Evidence map›Paper›PMID 40810569›Full record

Trial reportThe Journal of infectious diseases2025

Virological and Immunological Outcomes of Combined Therapeutic Interventions and Dendritic Cell Therapy in People With HIV.

Lishomwa C Ndhlovu, Leila B Giron, Juliana Galinskas, Thomas A Premeaux, Alina P S Pang, Danilo Dias, Marcella Vassão de Almeida Baptista, Iart Luca Shytaj, Juliana T Maricato, Paulo R A Ferreira and 12 more

Registry-linked trialAbstract readRandomized Controlled Trial
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 trial NCT06805656 (Multi Interventional Approaches to Mitigate HIV Reservoirs for the Sustained HIV Remission Without Use of Antiretrovirals), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT06805656 phase2recruitingnot on this mapstarted 2026, after this paper: background citation

Multi Interventional Approaches to Mitigate HIV Reservoirs for the Sustained HIV Remission Without Use of Antiretrovirals

TypeinterventionalSponsorFederal University of São PauloRan2026 to 2028Enrolled70ConditionsHiv, HIV I InfectionArmsMaraviroc, Dolutegravir, Dendritic Cell Vaccine, Auranofin, Sirtuin Histone deacetylase inhibitor
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. 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

22 authors.

Lishomwa C NdhlovuDepartment of Medicine, Division of Infectious Diseases, Weill Cornell Medicine, New York, New York, USA.ORCID 0000-0001-5427-4187
Leila B GironLaboratório de Retrovirologia, Escola Paulista de Medicina, Universidade Federal de São Paulo, Sao Paulo, Brazil.ORCID 0000-0002-3898-5680
Juliana GalinskasLaboratório de Retrovirologia, Escola Paulista de Medicina, Universidade Federal de São Paulo, Sao Paulo, Brazil.
Thomas A PremeauxDepartment of Medicine, Division of Infectious Diseases, Weill Cornell Medicine, New York, New York, USA.ORCID 0000-0002-2103-3421
Alina P S PangDepartment of Medicine, Division of Infectious Diseases, Weill Cornell Medicine, New York, New York, USA.ORCID 0000-0001-6677-7355
Danilo DiasLaboratório de Retrovirologia, Escola Paulista de Medicina, Universidade Federal de São Paulo, Sao Paulo, Brazil.ORCID 0000-0002-8517-600X
Marcella Vassão de Almeida BaptistaLaboratório de Retrovirologia, Escola Paulista de Medicina, Universidade Federal de São Paulo, Sao Paulo, Brazil.ORCID 0000-0002-6824-105X
Iart Luca ShytajLaboratório de Retrovirologia, Escola Paulista de Medicina, Universidade Federal de São Paulo, Sao Paulo, Brazil.ORCID 0000-0002-9980-1275
Juliana T MaricatoLaboratório de Retrovirologia, Escola Paulista de Medicina, Universidade Federal de São Paulo, Sao Paulo, Brazil.
Paulo R A FerreiraLaboratório de Retrovirologia, Escola Paulista de Medicina, Universidade Federal de São Paulo, Sao Paulo, Brazil.
Gisele GosuenLaboratório de Retrovirologia, Escola Paulista de Medicina, Universidade Federal de São Paulo, Sao Paulo, Brazil.
Michael J CorleyDepartment of Medicine, Division of Infectious Diseases, Weill Cornell Medicine, New York, New York, USA.ORCID 0000-0001-8957-7153
Courtney M FridayDepartment of Medicine, Division of Infectious Diseases, Weill Cornell Medicine, New York, New York, USA.
Scott A BowlerDepartment of Medicine, Division of Infectious Diseases, Weill Cornell Medicine, New York, New York, USA.ORCID 0000-0001-8881-6941
Ermelindo Della LiberaLaboratório de Retrovirologia, Escola Paulista de Medicina, Universidade Federal de São Paulo, Sao Paulo, Brazil.
Maria Cecilia SucupiraLaboratório de Retrovirologia, Escola Paulista de Medicina, Universidade Federal de São Paulo, Sao Paulo, Brazil.ORCID 0000-0002-1114-5382
James R HunterLaboratório de Retrovirologia, Escola Paulista de Medicina, Universidade Federal de São Paulo, Sao Paulo, Brazil.ORCID 0000-0001-9524-0629
Luis Mário JaniniLaboratório de Retrovirologia, Escola Paulista de Medicina, Universidade Federal de São Paulo, Sao Paulo, Brazil.
Mauro SchechterDepartamento de Doenças Infecciosas e Parasitárias, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.
Andrea SavarinoDepartment of Infectious Diseases, Italian Institute of Health, Rome, Italy.
Ricardo Sobhie DiazLaboratório de Retrovirologia, Escola Paulista de Medicina, Universidade Federal de São Paulo, Sao Paulo, Brazil.ORCID 0000-0002-8395-7304
SPARC Working Group

Funding

HOPE - HIV Obstruction by Programmed EpigeneticsUM1AI164559 · NIAID · J. DAVID GLADSTONE INSTITUTES · PI Lishomwa C Ndhlovu, Melanie Maria Ott · 2021 to 2026
$32.2M
Conselho Nacional de Desenvolvimento Científico e Tecnológico 441817/2018-1Conselho Nacional de Desenvolvimento Científico e Tecnológico CNPq-454700-2014-8Fundação de Apoio à Pesquisa do Estado de São Paulo 19/17461-7Fundação de Apoio à Pesquisa do Estado de São Paulo 20/10396-2Fundação de Apoio à Pesquisa do Estado de São Paulo 2013/11323-5NIAID NIH HHS UM1 AI164559NIH HHS UM1AI164559ViiV Healthcare Investigator Sponsored Study
6 · The paper itself

Abstract

backgroundExcept for hematopoietic cell transplantation, therapeutic-driven HIV-1 curative approaches have been unsuccessful. Here, we describe a 2-step randomized clinical trial designed to evaluate the safety and impact of individual and combinatorial therapeutic strategies on changes in peripheral and gut mucosal HIV reservoirs, immune activation and function in people with HIV with chronic disease and high CD4 T-cell nadirs.

methodsThirty participants were enrolled and randomized equally into 6 study arms based on treatments with either standard antiretroviral therapy (ART) alone or a combination of candidate anti-HIV reservoir strategies that included ART intensification, auranofin (an apoptotic-inducer antirheumatic drug), nicotinamide (vitamin B3), and a personalized dendritic cell therapy.

resultsAfter an analytical treatment interruption post intervention, all eligible participants rebounded within 14 weeks, except for 1 participant with rebound detected at 84 weeks and 2 participants receiving all combined therapies maintained viral loads below 1000 copies/mL through the study period. These posttreatment controllers all received nicotinamide containing regimens and exhibited immune cellular epigenetic age reversal.

conclusionsThis proof-of-concept clinical trial demonstrates the safety of multiple interventions with distinct antireservoir activities in people with HIV and argues for continued investigation of both single and combinatorial interventions towards posttherapy HIV control.

Indexed as

Anti-HIV AgentsDendritic CellsHIV-1HIV InfectionsAdultAuranofinCD4 Lymphocyte CountCombined Modality TherapyFemaleHumansMaleMiddle AgedNiacinamideTreatment OutcomeViral LoadAnti-HIV AgentsAuranofinNiacinamideantiretroviral therapy (ART)CCR5cureimmunotherapynicotinamide

Identifiers

PMID40810569
PMCPMC12614972

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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.