Using adalimumab to improve survival in HIV patients with tuberculosis meningitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial evaluates the effect of adding adalimumab, a tumor necrosis factor inhibitor, to the standard treatment regimen for HIV-infected adults diagnosed with tuberculosis meningitis. Participants will be randomized to receive either standard treatment with anti-tuberculosis drugs and corticosteroids or the same treatment plus adalimumab. The trial aims to assess the impact on 3-month mortality and safety across three countries: Brazil, Mozambique, and Zambia. The study will also monitor the initial severity of the condition using the British Medical Research Council score to stratify randomization.

Why it matters

Who can join: the full rules

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

Where it's running

• Laboratory of clinical research on STD/AIDS - IPEC/FIOCRUZ
  Rio de Janeiro, Brazil Recruiting
• Instituto Nacional de Saude
  Maputo, Mozambique Not yet recruiting
• Adult Infectious Diseases Centre, University Teaching Hospital
  Lusaka, Zambia Not yet recruiting

Study contacts

• Principal investigator: Nathalie DE CASTRO, MD — AP-HP, Hôpital Saint-Louis
• Study coordinator: Vanessa MACHAULT, PhD
• Email: vanessa.machault@u-bordeaux.fr
• Phone: +335 57 57 57 63

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.