Evidence map›Paper›PMID 28431010›Full record

Trial reportThe Journal of infectious diseases2017

Clinical Trial of the Anti-PD-L1 Antibody BMS-936559 in HIV-1 Infected Participants on Suppressive Antiretroviral Therapy.

Cynthia L Gay, Ronald J Bosch, Justin Ritz, Jason M Hataye, Evgenia Aga, Randall L Tressler, Stephen W Mason, Carey K Hwang, Dennis M Grasela, Neelanjana Ray and 7 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2017. 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 151 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
151citing papers in PubMed, 2 pooled it
13.5field-weighted citation impact, top 1% 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.

NCT02028403 phase1completednot on this map

Safety, Pharmacokinetics and Immunotherapeutic Activity of an Anti-PD-L1 Antibody (BMS-936559) in HIV-1 Infected Participants on Suppressive cART: A Phase I, Double-Blind, Placebo-Controlled, Ascending Single Dose Study

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2014 to 2015Enrolled8ConditionsHIV InfectionsArmsBMS-936559, Placebo for BMS-936559
NCT03367754 phase1terminatednot on this mapstarted 2018, after this paper: background citation

A Randomized, Double-Blind, Placebo-Controlled Study of a Single Dose of Pembrolizumab in HIV-Infected Patients

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2018 to 2024Enrolled11ConditionsHuman Immunodeficiency VirusArmsPlacebo, Pembrolizumab
3 · Its place in the literature

Who cites it

151 citing papers in PubMed, 2 syntheses or guidelines pooled it, 220 citations in OpenAlex.

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  19. Nanocarrier-based immunotherapy for viral diseases.International journal of pharmaceutics: X · 2025
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91 more citing papers are in PubMed but not listed here.

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 at 8 institutions in 2 countries.

Cynthia L GayDepartment of Medicine, University of North Carolina at Chapel Hill.
Ronald J BoschDepartment of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.
Justin RitzDepartment of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.
Jason M HatayeImmunology Laboratory, Vaccine Research Center.
Evgenia AgaDepartment of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.
Randall L TresslerDivision of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland.
Stephen W MasonBristol-Myers Squibb, Wallingford, Connecticut.
Carey K HwangBristol-Myers Squibb, Princeton, New Jersey.
Dennis M GraselaBristol-Myers Squibb, Princeton, New Jersey.
Neelanjana RayBristol-Myers Squibb, Princeton, New Jersey.
Josh C CyktorDepartment of Medicine, University of Pittsburgh, Pennsylvania.
John M CoffinMolecular Biology and Microbiology, Tufts University School of Medicine, Boston, Massachusetts.
Edward P AcostaDepartment of Pharmacology and Toxicology, University of Alabama School of Medicine, Birmingham.
Richard A KoupImmunology Laboratory, Vaccine Research Center.
John W MellorsDepartment of Medicine, University of Pittsburgh, Pennsylvania.
Joseph J EronDepartment of Medicine, University of North Carolina at Chapel Hill.
AIDS Clinical Trials 5326 Study Team
Bristol-Myers Squibb (United States) · USHarvard University · USInstitut de Recherche Vaccinale · FRUniversity of North Carolina at Chapel Hill · USUniversity of Pittsburgh · USNational Institute of Allergy and Infectious Diseases · USTufts University · USUniversity of Alabama · US

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
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit 2024 SupplementUM1AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, MINA CHRISTINE HOSSEINIPOUR · 2012 to 2026
$71.8M
HIV/SIV Replication In VivoZIAAI005014 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI KOUP, RICHARD A · 2009 to 2025
$22.7M
NIAID NIH HHS P30 AI050410NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI106701
6 · The paper itself

Abstract

Background: Reversing immune exhaustion with an anti-PD-L1 antibody may improve human immunodeficiency virus type 1 (HIV-1)-specific immunity and increase clearance of HIV-1-expressing cells. Methods: We conducted a phase I, randomized, double-blind, placebo-controlled, dose-escalating study of BMS-936559, including HIV-1-infected adults aged >18 to <70 years on suppressive antiretroviral therapy with CD4+ counts >350 cells/μL and detectable plasma HIV-1 RNA by single-copy assay. Data on single infusions of BMS-936559 (0.3 mg/kg) versus placebo are described. The primary outcomes were safety defined as any grade 3 or greater or immune-related adverse event (AE) and the change in HIV-1 Gag-specific CD8+ T cell responses from baseline to day 28 after infusion. Results: Eight men enrolled: 6 received 0.3 mg/kg of BMS-936559, and 2 received placebo infusions. There were no BMS-936559-related grade 3 or greater AEs. In 1 participant, asymptomatic hypophysitis (a protocol-defined immune-related AE) was identified 266 days after BMS-936559 infusion; it resolved over time. The mean percentage of HIV-1 Gag-specific CD8+ T cells expressing interferon γ increased from baseline (0.09%) through day 28 (0.20%; P = .14), driven by substantial increases in 2 participants who received BMS-936559. Conclusions: In this first evaluation of an immunologic checkpoint inhibitor in healthy HIV-1-infected persons, single low-dose BMS-936559 infusions appeared to enhance HIV-1-specific immunity in a subset of participants. Clinical Trials Registration: NCT02028403.

Indexed as

AdultAntibodies, MonoclonalAnti-Retroviral AgentsB7-H1 AntigenCD8-Positive T-LymphocytesHIV-1HIV InfectionsHumansMaleMiddle AgedAntibodies, MonoclonalAnti-Retroviral AgentsB7-H1 AntigenCD274 protein, humananti-PD-L1BMS-936559checkpoint inhibitorsHIV cureHIV eradicationhuman immunodeficiency virus type 1 (HIV-1)immune response

Identifiers

PMID28431010
PMCPMC5790148
OpenAlexW2605530771

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.