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

RecruitingPhase 2

Sponsor: ANRS, Emerging Infectious Diseases

Conditions: Tuberculous Meningitis, HIV I Infection

Interventions: Adalimumab Injection

Countries: Brazil, Mozambique, Zambia

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (3)

Rio de Janeiro, Brazil
Maputo, Mozambique
Lusaka, Zambia