Abstract:
Introduction 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.
Methods and analysis 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.
Ethics and dissemination 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
