RecruitingPhase 2NCT05590455

Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis

ANRS 12404 TIMPANI: Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis: a Phase II, Multicenter, Randomized Clinical Trial


Sponsor

ANRS, Emerging Infectious Diseases

Enrollment

130 participants

Start Date

Apr 11, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a class of drugs called TNF inhibitors (which dampen inflammation) can reduce deaths in HIV-positive patients with tuberculosis meningitis — a severe infection of the fluid and membranes around the brain. Current treatment with antibiotics and steroids still leaves many patients at risk. **You may be eligible if...** - You are 18 years or older - You are HIV-positive - You have a confirmed or probable diagnosis of tuberculosis meningitis - You started standard TB treatment (antibiotics and high-dose steroids) within the last 3 days **You may NOT be eligible if...** - You have another brain infection (like toxoplasmosis, cryptococcal meningitis, or bacterial meningitis) - You have active hepatitis B or C - Your liver enzymes are severely elevated - Your TB is resistant to rifampicin (a key antibiotic) - You have had TB meningitis before Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdalimumab 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

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NCT05590455


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