drugset / Trial / NCT04738812
Determination of Adequate Tuberculosis Regimen in Patients Hospitalized With HIV-associated Severe Immune Suppression
Phase 3
Completed
1330 enrolled
ANRS, Emerging Infectious Diseases
European Union · collabEuropean and Developing Countries Clinical Trials Partnership (EDCTP) · collab
RandomizedParallel-groupOpen-labelTreatment
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 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.
Timeline
- Start
- 2022-04-21
- Primary completion
- 2025-11-12
- Completion
- 2025-11-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Albendazole | Small molecule | 400 mg | — |
| Subject | Ethambutol | Small molecule | — | — |
| Subject | Isoniazid | Small molecule | 10 mg/kg | — |
| Subject | Prednisone | Other / unclassified | — | — |
| Subject | Pyrazinamide | Small molecule | — | — |
| Subject | Rifampicin | Small molecule | 35 mg/kg | — |