Determination of Adequate Tuberculosis Regimen in Patients Hospitalized With HIV-associated Severe Immune Suppression (DATURA)

  • STATUS
    Recruiting
  • End date
    Mar 11, 2025
  • participants needed
    1330
  • sponsor
    ANRS, Emerging Infectious Diseases
Updated on 11 May 2022

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 IdentifierNCT04738812
SponsorANRS, Emerging Infectious Diseases
Last Modified on11 May 2022

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