article · PLoS ONE
People living with HIV often experience persistent immune activation despite achieving viral suppression with antiretroviral therapy, which is associated with non-AIDS complications. A randomised, double-blind, placebo-controlled trial evaluated whether adding daily low-dose aspirin to standard antiretroviral therapy helps address this issue. Newly treated participants were assigned to receive either 75 milligrams of aspirin or a placebo daily for 24 weeks alongside standard care. The primary goal was assessing the proportion of participants reaching viral suppression below 50 RNA copies per millilitre. At 24 weeks, rates of viral suppression were comparable between both groups. Furthermore, the trial found no notable differences in CD4 counts, platelet activation, monocyte activation, or T-cell exhaustion markers. Morbidity, mortality, and adverse events were also similar between the groups, demonstrating that low-dose aspirin did not alter virologic or immunologic outcomes.
Managing chronic immune activation in people living with HIV remains an important clinical challenge because it leads to long-term health complications. By testing an accessible, low-cost medication in a rigorous trial, this study provides clear evidence that low-dose aspirin does not offer therapeutic benefit as an adjunct treatment, helping clinicians avoid ineffective interventions.
The trial directly tests an off-label use of an existing generic drug in clinical practice. Because the findings show that low-dose aspirin is not effective as an adjunct therapy for viral or immunologic control in this population, the abstract indicates no viable application pathway or commercial opportunity for aspirin in this specific clinical context.
AI-generated from the published abstract. Always read the original work before citing.
BACKGROUND: Despite 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. METHODS: We 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). RESULTS: Out 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. CONCLUSIONS: Low-dose aspirin initiated alongside ART through 24 weeks did not impact virologic or immunologic markers among PLHIV. TRIAL REGISTRATION: PACTR202003522049711, NCT05525156.
This page summarises published work. The authoritative version sits with the publisher.
DOI: 10.1371/journal.pone.0331087
Is something wrong with this record? Report it or request removal.
Discussion
Have you built on this work, tried to replicate it, or seen it applied in practice? Share what you know. Verified researchers and MARATTO™ domain experts can open a discussion, and any member can reply. Contributions are reviewed before they appear.
No discussion yet. Open the first thread.
New to MARATTO™? Create a free account.
