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HART-CT

In patients taking Protease Inhibitors does switching to a Bictegravir, Tenofovir Alafenamide and Emtricitabine combination, red

HART-CT

In patients taking Protease Inhibitors does switching to a Bictegravir, Tenofovir Alafenamide and Emtricitabine combination, red
Funding Gilead Pharmaceuticals
Portfolio Clinical Specialties
Interventions Medicine
Randomised Yes
Status Funding awarded/in set-up
Start Date

There is currently an unmet need in cardiovascular disease prevention in participants diagnosed with HIV. This is attributable to longer life expectancy with HIV participants succumbing to traditional age-related diseases. The complex interplay of risk factors, chronic inflammation and anti-retroviral therapy (ART) drives the significantly increased prevalence of cardiovascular disease in this group.

There have been no randomised controlled trials powered to investigate cardiovascular risk between different ART therapies. The use of non-calcified plaque volume change and reduction in high risk plaque features, as delineated by computed tomography coronary angiography (CTCA), as a surrogate for cardiovascular risk is novel in this setting.

We have designed an open label, prospective, randomised-control pilot study to investigate the feasibility of performing a fully powered multi-centred randomised control trial to investigate the hypothesis that participants who are HIV positive, and have evidence of subclinical cardiovascular disease on CTCA, will show reduced plaque progression when switching from protease inhibitor based combined ART to Bictegravir/Emtricitabine/Tenofovir alafenamide.

Publications

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