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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥18 years - HIV-1 infection - Definite or probable tuberculosis meningitis - Standard tuberculosis meningitis treatment ≤3 days: anti TB drugs at standard doses and high-dose dexamethasone as per WHO guidelines - Signed willing to sign a consent form form by patient or relative. Who Should NOT Join This Trial: - Other concomitant neurological infection, i.e. toxoplasmosis, cryptococcosis, progressive multifocal leukoencephalopathy, bacterial meningitis, neuro-syphilis - Asymptomatic positive cryptococcal antigen in serum - HBsAg positive or anti hepatitis C virus antibodies positive - Alanine transaminase (ALT)\>5 ULN - Rifampicin-resistant TB detected by GeneXpert MTB/RIF Ultra - History of previous TB treatment in patients with GeneXpert MTB/RIF Ultra negative or unavailable - Current use of drugs contraindicated with study drugs and that cannot be safely stopped - Allergy to study drugs or any of their components - Uncontrolled opportunistic infection - Moderate to severe cardiac insufficiency (NYHA classes III / IV) - Any condition which might, in the investigator's opinion, compromise the safety of treatment and/or patient's adherence to study procedures - For women of childbearing age: 1) Pregnancy or breastfeeding; 2) Refusal to use effective contraception to be discussed with the investigator - Subjects participating in another clinical trial evaluating therapies and including an exclusion period that is still in force during the screening phase - Person under guardianship, or deprived of freedom by a judicial or administrative decision Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Age ≥18 years * HIV-1 infection * Definite or probable tuberculosis meningitis * Standard tuberculosis meningitis treatment ≤3 days: anti TB drugs at standard doses and high-dose dexamethasone as per WHO guidelines * Signed informed consent form by patient or relative. Exclusion Criteria: * Other concomitant neurological infection, i.e. toxoplasmosis, cryptococcosis, progressive multifocal leukoencephalopathy, bacterial meningitis, neuro-syphilis * Asymptomatic positive cryptococcal antigen in serum * HBsAg positive or anti hepatitis C virus antibodies positive * Alanine transaminase (ALT)\>5 ULN * Rifampicin-resistant TB detected by GeneXpert MTB/RIF Ultra * History of previous TB treatment in patients with GeneXpert MTB/RIF Ultra negative or unavailable * Current use of drugs contraindicated with study drugs and that cannot be safely stopped * Allergy to study drugs or any of their components * Uncontrolled opportunistic infection * Moderate to severe cardiac insufficiency (NYHA classes III / IV) * Any condition which might, in the investigator's opinion, compromise the safety of treatment and/or patient's adherence to study procedures * For women of childbearing age: 1) Pregnancy or breastfeeding; 2) Refusal to use effective contraception to be discussed with the investigator * Subjects participating in another clinical trial evaluating therapies and including an exclusion period that is still in force during the screening phase * Person under guardianship, or deprived of freedom by a judicial or administrative decision

Treatments Being Tested

DRUG

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