INTENSE TBM
The INTENSE-TBM project aims to evaluate intensified tuberculosis treatment with or without aspirin in HIV-positive and HIV-negative individuals in order to improve the prognosis of tuberculosis in HIV-positive and HIV-negative patients living in sub-Saharan Africa. It is a randomized, controlled, …
Project Details
Principal Investigator
Hello, Frédéric Nogbou
Duration
55 months
Sponsor
ANRS
Objectives
Main Objectives
Secondary Objectives
In all patients with TBM,
Secondary objective 1: To evaluate the tolerability of intensified MT treatment during the first 2 months, with and without the addition of aspirin
Secondary objective 2: Compare disability in patients with MT at 12 months across the different arms
Secondary objective 3: Compare the time to hospital discharge across the different arms
Secondary objective 4: Measure the pharmacokinetics of antituberculosis drugs during the first month of MT
treatment Secondary objective 5: Assess the cost-effectiveness of the different interventions
Secondary Objective 6: Compare culture conversion rates across treatment arms
In HIV-infected patients with TBM, the following should be assessed
: Secondary Objective 1: the response to antiretroviral therapy in terms of virologic suppression, immunological response, and the incidence of opportunistic
infections Secondary objective 2: the frequency of immune reconstitution syndromes (IRS) in HIV-infected
individuals Secondary objective 3: the effect of increasing the rifampin dose on the pharmacokinetics of dolutegravir
Description & Context
The INTENSE-TBM project aims to evaluate intensified tuberculosis treatment with or without aspirin in HIV-positive and HIV-negative individuals in order to improve the prognosis of tuberculosis in HIV-positive and HIV-negative patients living in sub-Saharan Africa. It is a randomized, controlled, multicenter superiority trial that will be conducted in four countries (Côte d’Ivoire, Uganda, South Africa, and Madagascar).
Study Criteria
Inclusion
In all patients with MT (HIV-positive or HIV-negative)
Secondary endpoint 1: Incidence of death or loss to follow-up
Secondary endpoint 2: Serious adverse events, Grade 3 or 4; events of interest (central or peripheral nervous system, hematologic, hepatic toxicity)
Secondary endpoint 3: Percentage of patients at 12 months with successful tuberculosis treatment (WHO criteria)
Secondary outcome measure 4: Percentage of patients with disability
Inclusion criterion 1: age > 15 years
Inclusion criterion 2: possible, probable, or confirmed
tuberculous meningitis Inclusion criterion 3: tuberculosis associated with meningoencephalitis
Inclusion criterion 4: signed
informed consent form
Exclusion
Exclusion criterion 1: Creatinine clearance < 30 mL/min
Exclusion criterion 2: Decompensated
cirrhosis Exclusion criterion 3: ALT > 5 times the normal
value Exclusion criterion 4: Grade 4 laboratory abnormality
Research Team
The research team has not yet been filled in for this project.
Collaborate with us
We are open to partnerships with international research institutions and doctoral students.
Estimated response time: 3-5 business days.
