Determination of Adequate Tuberculosis Regimen in Patients Hospitalized With HIV-associated Severe Immune Suppression (DATURA)
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- STATUS
- Recruiting
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- End date
- Mar 11, 2025
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- participants needed
- 1330
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- sponsor
- ANRS, Emerging Infectious Diseases
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.
Description
Settings: 4 African (Cameroon, Guinea, Uganda, Zambia) and 2 South-East Asian (Cambodia, Vietnam) countries.
Sample size : 1330 patients (665 in each arm). Follow-up : 48 weeks after entry in the trial (TB treatment initiation).
All participants will initiate antiretroviral therapy (ART) 2 weeks after starting TB treatment. In each country, the chosen ART regimen will be the same in both arms. According to the first-line regimen recommended in each country, the ART combination will be TDF/3TC/EFV 600 mg, or TDF/3TC + double-dose DTG.
The primary objective is to estimate the impact of an intensified initial phase of TB treatment on mortality at 48 weeks among HIV-infected adults and adolescents hospitalized for TB with CD4 ≤ 100 cells/μL in comparison with standard TB treatment.
The secondary objectives are to estimate the impact of an intensified initial phase of TB treatment, in comparison with the standard TB regimen, on:
- Mortality at weeks 8 and 24
- Adverse events, including
- All grade 3 and 4 events
- Selected grade 2 events of interest
- Drug-related adverse events
- AIDS-defining illnesses
- Paradoxical TB-associated immune reconstitution inflammatory syndrome (IRIS)
- TB treatment success
- TB recurrence
- ART response in terms of virological success and immunological response
- Adherence to TB treatment and ART
- Peak plasma concentrations of rifampicin and isoniazid (and its N-acetyl-metabolite) at day 3, day 7 and week 2
- Plasma concentrations of efavirenz and dolutegravir at week 4 (i.e. 2 weeks after the onset of ART).
A pharmacokinetic sub-study of rifampicin and isoniazid will be carried out in 72 voluntary patients (6 patients/arm/country) at the second week of the main study.
Details
| Condition | Tuberculosis, HIV-1-infection, Immuno-Deficiency |
|---|---|
| Treatment | Intensified TB treatment (initial phase), WHO standard TB treatment (initial phase) |
| Clinical Study Identifier | NCT04738812 |
| Sponsor | ANRS, Emerging Infectious Diseases |
| Last Modified on | 11 May 2022 |
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