Could an arthritis drug save lives from a deadly brain infection?
NCT ID NCT05590455
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether adding adalimumab (an arthritis drug) to standard tuberculosis meningitis treatment can reduce deaths in HIV-positive adults. About 130 participants in Brazil, Mozambique, and Zambia will receive adalimumab injections every two weeks for 10 weeks alongside anti-TB drugs and steroids. The study focuses on survival at three months and monitors for serious infections and side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- adalimumab (a TNF inhibitor injection)
- What this could lead to
- If it works, this could point toward a new treatment that lowers the high death rate from tuberculosis meningitis in people with HIV.
- What could go wrong
- This is a small, early-phase trial (130 participants) testing safety and effectiveness. Adding a strong immune-suppressing drug may increase the risk of serious infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Adult Infectious Diseases Centre, University Teaching Hospital
NOT_YET_RECRUITINGLusaka, Zambia
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Instituto Nacional de Saude
NOT_YET_RECRUITINGMaputo, Mozambique
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Laboratory of clinical research on STD/AIDS - IPEC/FIOCRUZ
RECRUITINGRio de Janeiro, 21040-900, Brazil
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Long-acting HIV shot studied in patients with severe kidney problems
- Could a drug cocktail slash deaths from TB of the brain?
- HIV cocktail aims to free patients from daily pills
- New TB vaccine candidate MTBVAC enters key safety trial in south africa
- Could a 6-Month drug cocktail beat 9 months for brain TB?