Coronary Artery Disease Clinical Trial
Official title:
In Patients Taking Protease Inhibitors Does Switching to a Bictegravir, Tenofovir Alafenamide and Emtricitabine Combination, Reduce Cardiovascular Risk: An Open-label, Randomised, Serial CT Pilot Study
Combined antiretroviral therapy (cART) is thought to promote coronary artery disease via a
number of mechanisms: abnormal lipid profiles, endothelial dysfunction, hypertension, insulin
resistance and renal impairment are the main pathological mechanisms driving atherosclerosis
as a consequence of cART. An association between protease inhibitors and increased
cardiovascular disease risk has been shown in many large cohort trials.
CT Coronary Angiography (CTCA) is now widely used to assess for the presence of
atherosclerosis, typically in patients presenting with chest pain. This imaging technique
allows visualisation of the coronary arteries and quantification of any atherosclerotic
disease that may be present. This technique is being increasingly used as a surrogate for
cardiovascular disease risk.
HART CT is an open label, prospective, randomised-control pilot study to investigate the
feasibility of performing a future appropriately powered multi-centred randomised control
trial using CT based outcome data as a surrogate for cardiovascular disease risk.
Participants will be randomised to either continue their usual cART or switch to Biktarvy (a
fixed dose combination of bictegravir, emtricitabine and tenofovir alafenamide). A baseline
CT scan will be performed. If there is any evidence of atherosclerosis a further CT scan will
be performed at the end of the study (approximately 48 weeks). This will allow quantification
of any change in coronary artery plaque burden or characteristic. Participants will be also
followed up for any changes in metabolic health.
n/a
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