Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorANRS, Emerging Infectious Diseases
About this 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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Adalimumab Injection
Treatment groups
130 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov