The Effect of Aspirin on HIV Disease Progression Among HIV- Infected Individuals Initiating Anti- Retroviral Therapy
Status:
Suspended
Trial end date:
2023-06-22
Target enrollment:
Participant gender:
Summary
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). The investigators present a protocol for a larger suspended
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 intended to recruit 454 consenting ARV drug-naïve, HIV-infected adults
initiating ART. Participants were 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.
Phase:
Phase 2
Details
Lead Sponsor:
Muhimbili University of Health and Allied Sciences
Collaborators:
Fogarty International Center of the National Institute of Health Kumamoto University