ANRS DATURA : A new study to reduce the mortality of immunosuppressed People Living with HIV and infected with tuberculosis

11 May 2022
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ANRS DATURA – Determination of Adequate Tuberculosis Regimen in Adults and adolescents hospitalised with HIV-associated severe immune suppression – co-funded by ANRS | Emerging Infectious Diseases and the European and Developing Countries Clinical Trials Partnership (EDCTP2) – is an international clinical trial evaluating the efficacy of intensified tuberculosis treatment on tuberculosis mortality in immunosuppressed individuals, namely hospitalized HIV-infected adults and adolescents. This three-year project, involving 24 months of inclusion and 12 months of follow-up, has been implemented in six countries of sub-Saharan Africa and South-East Asia: Cambodia, Cameroon, Guinea, Uganda, Vietnam, and Zambia. 

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The HIV/AIDS and tuberculosis epidemics are very strongly linked and represent major challenges to global public health. At the end of 2020, the World Health Organization (WHO) estimated that there are 37.7 million people living with HIV – over 90% of whom in resource-limited countries*. 

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Despite mortality rates for AIDS-related diseases having fallen by 44% between 2010 and 2018 in eastern and southern Africa, and by 39% in Asia and the Pacific, tuberculosis remains the leading cause of death among people living with HIV (PLHIV), accounting for around one in three deaths in this population.

The primary objective of the ANRS DATURA Phase III trial is to evaluate, 48 weeks after inclusion of the participants, the efficacy and safety of an intensified tuberculosis treatment regimen with higher doses of rifampicin and isoniazid in relation to WHO standard of care, with the addition of systemic corticosteroids during the initial treatment phase. The 1330 patients included in the trial will be HIV-infected (CD4 ≤ 100 cells/μL) adults and adolescents aged 15 or older and hospitalized for tuberculosis. This will make it possible to determine the impact of this treatment on the patient mortality rate and compare it with the standard regimen currently recommended by the WHO. 

Although the COVID-19 pandemic had heavily impacted and delayed the deployment of the project, ANRS DATURA was able to begin patient recruitment in April 2022. Its first participant was included at the Ignace Deen Hospital in Conakry, Guinea on April 21, 2022. 

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"We have high expectations for this research project because the mortality rate for tuberculosis among people living with HIV remains very high, reaching 30% in highly immunosuppressed patients. In Guinea, the tuberculosis mortality rate has declined considerably, with the exception of HIV-infected patients. That is why we hope that DATURA will be able to provide answers to the causes of this high mortality and enable the development of more appropriate treatment approaches."

Dr. Boubacar Djelo Diallo, principal investigator of the DATURA project in Guinea.  

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List of the ANRS DATURA project partner institutions :

• French National Institute of Health and Medical Research, Inserm (JRU 1058), Montpellier, France
• Nantes University Hospital, France
• Research Institute for Sustainable Development (IRD), France
• Doctors Without Borders – Epicentre, France
• University of Bergen, Norway
• Mbarara University of Science and Technology, Uganda
• University Teaching Hospital, Lusaka, Zambia
• Ignace Deen National Hospital, Conakry, Guinea
• Central Hospital of Yaoundé, Cameroon
• Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam
• Pasteur Institute of Cambodia, Phnom Penh, Cambodia
• National Centre for HIV/AIDS Dermatology and STDs, Phnom Penh, Cambodia

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For more information, visit : 

DATURA project website : https://datura.w.uib.no/ 

ClinicalTrials.gov : https://clinicaltrials.gov/ct2/show/NCT04738812?term=NCT04738812&draw=2&rank=1 

World TB Day 2022 : the agency's actions to support research : https://www.anrs.fr/fr/actualites/1033/journee-mondiale-de-lutte-contre-la-tuberculose-2022-les-actions-de-lagence-pour

Press contact :

Communication and Scientific Information Department : information@anrs.fr