Table 2.
Day 0 | Week 4 | Week 24 | Week 48 | |
Informed consent | x | |||
Randomisation | x | |||
Demographics* | x | |||
Framingham Risk Score | x | x | x | |
SF-12† | x | x | x | |
Body weight | x | x | x | |
Vital signs | x | x | x | |
Blood tests‡ | x | x | x | |
HIV safety blood tests§ | x | x | x | x |
Transient elastography/Controlled Attenuated Parameter | x | x | x | |
CT¶ | (x) | (x) | (x) | |
DEXA** | x | x | x | |
cIMT†† | x | x | x | |
MRI substudy | ||||
Cardiac MRI‡‡ | x | x | ||
24 hours ECG Holter monitoring | x | x |
*Age, gender, tobacco use, alcohol consumption, medication, medical history, nursing home residency and activities of daily living.
†12-Item Short-Form Health Survey (SF-12).
‡HIV safety blood tests: Plasma HIV-RNA and CD4 count.
§Blood tests: leucocytes, platelets, haemoglobin, creatinine, urea, sodium, potassium, bilirubin, alanine aminotransferase, lactate dehydrogenase, erythrocyte fraction. Metabolism: Fasting p-glucose, insulin, glycated haemoglobin, total cholesterol, high-density lipoprotein, low-density lipoprotein, very low-density lipoprotein, triglyceride. Inflammation: High-sensitive C reactive protein, interleukin 1 and 6. Coagulation: D-dimer, factor 2, 7 and 10, fibrinogen. Platelet function: soluble P-selectin, soluble glycoprotein VI. Endothelial function: Vascular cell adhesion molecule 1, intercellular adhesion molecule 1, cardiac: N-terminal pro-B-type natriuretic peptide, troponin T.
¶Low dose CT of thorax and abdomen to determine coronary artery calcium score, visceral adipose tissue, subcutaneous adipose tissue and liver steatosis.
**Dual energy X-ray absorptiometry (DEXA), optional.
††Carotid intima-media thickness (cIMT) determined by ultrasound.
‡‡Cardiac MRI substudy (optional).
§§Blood pressure, heart rate