Department of Clinical Pharmacology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania
Department of Internal Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
BMJ Open. 2021 Nov 2;11(11):e049330. doi: 10.1136/bmjopen-2021-049330.
An increase in cardiovascular disease (CVD) among people living with HIV infection is linked to platelet and immune activation, a phenomenon unabolished by antiretroviral (ARV) drugs alone. In small studies, aspirin (acetylsalicylic acid [ASA]) has been shown to control immune activation, increase CD4+ count, halt HIV disease progression and reduce HIV viral load (HVL). We present a protocol for a larger ongoing randomised placebo controlled trial on the effect of an addition of ASA to ARV drugs on HIV disease progression.
A single-centre phase IIA double-blind, parallel-group randomised controlled trial intends to recruit 454 consenting ARV drug-naïve, HIV-infected adults initiating ART. Participants are randomised in blocks of 10 in a 1:1 ratio to receive, in addition to ARV drugs, 75 mg ASA or placebo for 6 months. The primary outcome is the proportion of participants attaining HVL of <50 copies/mL by 8, 12 and 24 weeks. Secondary outcomes include proportions of participants with HVL of >1000 copies/mL at week 24, attaining a >30% rise of CD4 count from baseline value at week 12, experiencing adverse events, with normal levels of biomarkers of platelet and immune activation at weeks 12 and 24 and rates of morbidity and all-cause mortality. Intention-to-treat analysis will be done for all study outcomes.
Ethical approval has been obtained from institutional and national ethics review committees. Findings will be submitted to peer-reviewed journals and presented in scientific conferences.
PACTR202003522049711.
在感染 HIV 的人群中，心血管疾病（CVD）的增加与血小板和免疫激活有关，而抗逆转录病毒（ARV）药物单独治疗并不能消除这种现象。在小型研究中，阿司匹林（乙酰水杨酸[ASA]）已被证明可控制免疫激活、增加 CD4+计数、阻止 HIV 疾病进展并降低 HIV 病毒载量（HVL）。我们提出了一项正在进行的更大规模的随机安慰剂对照试验方案，研究在 ARV 药物中添加 ASA 对 HIV 疾病进展的影响。
一项单中心 IIA 期双盲、平行组随机对照试验计划招募 454 名同意接受 ARV 药物治疗、初次接受抗逆转录病毒治疗的 HIV 感染成年人。参与者以 10 人为一组按 1:1 的比例随机分组，除了接受 ARV 药物治疗外，还分别额外接受 75mg ASA 或安慰剂治疗 6 个月。主要结局是在第 8、12 和 24 周时达到 HVL<50 拷贝/mL 的参与者比例。次要结局包括在第 24 周时 HVL>1000 拷贝/mL 的参与者比例、在第 12 周时 CD4 计数较基线值升高>30%的参与者比例、出现不良事件的比例、在第 12 和 24 周时血小板和免疫激活的生物标志物水平正常的比例以及发病率和全因死亡率。所有研究结局均采用意向治疗分析。
机构和国家伦理审查委员会已批准了伦理。研究结果将提交给同行评议的期刊，并在科学会议上展示。
PACTR202003522049711。
