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

Sponsor
ANRS, Emerging Infectious Diseases
Study ID
NCT05590455
Phase
PHASE2
Status
Recruiting
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Conditions

  • HIV I Infection
  • Tuberculous Meningitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab Injection — DRUG
    one sub-cutaneous injection, every 2 weeks for 10 weeks (total 6 injections), started as soon as possible during the first 3 days of antituberculosis treatment and high-dose steroids

Study Details

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).

Key Dates

Start date
Apr 11, 2023
Status verified
Dec 2025
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Adalimumab arm
    * Standard TBM treatment * Adalimumab 40 mg: one sub-cutaneous injection, every 2 weeks for 10 weeks (total 6 injections), started as soon as possible during the first 3 days of antituberculosis treatment and high-dose steroids
  • No Intervention: Control arm
    \- Standard TBM

Primary Outcome Measure

3-month all-cause mortality [ Time Frame: 3 months ]

Central Contacts

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