Status:
COMPLETED
Determination of Adequate Tuberculosis Regimen in Patients Hospitalized With HIV-associated Severe Immune Suppression
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
European Union
European and Developing Countries Clinical Trials Partnership (EDCTP)
Conditions:
Tuberculosis
HIV-1-infection
Eligibility:
All Genders
15+ years
Phase:
PHASE3
Brief Summary
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 treatm...
Detailed Description
Settings: 5 African (Cameroon, Guinea, Uganda, Zambia, Mozambique) and 1 South-East Asian (Cambodia) countries. Sample size : 1330 patients (665 in each arm). Follow-up : 48 weeks after entry in the ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- 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
Exclusion
Key Trial Info
Start Date :
April 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2025
Estimated Enrollment :
1330 Patients enrolled
Trial Details
Trial ID
NCT04738812
Start Date
April 21 2022
End Date
November 12 2025
Last Update
December 22 2025
Active Locations (6)
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1
National Center for HIV/AIDS, Dermatology and STD (NCHADS)
Phnom Penh, Cambodia
2
Jamot Hospital
Yaoundé, Cameroon
3
Ignace Deen Hospital
Conakry, Guinea
4
MACHAVA Hospital
Maputo, Mozambique