Inclusion / non-inclusion criteria

Inclusion criteria:

  • Patient (and legally designed representatives of minor patients) able to correctly understand the trial and to sign the informed consent
  • Aged ≥ 15 years
  • Confirmed HIV-1 infection as documented at any time prior to trial entry per national HIV testing procedures
  • CD4 count ≤ 100 cells/μL
  • Hospitalised for a newly diagnosed TB, defined by:
  1. Any positive Xpert® MTB/RIF specimen (sputum, urine, pus, other),
  2. Or a positive urine lipoarabinomannan (LAM) test,
  3. Or an abnormal chest X-ray compatible with active TB

Non-inclusion criteria:

  • Initiation of TB drugs for more than 3 days
  • History of TB treatment during the last 6 months
  • Central neurological system TB, including but not restrictive to TB meningitis
  • Suspected TB pericarditis
  • Documented Mycobacterium tuberculosis strain resistant to rifampicin using rapid molecular testing (Xpert® MTB/RIF)
  • Any concomitant medication or known hypersensitivity contraindicating any component of the TB treatment
  • HIV-2 co-infection
  • History of ART, unless if stopped for more than 1 year
  • Currently treated with ART for more than 1 week
  • Any contraindication to efavirenz and dolutegravir
  • Severe associated diseases requiring specific treatment (including all specific AIDS defining illnesses other than TB and any severe sepsis)
  • Impaired hepatic function with ALT (SGPT) > 5 times the upper limit of normal (ULN) value
  • Creatinine clearance < 50 mL/min (according to the Cockcroft-Gault formula)
  • Pregnancy or breastfeeding

DATURA is registered in : NCT04738812