Actively Recruiting
Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis
Led by ANRS, Emerging Infectious Diseases · Updated on 2025-12-15
130
Participants Needed
3
Research Sites
242 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- HIV-1 infection
- Definite or probable tuberculosis meningitis
- Standard tuberculosis meningitis treatment for 3 days or less, including anti-TB drugs at standard doses and high-dose dexamethasone as per WHO guidelines
- Signed informed consent form by patient or relative.
You will not qualify if you...
- Other neurological infections such as toxoplasmosis, cryptococcosis, progressive multifocal leukoencephalopathy, bacterial meningitis, or neuro-syphilis
- Asymptomatic positive cryptococcal antigen in serum
- Positive for hepatitis B surface antigen or hepatitis C antibodies
- Alanine transaminase (ALT) greater than 5 times the upper limit of normal
- Rifampicin-resistant tuberculosis detected by GeneXpert MTB/RIF Ultra
- History of previous tuberculosis treatment if GeneXpert MTB/RIF Ultra is negative or unavailable
- Current use of drugs that cannot be safely stopped and are contraindicated with study drugs
- Allergy to study drugs or any of their components
- Uncontrolled opportunistic infection
- Moderate to severe heart failure (NYHA classes III or IV)
- Any condition that may compromise safety or adherence to study procedures
- For women of childbearing age: pregnancy, breastfeeding, or refusal to use effective contraception
- Participation in another clinical trial with an exclusion period still active during screening
- Being under guardianship or deprived of freedom by a judicial or administrative decision
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Laboratory of clinical research on STD/AIDS - IPEC/FIOCRUZ
Rio de Janeiro, Brazil, 21040-900
Actively Recruiting
2
Instituto Nacional de Saude
Maputo, Mozambique
Not Yet Recruiting
3
Adult Infectious Diseases Centre, University Teaching Hospital
Lusaka, Zambia
Not Yet Recruiting
Research Team
V
Vanessa MACHAULT, PhD
CONTACT
O
Olivier MARCY, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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