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Taking peoplePhase 2

Adalimumab Added to Standard Care for HIV-Linked Tuberculous Meningitis

Tests adalimumab alongside standard treatment in adults with HIV and tuberculous meningitis.

Plain-language title generated from the registry record
Registry title: Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis

Key facts

Where
Lusaka, ZambiaSee the site
Phase
Phase 2

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults living with HIV-1 who have tuberculosis meningitis (TB infection of the membranes around the brain) and started standard TB treatment in the last 3 days.

Age
18 years or older
Sex
All sexes
Disease stage
Definite or probable tuberculosis meningitis, together with HIV-1 infection.
Earlier treatment
Must have had standard tuberculosis meningitis treatment for 3 days or less: anti-TB drugs at standard doses and high-dose dexamethasone, as per WHO guidelines. People with a history of earlier TB treatment cannot join if the GeneXpert MTB/RIF Ultra test is negative or not available.
Biomarker or test result
HIV-1 infection. Rifampicin-resistant TB found by GeneXpert MTB/RIF Ultra rules a person out.

Main reasons for not taking part

  • Another infection of the nervous system, such as toxoplasmosis, cryptococcosis or bacterial meningitis
  • Hepatitis B (HBsAg) or hepatitis C antibodies positive
  • ALT liver test more than 5 times the upper limit of normal
  • Moderate to severe heart failure (NYHA classes III / IV)
  • Pregnancy or breastfeeding

This trial only enrols participants living with HIV. The registry sentence this rests on: HIV-1 infection

Read by machine on 9 November 2026.

Where in Zambia

  • Adult Infectious Diseases Centre, University Teaching HospitalLusaka, ZambiaNot yet recruiting

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

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.

ClinicalTrials.gov NCT05590455