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:
- Any positive Xpert® MTB/RIF specimen (sputum, urine, pus, other),
- Or a positive urine lipoarabinomannan (LAM) test,
- Or an abnormal chest X-ray compatible with active TB
Non-inclusion criteria:
- Initiation of TB drugs for more than 7 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
- Currently treated with ART regimen containing protease inhibitors
- Any contraindication to efavirenz and dolutegravir
- Severe associated diseases requiring corticosteroids of for which corticosteroids are contra-indicated
- Impaired hepatic function with ALT (SGPT) > 5 times the upper limit of normal (ULN) value
- Creatinine clearance < 30 mL/min (according to either the MDRD or the CKD-EPI formula)
- Pregnancy or breastfeeding
DATURA is registered in ClinicalTrials.gov : NCT04738812