How does changing antiretroviral therapy effect the progression of coronary atherosclerosis.

Phase 1

• Conditions: Human immunodeficiency virus (HIV) and cardiovascular disease (CVD); MedDRA version: 20.1Level: PTClassification code 10003581Term: Asymptomatic HIV infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-005033-22-GB
• Lead Sponsor: niversity of Liverpool

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-16
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

•HIV positive
•Undetectable viral load on cART which contain protease inhibitors (duration >6 months at eligibility visit)
•Age>40 years at recruitment visit
•Stable cART*
•No previous documented cardiovascular disease
•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.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Active liver disease (previously diagnosed)
•Renal disease (eGFR <30)
•Any ongoing infection
•Signficant 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

*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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified