NCT05590455 Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis
| NCT ID | NCT05590455 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | ANRS, Emerging Infectious Diseases |
| Condition | Tuberculous Meningitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2023-04-11 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 130 participants in total. It began in 2023-04-11 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Nathalie DE CASTRO, MD
PRINCIPAL INVESTIGATOR
AP-HP, Hôpital Saint-Louis
Frequently Asked Questions
Who can join the NCT05590455 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tuberculous Meningitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05590455 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05590455 currently recruiting?
Yes, NCT05590455 is actively recruiting participants. Contact the research team at vanessa.machault@u-bordeaux.fr for enrollment information.
Where is the NCT05590455 trial being conducted?
This trial is being conducted at Rio de Janeiro, Brazil, Maputo, Mozambique, Lusaka, Zambia.
Who is sponsoring the NCT05590455 clinical trial?
NCT05590455 is sponsored by ANRS, Emerging Infectious Diseases. The principal investigator is Nathalie DE CASTRO, MD at AP-HP, Hôpital Saint-Louis. The trial plans to enroll 130 participants.