Table 1

Schedule of events

Visit noStudy 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)
V1V2V3V4V5V6/final
Consent formXX
Medical historyX
Concomitant medicationXXXXX
Eligibility criteriaXX
Physical examinationXXXX
Adverse eventsXXXXX
Haematology* XXXX
Chemistry XXXX
T-cell activation and inflammatory markersXXX
HIV viral loadXXXXX
Size of HIV reservoir in latently infected CD4+ T cellsXXX
Urine pregnancy testXX
Metformin administrationXXX
Colon mucosal biopsies‡XX
Stool sample collection for microbiota analysisXXX
  • *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.