Human immunodeficiency virus (HIV) and cardiovascular disease (CVD) MedDRA version: 20.1 Level: PT Classification code 10003581 Term: Asymptomatic HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Bictravy
Product Name: Bictravy
Product Code: EU/1/18//1289/001
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Bictegravir
Concentration unit: mg milligram(s)
Concentration t
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: • Active liver disease (previously diagnosed) • Renal disease (eGFR 25mSv from medical sources. ** A definition of cardiovascular disease includes documented angina, previous myocardial infarction or previous coronary revascularization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We will assess the acceptability and suitability of the trial design (including CRF and PIS). This will be assessed by rate of drop out and overall rate of recruitment. The rate of recruitment will also be a determinate factor of the feasibility of any future fully powered study. To investigate that switching from PI based cART to Biktarvy will result in detectable levels of plaque change on serial CTCA though 48 weeks. This will be assessed by change in TPV, TNCPV, TCPV, SIS, SSS, Agatston score, diameter stenosis and adverse plaque characteristics. We will calculate the standard deviation of these changes to obtain the required sample size for a future appropriately powered randomised control trial. Patients will be recruited from the Royal Liverpool Regional HIV cohort Patients in both arms of the study will receive routine cardiology care. This may include secondary disease prevention, functional imaging or invasive coronary angiography. Patients in this higher risk category woul;Secondary Objective: The CT based scoring tools (MESA and ASTROCHARM calculators) will also be compared to the change in cardiovascular risk derived from traditional scoring systems including QRISK2. We will assess the prevalence of subclinical cardiovascular disease in our UK HIV cohort. We will calculate the precision of these CT based measures by assessing the interobserver and intraobserver variability. We will assess the change in lipid profile and HBA1C. This may give insight on how changes in metabolic profiles (insulin resistance, lipid profile and levels of inflammation) impact on plaque progression / regression and plaque morphology on serial CTCA. We will measure the change in Fibroscan score (KPa). Exploratory objectives include to assess how changing ART influences insulin resistance as measured by Kraft testing.;Primary end point(s): A quantitative assessment on the change in plaque on serial CTCA to include total plaque volume, calcified plaque vol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Inter and intraobserver variability of measures of plaque on CTCA The incidence of subclinical cardiovascular disease in the study population The change in in 10-year cardiovascular disease risk between the control group and intervention group using both prediction models. Change in total cholesterol, High-density lipoprotein, low-density lipoprotein, non-high-density lipoprotein and HBA1C. Baseline prevalence of fatty liver based on Fibroscore. Change in the fibroscore between the control group and intervention group Exploratory Outcomes Baseline measurement and subsequent change in the following markers of insulin sensitivity: C-peptide, Kraft testing, HOMA-IR Safety endpoints Any major infection, major adverse cardiac event. HIV safety endpoints – HIV viral load, CD4 count and CD4/CD8 ratio. ;Timepoint(s) of evaluation of this end point: 48 weeks | — |
Countries
United Kingdom
Contacts
Public ContactProfessor Saye Khoo
University of Liverpool
Outcome results
None listed