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RECRUITING
NCT05590455
PHASE2

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

Sponsor: ANRS, Emerging Infectious Diseases

View on ClinicalTrials.gov

Summary

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).

Official title: ANRS 12404 TIMPANI: Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis: a Phase II, Multicenter, Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2023-04-11

Completion Date

2027-12

Last Updated

2025-12-15

Healthy Volunteers

No

Interventions

DRUG

Adalimumab Injection

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

Locations (3)

Laboratory of clinical research on STD/AIDS - IPEC/FIOCRUZ

Rio de Janeiro, Brazil

Instituto Nacional de Saude

Maputo, Mozambique

Adult Infectious Diseases Centre, University Teaching Hospital

Lusaka, Zambia