对于接受基于多替拉韦的抗逆转录病毒治疗的HIV感染者，低剂量阿司匹林作为HIV感染的辅助治疗无效：一项随机双盲、平行组安慰剂对照试验。
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.
作者信息
Mwakyandile Tosi M, Shayo Grace A, Sasi Philip G, Kunambi Peter P, Mugusi Ferdinand M, Barabona Godfrey, Ueno Takamasa, Lyamuya Eligius F
机构信息
Department of Clinical Pharmacology, School of Biomedical Sciences, Campus College of Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Department of Internal Medicine, School of Clinical Medicine, Campus College of Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
出版信息
PLoS One. 2025 Aug 29;20(8):e0331087. doi: 10.1371/journal.pone.0331087. eCollection 2025.
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.
背景
尽管抗逆转录病毒疗法（ART）可实现病毒学抑制，但人类免疫缺陷病毒感染者（PLHIV）的免疫激活（IA）水平仍然很高，且与非艾滋病并发症相关。在小型研究中，阿司匹林除了具有其他病毒学和免疫学益处外，似乎还有望降低PLHIV的残余IA水平。
方法
我们进行了一项双盲、平行组随机试验，纳入了在招募时开始接受ART的初治PLHIV。参与者被随机分配（1:1），在接受标准治疗的同时，每天服用75毫克阿司匹林或安慰剂，持续24周。主要结局是在第8周、12周和24周时，HIV病毒载量＜50 RNA拷贝/mL的参与者比例。在第12周和24周评估的次要结局包括CD4细胞计数、血小板和单核细胞激活（分别为可溶性P-选择素和可溶性CD14）、T细胞激活（CD69表达、CD38/HLA-DR共表达）以及T细胞耗竭（PD-1表达）。数据采用意向性分析策略进行分析。治疗组间的比较采用使用广义估计方程的回归模型。对发病率、全因死亡率和不良事件（AE）进行竞争风险分析。
结果
在430名招募的参与者中，216人被随机分配到阿司匹林组，214人被随机分配到安慰剂组，分别有112名和131名参与者完成了研究。在第24周达到主要结局的参与者比例相当（阿司匹林组为78.4%，安慰剂组为80.67%，p = 0.53）。仅在第12周时，安慰剂组的CD8+CD69+（%）下降幅度更大（中位数变化（IQR）：-0.42（-2.07，0.33），而阿司匹林组为-0.06（-1.30，0.90），p = 0.04）。其他标志物和次要结局：发病率（35.6%对34.5%）、死亡率（每100人周4.63对3.27）和AE（96.7%对98.0%）在阿司匹林组和安慰剂组之间分别相似，p＞0.05。
结论
在ART治疗的同时开始服用低剂量阿司匹林并持续24周，对PLHIV的病毒学或免疫学标志物没有影响。
试验注册
PACTR202003522049711，NCT05525156。
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