Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis

Launched by ANRS, EMERGING INFECTIOUS DISEASES · Oct 18, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether adding a medication called adalimumab to the usual treatment for tuberculosis meningitis can help reduce the risk of death in people living with HIV. The trial is taking place in Brazil, Mozambique, and Zambia and involves patients who are at least 18 years old and have recently been diagnosed with tuberculosis meningitis. To participate, they should not have been on HIV treatment for at least six months, and they must be starting their tuberculosis treatment (including specific anti-tuberculosis drugs and steroids) within the last three days.

Participants in this trial will receive either the standard treatment or the standard treatment plus adalimumab, and doctors will carefully monitor their health over three months. It’s important for potential participants to know that certain health conditions may prevent them from joining the study, such as having other serious infections or specific heart problems. Those interested will need to sign a consent form, confirming they understand the trial and agree to participate. This trial aims to find out if the added medication can improve survival rates for those facing this challenging illness.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years
• • HIV-1 infection
• • ART-naïve or ART discontinued for at least 6 months
• • 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
• • HIV-2 infection (single or dual)
• • 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
• • Positive SARS COV-2 test (according to hospital procedures at the time of inclusion)