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Clinical Trials in Brazil / NCT05590455
Recruiting Phase 2

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

NCT05590455 · tracked via the Priya Life Science Brazil tracker
Phase
Phase 2
Started
2023-04-11
Last updated
2025-12-15

Condition(s) studied

Tuberculous MeningitisHIV I Infection

Investigational drug(s) / intervention(s)

Adalimumab Injection →

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Laboratory of clinical research on STD/AIDS - IPEC/FIOCRUZ Rio de Janeiro Brazil Recruiting
Instituto Nacional de Saude Maputo Mozambique Not Yet Recruiting
Adult Infectious Diseases Centre, University Teaching Hospital Lusaka Zambia Not Yet Recruiting

More ANRS, Emerging Infectious Diseases trials in Brazil

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05590455 on ClinicalTrials.gov ↗ ← All trials in Brazil