Eligible subjects will be randomised in a 1:1 ratio (either to the control arm or to the intervention arm) for a total of 665 subjects per arm, using a computer-generated random list. They will be stratified by country and by CD4 cell counts (≤ 50 or > 50 cells/µL).
- see inclusion / non-inclusion for more information about eligibility.
- clinical sites
DATURA is registered in ClinicalTrials.gov : NCT04738812