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

CompletedPhase 3

Sponsor: ANRS, Emerging Infectious Diseases

Conditions: Tuberculosis, HIV-1-infection, Immuno-Deficiency

Interventions: Intensified TB treatment (initial phase), WHO standard TB treatment (initial phase)

Countries: Cambodia, Cameroon, Guinea, Mozambique, Uganda, Zambia

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.

Eligibility overview

Sex: ALL

Age: 15 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (6)

Phnom Penh, Cambodia
Yaoundé, Cameroon
Conakry, Guinea
Maputo, Mozambique
Mbarara, Uganda
Lusaka, Zambia