Coronary Artery DiseasePhase 4HART CTNCT03986697
How Does Antiretroviral Therapy Affect Coronary Atherosclerosis: a Serial CT Study
A Phase 4 study testing Biktarvy in people with Coronary Artery Disease and Hiv, run by University of Liverpool at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Coronary Artery Disease, Hiv
- What is being tested?
- Biktarvy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Feb 2020to 29 Mar 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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)
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Coronary Artery Disease, Hiv
- Being tested
- Biktarvy
- Keywords
- HIV, Coronary Artery Disease, Atherosclerosis, Antiretroviral therapy, Computed tomography
- Medical subject headings
- Coronary Artery Disease, Acquired Immunodeficiency Syndrome, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiktarvyDrug
Fixed dose combination preparation containing bictegravir, tenofovir alafenamide and emtricitabine
| Study group | Role | What they receive |
|---|---|---|
| Bictarvy | Active comparator | Intervention group: those randomised to switch antiretroviral therapy to Bictegravir, Emtricitabine and Tenofovir Alafenamide fixed dose combination. Receives: Drug: Biktarvy |
| Usual therapy | No intervention | Control group: those randomised to continue their usual antiretroviral regime |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of recruitment to the HART CT study
Rate of recruitment to the main study expressed as a rate of eligible patients screened to those who undergo randomisation.
Measured: 2 years
Drop out rate
Drop out rate of the main study. The number of participants not completing the study expressed as a percentage of those recruited.
Measured: 2 years
Change in total plaque volume (mm3) including the following derivatives: total non-calcified plaque volume (mm3), calcium volume (mm3). These derivatives will be combined to give a total plaque volume (mm3).
CT based quantification of coronary artery disease burden. Assessed using summary statistics and parametric or non-parametric measures of significance.
Measured: 2 years
Change in Agatston Score (Agatston units).
Agatston calcium scoring is a highly reproducible well validated scale outlining the burden of calcific coronary artery disease. Agatston score is a function of calcium volume and density. The volume is calculated in mm3 and multiplied by a density weighting factor depending on the haunsfied units.
Change in Agatston scores will be assessed using summary statistics and parametric or non-parametric measures of significance.
Measured: 2 years
Change in segmental stenosis score
Coronary segments are graded as normal (no stenosis), stenosis 1%-29%, 30%-49%, 50%-69%, ≥70% by visual semiquantification method, with assignment of scores of 0, 1, 2, 3, or 4, respectively. Stenosis is not measured when the vessel diameter was <2 mm. Total segment stenosis score (TSS) per person is calculated by summing all the 15 individual SSSs with a possible score ranging from 0 to 60.
Change in segmental stenosis scores will be assessed using summary statistics and parametric or non-parametric measures of significance.
Measured: 2 years
Number of adverse plaque features
The change in the number of coronary segments displaying an adverse plaque characterisitc. This is defined as any one of the following (low attenuation plaque (<30 hounsfield units), positive remodelling (remodelling index >1.1), spotty calcification or napkin ring sign).
Change in number of adverse plaque features will be assessed using summary statistics and parametric or non-parametric measures of significance.
Measured: 2 years
Secondary outcomes (6)
Inter and intraobserver variability of CT based outcome measures
To assess the inter and intraobserver variability of total plaque volume (mm3). This will be assessed for the first 20 vessels containing evidence of coronary artery disease between the two study reporters.
The mean difference (%) will be reported.
Measured: 2 years
The incidence of subclinical cardiovascular disease in the study population
Expressed as percentage of recruited patients.
Measured: 2 years
The change in in 10-year cardiovascular disease risk between the control group and intervention group using both prediction models.
Summary statistics (mean) assessment of the change in 10 year cardiovascular disease risk as assessed by QRISK and ASTROCHARM risk prediction models. The 10 year cardiovascular risk will be reported as %.
The intervention group and control group compared using parametric or non-parametric measures of significance.
Measured: 2 years
Change in total cholesterol (mmol/L) including the derivatives (which are combined to give the total cholesterol) high-density lipoprotein (mmol/L), low-density lipoprotein (mmol/L) and non-high-density lipoprotein (mmol/L).
Intervention group and control group compared using parametric or non-parametric measures of significance. The range of cholesterol is 0-20 mmol/L
Measured: 2 years
Fibroscore (Kilopascals)
Change from baseline to end fibroscan score. Intervention group and control group compared using parametric or non-parametric measures of significance.
The range of KPa is 0-75.
Measured: 2 years
Change in HBA1C (mmol/mol)
Intervention group and control group compared using parametric or non-parametric measures of significance.
The range of HBA1C is 0-150mmol/mol.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start4 Feb 2020
- Primary completion29 Mar 2021 (estimated)
- Study completion29 Mar 2021 (estimated)
Why it stopped: COVID19 emergency. No patients randomised
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986697
- Sponsor's protocol ID
- UoL001362
- Other IDs
- 2017-005033-22, 2017
- Acronym
- HART CT
- Status last verified
- Sep 2019
- First submitted
- 30 May 2019
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03986697
- Acronym / sponsor ID
- HART CT / UoL001362
- Conditions
- Coronary Artery Disease, Hiv
- Keywords
- HIV, Coronary Artery Disease, Atherosclerosis, Antiretroviral therapy, Computed tomography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID19 emergency. No patients randomised
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 29 Mar 2021 (estimated)
- Study completion
- 29 Mar 2021 (estimated)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bictarvy | Active comparator | Drug: BiktarvyIntervention group: those randomised to switch antiretroviral therapy to Bictegravir, Emtricitabine and Tenofovir Alafenamide fixed dose combination. |
| Usual therapy | No intervention | –Control group: those randomised to continue their usual antiretroviral regime |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- Active liver disease (previously diagnosed)
- Renal disease eGFR <30
- Any ongoing infection
- Significant ionising radiation in preceding 12 months
- Known or suspected cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiktarvyFixed dose combination preparation containing bictegravir, tenofovir alafenamide and emtricitabine | Drug | Bictarvy |
Primary outcome
The rate of recruitment to the HART CT study
Time frame: 2 years
Rate of recruitment to the main study expressed as a rate of eligible patients screened to those who undergo randomisation.
Drop out rate
Time frame: 2 years
Drop out rate of the main study. The number of participants not completing the study expressed as a percentage of those recruited.
Change in total plaque volume (mm3) including the following derivatives: total non-calcified plaque volume (mm3), calcium volume (mm3). These derivatives will be combined to give a total plaque volume (mm3).
Time frame: 2 years
CT based quantification of coronary artery disease burden. Assessed using summary statistics and parametric or non-parametric measures of significance.
Change in Agatston Score (Agatston units).
Time frame: 2 years
Agatston calcium scoring is a highly reproducible well validated scale outlining the burden of calcific coronary artery disease. Agatston score is a function of calcium volume and density. The volume is calculated in mm3 and multiplied by a density weighting factor depending on the haunsfied units. Change in Agatston scores will be assessed using summary statistics and parametric or non-parametric measures of significance.
Change in segmental stenosis score
Time frame: 2 years
Coronary segments are graded as normal (no stenosis), stenosis 1%-29%, 30%-49%, 50%-69%, ≥70% by visual semiquantification method, with assignment of scores of 0, 1, 2, 3, or 4, respectively. Stenosis is not measured when the vessel diameter was <2 mm. Total segment stenosis score (TSS) per person is calculated by summing all the 15 individual SSSs with a possible score ranging from 0 to 60. Change in segmental stenosis scores will be assessed using summary statistics and parametric or non-parametric measures of significance.
Number of adverse plaque features
Time frame: 2 years
The change in the number of coronary segments displaying an adverse plaque characterisitc. This is defined as any one of the following (low attenuation plaque (<30 hounsfield units), positive remodelling (remodelling index >1.1), spotty calcification or napkin ring sign). Change in number of adverse plaque features will be assessed using summary statistics and parametric or non-parametric measures of significance.
6 secondary outcomes
Inter and intraobserver variability of CT based outcome measures
Time frame: 2 years
The incidence of subclinical cardiovascular disease in the study population
Time frame: 2 years
The change in in 10-year cardiovascular disease risk between the control group and intervention group using both prediction models.
Time frame: 2 years
Change in total cholesterol (mmol/L) including the derivatives (which are combined to give the total cholesterol) high-density lipoprotein (mmol/L), low-density lipoprotein (mmol/L) and non-high-density lipoprotein (mmol/L).
Time frame: 2 years
Fibroscore (Kilopascals)
Time frame: 2 years
Change in HBA1C (mmol/mol)
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Biktarvy in people with Coronary Artery Disease and Hiv, run by University of Liverpool at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of recruitment to the HART CT study (time frame: 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.