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 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 ClinicalTrials.gov : NCT04738812