Schedule of events
Visit no | Study visits | |||||
Week, day | ||||||
W-4 to −1 Screening | W0, D1 Baseline | W1, D1 (±1 day) | W4, D1 (±3 days) | W12, D1 (±3 days) | W24, D1 (±3 days) | |
V1 | V2 | V3 | V4 | V5 | V6/final | |
Consent form | X | X | ||||
Medical history | X | |||||
Concomitant medication | X | X | X | X | X | |
Eligibility criteria | X | X | ||||
Physical examination | X | X | X | X | ||
Adverse events | X | X | X | X | X | |
Haematology* | X | X | X | X | ||
Chemistry† | X | X | X | X | ||
T-cell activation and inflammatory markers | X | X | X | |||
HIV viral load | X | X | X | X | X | |
Size of HIV reservoir in latently infected CD4+ T cells | X | X | X | |||
Urine pregnancy test | X | X | ||||
Metformin administration | X | X | X | |||
Colon mucosal biopsies‡ | X | X | ||||
Stool sample collection for microbiota analysis | X | X | X |
↵*Complete blood count, CD4+ and CD8+ T cell counts.
↵†AST, ALT, Alk Phos, total bilirubin, triglycerides, cholesterol, HDL, LDL, creatinine, blood glucose, lipase, amylase, urea, creatine kinase, serum phosphate and fasting glucose.
‡Optional procedure.
AST, aspartate aminotransferase; ALT, alanine aminotransferase; Alk Phos, alkaline phosphatase; HDL, high-density lipoprotein; LDL, low-density lipoprotein.