How Does Antiretroviral Therapy Affect Coronary Atherosclerosis: A Serial CT Study (HART CT)
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ClinicalTrials.gov Identifier: NCT03986697 |
Recruitment Status :
Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : September 30, 2019
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Tracking Information | |||||||
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First Submitted Date ICMJE | May 30, 2019 | ||||||
First Posted Date ICMJE | June 14, 2019 | ||||||
Last Update Posted Date | September 30, 2019 | ||||||
Estimated Study Start Date ICMJE | November 4, 2019 | ||||||
Estimated Primary Completion Date | November 28, 2020 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | How Does Antiretroviral Therapy Affect Coronary Atherosclerosis: A Serial CT Study | ||||||
Official Title ICMJE | 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 | ||||||
Brief Summary | 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. |
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Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Biktarvy
Fixed dose combination preparation containing bictegravir, tenofovir alafenamide and emtricitabine
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||
Estimated Enrollment ICMJE |
100 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | March 29, 2021 | ||||||
Estimated Primary Completion Date | November 28, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
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:
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. |
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Sex/Gender ICMJE |
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Ages ICMJE | 40 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | |||||||
Listed Location Countries ICMJE | Not Provided | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03986697 | ||||||
Other Study ID Numbers ICMJE | UoL001362 2017-005033-22 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Professor Saye Khoo MD, FRCP, University of Liverpool | ||||||
Study Sponsor ICMJE | Professor Saye Khoo MD, FRCP | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE | Not Provided | ||||||
PRS Account | University of Liverpool | ||||||
Verification Date | September 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |