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Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis
Sponsor: ANRS, Emerging Infectious Diseases
Summary
Randomized phase II clinical trial which aims to assess the impact on 3-month mortality and safety of adding adalimumab to standard treatment (anti-tuberculosis drugs and corticosteroids) in HIV patients with tuberculosis meningitis in 3 countries (Brazil, Mozambique, and Zambia).
Official title: ANRS 12404 TIMPANI: Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis: a Phase II, Multicenter, Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2023-04-11
Completion Date
2027-12
Last Updated
2025-12-15
Healthy Volunteers
No
Conditions
Interventions
Adalimumab Injection
one sub-cutaneous injection, every 2 weeks for 10 weeks (total 6 injections), started as soon as possible during the first 3 days of antituberculosis treatment and high-dose steroids
Locations (3)
Laboratory of clinical research on STD/AIDS - IPEC/FIOCRUZ
Rio de Janeiro, Brazil
Instituto Nacional de Saude
Maputo, Mozambique
Adult Infectious Diseases Centre, University Teaching Hospital
Lusaka, Zambia