Trial Info – DATURA

DATURA is registered in ClinicalTrials.gov : NCT04738812

HIV-1 infected adults and adolescents hospitalised with active TB disease and not currently treated with ART for more than one week will be included in the trial and randomised between 2 arms.

Initial phase:

ARM 1 – the intensified TB treatment arm (increased doses of rifampicin and isoniazid together with standard-dose of pyrazinamide and ethambutol for 8 weeks in addition to prednisone for 6 weeks)
ARM 2 – the WHO standard TB treatment for 8 weeks.

The continuation phase of TB treatment will be identical in the two arms: 4 months of rifampicin and isoniazid at standard doses.

Patients will be followed-up for an additional 24 weeks (6 months) in the follow-up phase.

Learn more:

DATURA – a clinical trial

DATURA addresses people who are co-infected with TB and HIV. It is a research project that aims to assess whether an intensified initial TB treatment could increase survival in hospitalised, HIV-infected adults and adolescents compared to the standard TB treatment regime.

DATURA is registered in ClinicalTrials.gov : NCT04738812

Important DATURA dates:

Mozambique participated as a trial site by 2024, with first patient inclusion in February 15th, 2024
The European and Developing Countries Clinical Trials Partnership (EDCTP)signed the Grant 14 April 2020.
Official starting date of the project period is 1 May 2020. The project will last for 54 months from this date.
DATURA kick-off 14-15 Sept. 2020
First participant enrolled on April 21^st, 2022.
All African sites recruiting by August 2022.
EDCTP grant extended for an additional 14 months until December 2025.