Evidence map›Paper›PMID 41591761›Full record

ArticleClinical and translational science2026

Enhanced Clearance of HIV-1 Broadly Neutralizing Antibody VRC07-523-LS During Viremia: Influences on Trial Design and Analysis.

Nicholas M Smith, Brian M Ho, Katharine J Bar, Lucio Gama, Gabrielle Dziubla, Richard A Koup, Michael Pensiero, Leonid Serebryannyy, Marina Caskey, Timothy J Wilkin and 5 more

Erratum issuedAbstract read
In one paragraph

Article in Clinical and translational science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

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

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

Nicholas M SmithDivision of Clinical and Translational Therapeutics, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, The State University of New York, Buffalo, New York, USA.ORCID 0000-0002-0212-2787
Brian M HoDivision of Clinical and Translational Therapeutics, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, The State University of New York, Buffalo, New York, USA.ORCID 0009-0006-9229-4131
Katharine J BarDepartment of Infectious Diseases, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.ORCID 0000-0002-9773-0071
Lucio GamaVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Gabrielle DziublaVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.ORCID 0009-0009-4217-4854
Richard A KoupVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.ORCID 0000-0002-3090-7282
Michael PensieroDivision of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland, USA.
Leonid SerebryannyyVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.ORCID 0000-0003-0213-1779
Marina CaskeyLaboratory of Molecular Immunology, The Rockefeller University, New York, New York, USA.ORCID 0000-0003-1727-8693
Timothy J WilkinUniversity of California, San Diego, La Jolla, California, USA.ORCID 0000-0001-9386-9335
Troy D WoodDepartment of Chemistry, College of Arts and Sciences, University at Buffalo, The State University of New York, Buffalo, New York, USA.
Gene D MorseDivision of Clinical and Translational Therapeutics, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, The State University of New York, Buffalo, New York, USA.ORCID 0000-0001-6758-0941
Charles S VenutoDepartment of Neurology, Center for Health and Technology, University of Rochester, Rochester, New York, USA.ORCID 0000-0002-2394-9513
Ray ChaDivision of Clinical and Translational Therapeutics, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, The State University of New York, Buffalo, New York, USA.ORCID 0000-0001-6302-3881
Qing MaDivision of Clinical and Translational Therapeutics, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, The State University of New York, Buffalo, New York, USA.

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitUM1AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TIMOTHY J. WILKIN · 2012 to 2026
$50.4M
Weill Cornell Medicine - Rutgers New Jersey Medical School Clinical Trials UnitUM1AI069419 · NIAID · WEILL MEDICAL COLL OF CORNELL UNIV · PI ROY M. GULICK · 2012 to 2026
$44.6M
Pharmacokinetics and Pharmacodynamics of Mechanistically Aware Phage CocktailsR01AI177997 · NIAID · STATE UNIVERSITY OF NEW YORK AT BUFFALO · PI Nicholas Michael Smith · 2024 to 2026
$2.2M
NIAID NIH HHS R01 AI177997NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069419NIAID NIH HHS UM1 AI069432
6 · The paper itself

Abstract

Broadly neutralizing antibodies (BNAb) are capable of neutralizing multiple HIV-1 strains through the targeting of conserved epitopes. This study's objective was to quantify the pharmacokinetic (PK) parameters describing the distribution and elimination of the BNAb VRC07-523-LS in people with HIV (PWH), and to identify the influence of viral load on VRC07-523-LS elimination. The PK of VRC07-523-LS was assessed in participants with and without HIV after intravenous or subcutaneous administration. A Bayesian strategy was utilized to estimate VRC07-523-LS PK parameters, leveraging a previously published study in adults without HIV. The effects of static viral loads on VRC07-523-LS exposure and time to a target trough serum concentration of 1 mg/L was then evaluated using clinical trial simulations. VRC07-523-LS serum concentrations were described by a two-compartment model with first order absorption from the subcutaneous site. Typical clearance was estimated as 99.3 mL/day, which increased to a maximum of 6.46-fold higher with viremia. Clinical trial simulations without viremia showed that a 700-2100 mg dose of VRC07-523-LS is expected to remain above the IC

Indexed as

Antibodies, NeutralizingBroadly Neutralizing AntibodiesHIV-1HIV AntibodiesHIV InfectionsViremiaAdministration, IntravenousAdultBayes TheoremFemaleHumansInjections, SubcutaneousMaleMiddle AgedResearch DesignViral LoadAntibodies, NeutralizingBroadly Neutralizing AntibodiesHIV Antibodiesadaptive clinical trialBayesianbroadly neutralizing monoclonal antibodiesgenetic algorithmHIV‐1machine learningmonoclonal antibodypopulation pharmacokinetics

Identifiers

PMID41591761
PMCPMC12840558

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.