NCT04738812CompletedPhase 3
Determination of Adequate Tuberculosis Regimen in Patients Hospitalized With HIV-associated Severe Immune Suppression
ANRS 12424: Determination of Adequate Tuberculosis Regimen in Adults and Adolescents Hospitalized With HIV-associated Severe Immune Suppression (CD4 ≤ 100 Cells/µL): the DATURA Trial.
Source: ClinicalTrials.gov · Last updated 22 Dec 2025
Brief summary (registry, in English)
DATURA trial is a phase III, multicenter, two-arm, open-label, randomized superiority trial to compare the efficacy and the safety of an intensified tuberculosis (TB) regimen versus standard TB treatment in HIV-infected adults and adolescents hospitalized for TB with CD4 ≤ 100 cells/μL over 48 weeks: * Intensified TB treatment regimen: increased doses of rifampicin and isoniazid together with standard-dose of pyrazinamide and ethambutol for 8 weeks in addition to prednisone for 6 weeks and albendazole for 3 days * WHO standard TB treatment regimen. The continuation phase of TB treatment will be identical in the two arms: 4 months of rifampicin and isoniazid at standard doses.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1330 (actual)
- First submitted
- 1 Feb 2021
- Start date
- 21 Apr 2022
- Primary completion date
- 12 Nov 2025
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Diseases
- Tuberculosis, HIV
- NCT number
- NCT04738812
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 1330
- From 21 Apr 2022 to the primary completion date, 12 Nov 2025
- 6 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Patient (and legally designed representative of minor patient) 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
- Hospitalized 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
- EXCLUSION CRITERA
- Initiation of TB drugs for more than 7 days
- History of TB treatment during the last 6 months
- Central neurological symptoms, 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
- Current treatment with ART containing protease inhibitors
- Any contraindication to efavirenz and dolutegravir
- Severe associated diseases requiring corticosteroids or 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/1.73m2 (according to either the MDRD or the CKD-EPI formula)
- Pregnancy or breastfeeding
Age in the registry: 15 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jamot Hospital Coordinator of this site? Confirm its status | Yaoundé | Cameroon | Unknown status |
| Ignace Deen Hospital Coordinator of this site? Confirm its status | Conakry | Guinea | Unknown status |
| National Center for HIV/AIDS, Dermatology and STD (NCHADS) Coordinator of this site? Confirm its status | Phnom Penh | Cambodia | Unknown status |
| MACHAVA Hospital Coordinator of this site? Confirm its status | Maputo | Mozambique | Unknown status |
| Mbarara Regional Referral Hospital Coordinator of this site? Confirm its status | Mbarara | Uganda | Unknown status |
| University Teaching Hospital Coordinator of this site? Confirm its status | Lusaka | Zambia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.