MedDataX Logo

How Does Antiretroviral Therapy Affect Coronary Atherosclerosis: a Serial CT Study

NCT ID: NCT03986697

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-04

Study Completion Date

2021-03-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease Hiv

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

HIV Coronary Artery Disease Atherosclerosis Antiretroviral therapy Computed tomography

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bictarvy

Intervention group: those randomised to switch antiretroviral therapy to Bictegravir, Emtricitabine and Tenofovir Alafenamide fixed dose combination.

Group Type ACTIVE_COMPARATOR

Biktarvy

Intervention Type DRUG

Fixed dose combination preparation containing bictegravir, tenofovir alafenamide and emtricitabine

Usual therapy

Control group: those randomised to continue their usual antiretroviral regime

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biktarvy

Fixed dose combination preparation containing bictegravir, tenofovir alafenamide and emtricitabine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Liverpool

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Royal Liverpool University Hospital

Liverpool, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-005033-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

UoL001362

Identifier Type: -

Identifier Source: org_study_id