Prevention of atherosclerosis in patients living with HIV

Figures & data

Figure 1 Protocol design for C-IMT assessment and hs-CRP measurement.

Table 1 Detailed breakdown of screening visits

Time (days)	Pre-screening visit	Baseline visit	Follow-up
	28 to 14 days earlier	Day 1	Month 2	Month 6	Month 12	Month 18	Month 24
Informed consent	X
Demographic data	X
Medical history/concomitant disease	X
Physical examination	X	X		X	X	X	X
Vital signs	X	X		X	X	X	X
ECG	X	X	X	X	X	X	X
Weight	X	X		X	X	X	X
Height	X
Urinalysis1	X	X	X
Hematology2	X	X	X	X	X	X	X
Clinical chemistry3	X	X	X	X	X	X
Vascular inflammation marker4		X		X	X	X	X
C-IMT5		X		X	X	X	X
Adherence questioning and compliance check				X	X	X	X
Adverse events		X	X	X	X	X	X
Drug dispensing		X		X	X	X
Concomitant medication check	X	X	X	X	X	X	X

¹ Urinalysis including drug screen and pregnancy test (female subjects).

² With a differential and clotting screen.

³ Fasting for at least 10 hours and including creatinine, urea, potassium, sodium, bicarbonate, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, calcium, phosphate, liver function tests (ALT, AST, GGT), albumin, glucose, amylase and C-reactive protein (CRP).

⁴ Vascular inflammation marker highly sensitive CRP (hs-CRP).

⁵ Carotid ultrasound – C-IMT measurement.