigned participants were included in the analyses. This study is registered with ClinicalTrials.gov, NCT04319367.

findings68 participants were randomly assigned, 34 to each arm. By week 20, viral rebound had occurred in eight participants in arm A and 30 in arm B; 75% (95% CI 61-92) of participants in arm A did not have viral rebound, compared with 11% (4-29) of participants in arm B. Participants in arm A were 91% less likely to rebound than were those in arm B (hazard ratio 0·09; 95% CI 0·04-0·21, p<0·0001). There were 326 adverse events in arm A and 260 in arm B, including 19 treatment-related or procedure-related adverse events in arm A and 41 in arm B. Of nine serious adverse events, none were treatment-related. The most commonly reported treatment-related or procedure-related adverse events were fatigue, lethargy, or somnolence: 11 in arm A and nine in arm B. There were two severe adverse events (anal abscesses) possibly related to the study protocol, both in the placebo arm.

interpretationLong-acting bNAbs can sustain extended ART-free viral control in people treated during early-stage HIV and represent a promising step towards achieving ART-free HIV remission.

fundingGates Foundation.

Indexed as

Broadly Neutralizing AntibodiesHIV-1HIV AntibodiesHIV InfectionsAdolescentAdultAntibodies, Monoclonal, HumanizedAnti-HIV AgentsDouble-Blind MethodFemaleHumansMaleMiddle AgedTreatment InterruptionTreatment OutcomeViral Load3BNC117 antibodyAntibodies, Monoclonal, HumanizedAnti-HIV AgentsBroadly Neutralizing AntibodiesHIV Antibodies

Identifiers

PMID42202839

What OpenQuestion holds

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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.