How Does Antiretroviral Therapy Affect Coronary Atherosclerosis: A Serial CT Study (HART CT)
Coronary Artery Disease, Hiv
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring HIV, Coronary Artery Disease, Atherosclerosis, Antiretroviral therapy, Computed tomography
Eligibility Criteria
- HIV positive
- Undetectable viral load on cART which contain protease inhibitors (duration >6 months at eligibility visit)
- Age>40 years
- Stable cART
- No previous documented cardiovascular disease
- No contraindication to study drug
- Ability to give informed consent
- Willingness to comply with all study requirements
- No symptoms of overt cardiovascular disease
A definition of stable cART is no change to the medication regime in the preceding 6 months.
Well controlled hypertension is considered acceptable for recruitment.
Exclusion Criteria:
- Active liver disease (previously diagnosed)
- Renal disease eGFR <30
- Any ongoing infection
- Significant ionising radiation in preceding 12 months
- Known or suspected cardiovascular disease
- High dose statin therapy (Atorvastatin 20mg or more, Rosuvastatin 20mg or more)
- Pregnancy or planned pregnancy
- Breast feeding
- Allergy to iodine based contrast agent
- Known drug resistance to NRTI or Integrase
- Any contraindication to BIC/FTC/TAF
- Current enrolment onto another CTIMP.
Significant ionising radiation should not exceed >25mSv from medical sources. A definition of cardiovascular disease includes documented angina, previous myocardial infarction or previous coronary revascularization.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
Bictarvy
Usual therapy
Intervention group: those randomised to switch antiretroviral therapy to Bictegravir, Emtricitabine and Tenofovir Alafenamide fixed dose combination.
Control group: those randomised to continue their usual antiretroviral regime