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.
Who can participate
Age range
15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
INCLUSION CRITERIA
* Patient (and legally designed representative of minor patient) able to correctly understand the trial and to sign the informed consent
* Aged ≥ 15 years
* Confirmed HIV-1 infection as documented at any time prior to trial entry per national HIV testing procedures
* CD4 count ≤ 100 cells/μL
* Hospitalized for a newly diagnosed TB, defined by:
* Any positive Xpert® MTB/RIF specimen (sputum, urine, pus, other),
* Or a positive urine lipoarabinomannan (LAM) test,
* Or an abnormal chest X-ray compatible with active TB
EXCLUSION CRITERA
* Initiation of TB drugs for more than 7 days
* History of TB treatment during the last 6 months
* Central neurological symptoms, including but not restrictive to TB meningitis
* Suspected TB pericarditis
* Documented Mycobacterium tuberculosis strain resistant to rifampicin using rapid molecular testing (Xpert® MTB/RIF)
* Any concomitant medication or known hypersensitivity contraindicating any component of the TB treatment
* HIV-2 co-infection
* Current treatment with ART containing protease inhibitors
* Any contraindication to efavirenz and dolutegravir
* Severe associated diseases requiring corticosteroids or for which corticosteroids are contra-indicated
* Impaired hepatic function with ALT (SGPT) \> 5 times the upper limit of normal (ULN) value
* Creatinine clearance \< 30 mL/min/1.73m2 (according to either the MDRD or the CKD-EPI formula)
* Pregnancy or breastfeeding
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.