Evidence mapPaperPMID 40880360Full record

Trial reportPloS one2025

Low-dose aspirin is not effective as an adjunct treatment for HIV infection among people living with HIV on dolutegravir-based antiretroviral therapy: A randomised double-blind, parallel-group placebo-controlled trial.

Tosi M Mwakyandile, Grace A Shayo, Philip G Sasi, Peter P Kunambi, Ferdinand M Mugusi, Godfrey Barabona, Takamasa Ueno, Eligius F Lyamuya

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05525156 (The Effect of Aspirin on HIV Disease Progression Among HIV- Infected Individuals Initiating Anti- Retroviral Therapy), which is not on this map. Not yet cited in PubMed.

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

NCT05525156 phase2suspendednot on this map

The Effect of Aspirin on HIV Disease Progression Among HIV- Infected Individuals Initiating Anti- Retroviral Therapy

TypeinterventionalSponsorMuhimbili University of Health and Allied SciencesRan2020 to 2023Enrolled454ConditionsHiv, Cardiovascular DiseasesArmsaspirin enteric coated tablet 75 mg
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

8 authors.

Tosi M MwakyandileDepartment of Clinical Pharmacology, School of Biomedical Sciences, Campus College of Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.ORCID https://orcid.org/0000-0002-5073-1923
Grace A ShayoDepartment of Internal Medicine, School of Clinical Medicine, Campus College of Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Philip G SasiDepartment of Clinical Pharmacology, School of Biomedical Sciences, Campus College of Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Peter P KunambiDepartment of Clinical Pharmacology, School of Biomedical Sciences, Campus College of Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Ferdinand M MugusiDepartment of Internal Medicine, School of Clinical Medicine, Campus College of Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Godfrey BarabonaDivision of Infection and Immunity, Joint Research Centre for Human Retrovirus Infection, Kumamoto University, Kumamoto, Japan.
Takamasa UenoDivision of Infection and Immunity, Joint Research Centre for Human Retrovirus Infection, Kumamoto University, Kumamoto, Japan.ORCID https://orcid.org/0000-0003-4852-4236
Eligius F LyamuyaDepartment of Microbiology and Immunology, School of Diagnostic Medicine, Campus College of Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.ORCID https://orcid.org/0000-0002-0136-2826

Funding

HIS : Training Tanzanian Researchers for HIV/AIDS Implementation Science (Renewal)D43TW009775 · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · 2025 to 2025
$295k
FIC NIH HHS D43 TW009775
6 · The paper itself

Abstract

backgroundDespite virologic suppression with antiretroviral therapy (ART), immune activation (IA) in people living with HIV (PLHIV) remains high and is linked to non-AIDS complications. Alongside its other virologic and immunologic benefits, aspirin promisingly appears to lower the residual IA in PLHIV in small studies.

methodsWe conducted a double-blind, parallel-group randomised trial involving ART-naïve PLHIV initiating ART at recruitment. Participants were randomly assigned (1:1) to receive 75 mg aspirin or placebo daily for 24 weeks, alongside standard of care. The primary outcome was proportion of participants attaining HIV viral load < 50 RNA copies/mL at weeks 8, 12 and 24. Secondary outcomes assessed at 12 and 24 weeks were CD4 count, platelet and monocyte activation (soluble P-selectin and soluble CD14, respectively), T-cell activation (CD69 expression, CD38/HLA-DR co-expression) and T-cell exhaustion (PD-1 expression). Data were analysed by intention-to-treat strategy. Between-treatment arm comparisons were made by regression models using generalised estimating equations. Competing risk analyses were employed for morbidity, all-cause mortality and adverse events (AE).

resultsOut of 430 recruited participants, 216 were randomised to aspirin and 214 to placebo arms, with 112 and 131 participants completing the study, respectively. Proportions of participants attaining primary outcome at week 24 were comparable (78.4% aspirin arm versus 80.67% placebo arm, p = 0.53). There was larger decrease in CD8+CD69+ (%) at 12 weeks only in the placebo arm (median change (IQR): -0.42 (-2.07, 0.33) versus -0.06 (-1.30, 0.90) in the aspirin arm, p = 0.04). Other markers and secondary outcomes: morbidity (35.6% versus 34.5%), mortality (4.63 versus 3.27 per 100 person-weeks) and AEs (96.7% versus 98.0%) were similar between the aspirin and placebo arms, respectively, p > 0.05.

conclusionsLow-dose aspirin initiated alongside ART through 24 weeks did not impact virologic or immunologic markers among PLHIV.

trial registrationPACTR202003522049711, NCT05525156.

Indexed as

Anti-HIV AgentsAspirinHeterocyclic Compounds, 3-RingHIV InfectionsAdultCD4 Lymphocyte CountDolutegravirDouble-Blind MethodFemaleHumansMaleMiddle AgedOxazinesPiperazinesPyridonesTreatment OutcomeAnti-HIV AgentsAspirinDolutegravirHeterocyclic Compounds, 3-RingOxazinesPiperazinesPyridones

Identifiers

PMID40880360
PMCPMC12396663

What Socratic 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 Socratic graph.