Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis
Key facts
- Where
- Lusaka, ZambiaSee the site
- Phase
- Phase 2
Where in Zambia
- Adult Infectious Diseases Centre, University Teaching HospitalLusaka, ZambiaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- ANRS, Emerging Infectious Diseases
- Trial code
- NCT05590455
- Record updated
- 15 December 2025
- Original description
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).Read full original descriptionShow less
ANRS 12404 TIMPANI: Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis: a Phase II, Multicenter, Randomized Clinical 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).
Inclusion: 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: Other concomitant neurological infection, i.e. toxoplasmosis, cryptococcosis, progressive multifocal leukoencephalopathy, bacterial meningitis, neuro-syphilis; 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; Subjects participating in another clinical trial evaluating therapies and including an exclusion period that is still in force during the screening phase; HBsAg positive or anti hepatitis C virus antibodies positive; 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; Asymptomatic positive cryptococcal antigen in serum; Alanine transaminase (ALT)>5 ULN; For women of childbearing age: 1) Pregnancy or breastfeeding; 2) Refusal to use effective contraception to be discussed with the investigator; Rifampicin-resistant TB detected by GeneXpert MTB/RIF Ultra; Person under guardianship, or deprived of freedom by a judicial or administrative decision.