Determination of Adequate Tuberculosis Regimen in Patients Hospitalized With HIV-associated Severe Immune Suppression
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- HIV -1 Infection
- Immuno-Deficiency
- Tuberculosis
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: DATURA trial is a phase III, multicenter, two-arm, open-label, randomized superiority trial.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 15 years and 125 years
- Gender
- Both males and females
Description
Settings: 4 African (Cameroon, Guinea, Uganda, Zambia) and 2 South-East Asian (Cambodia, Vietnam) countries. Sample size : 1330 patients (665 in each arm). Follow-up : 48 weeks after entry in the trial (TB treatment initiation). All participants will initiate antiretroviral therapy (ART) 2 weeks aft...
Settings: 4 African (Cameroon, Guinea, Uganda, Zambia) and 2 South-East Asian (Cambodia, Vietnam) countries. Sample size : 1330 patients (665 in each arm). Follow-up : 48 weeks after entry in the trial (TB treatment initiation). All participants will initiate antiretroviral therapy (ART) 2 weeks after starting TB treatment. In each country, the chosen ART regimen will be the same in both arms. According to the first-line regimen recommended in each country, the ART combination will be TDF/3TC/EFV 600 mg, or TDF/3TC + double-dose DTG. The primary objective is to estimate the impact of an intensified initial phase of TB treatment on mortality at 48 weeks among HIV-infected adults and adolescents hospitalized for TB with CD4 ? 100 cells/?L in comparison with standard TB treatment. The secondary objectives are to estimate the impact of an intensified initial phase of TB treatment, in comparison with the standard TB regimen, on: Mortality at weeks 8 and 24 Adverse events, including All grade 3 and 4 events Selected grade 2 events of interest Drug-related adverse events AIDS-defining illnesses Paradoxical TB-associated immune reconstitution inflammatory syndrome (IRIS) TB treatment success TB recurrence ART response in terms of virological success and immunological response Adherence to TB treatment and ART Peak plasma concentrations of rifampicin and isoniazid (and its N-acetyl-metabolite) at day 3, day 7 and week 2 Plasma concentrations of efavirenz and dolutegravir at week 4 (i.e. 2 weeks after the onset of ART). A pharmacokinetic sub-study of rifampicin and isoniazid will be carried out in 72 voluntary patients (6 patients/arm/country) at the second week of the main study.
Tracking Information
- NCT #
- NCT04738812
- Collaborators
- European Union
- European and Developing Countries Clinical Trials Partnership (EDCTP)
- Investigators
- Principal Investigator: BLANC François-Xavier, MD, PhD University Hospital of Nantes, France Principal Investigator: LAUREILLARD Didier, MD University Hospital of Nimes, France
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