ANRS DATURA study

Determining appropriate treatment for tuberculosis in hospitalised adults and adolescents with severe HIV-associated immune suppression

Published on 11 June 2024

In brief

Principal investigators
Didier Laureillard, UMR1058 – PCCI, Montpellier, Department of Infectious and Tropical Diseases, Nîmes University Hospital
François-Xavier BLANC, Pneumology Department, CHU Nantes, Laënnec Hospital, Nantes

Status
In progress

Pathologies
HIV, tuberculosis

Sponsorship
Inserm/ANRS MIE

The project

Tuberculosis and HIV: what are the risks?

In people with severe immunodepression associated with HIV (CD4 ≤ 100 cells/ μL), the incidence of tuberculosis is high and represents the most frequent cause of hospitalisation and death. Trials are currently underway to examine whether intensification of TB treatment can reduce the high mortality rate observed in these hospitalised patients.

What is the aim of the study?

The aim is to study an intervention combining increased doses of antibiotics (rifampicin and isoniazid) with a corticosteroid (prednisone).

Which patients can take part?

Patients must be 15 years of age or older and have HIV-1 infection with a CD4 lymphocyte count ≤ 100 /μL. They must be hospitalised for newly diagnosed tuberculosis.

What are the expected results?

The study will assess the impact of this treatment on mortality at 48 weeks in HIV-infected adults and adolescents hospitalised with tuberculosis. Other secondary endpoints will include mortality at 8 and 24 weeks, tolerability of treatment, success of tuberculosis treatment and response to antiretroviral treatment.

What is the schedule?

Participants are currently being recruited in five African countries (Cameroon, Guinea, Uganda, Zambia and Mozambique) and one South-East Asian country (Cambodia).