ANRS 12404 TIMPANI: Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis: a Phase II, Multicenter, Randomized Clinical Trial
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Brazil
Laboratory of clinical research on STD/AIDS - IPEC/FIOCRUZ
RECRUITING
Rio De Janeiro
Mozambique
Instituto Nacional de Saude
NOT_YET_RECRUITING
Maputo
Zambia
Adult Infectious Diseases Centre, University Teaching Hospital
NOT_YET_RECRUITING
Lusaka
Contact Information
Primary
Vanessa MACHAULT, PhD
vanessa.machault@u-bordeaux.fr
+335 57 57 57 63
Backup
Olivier MARCY, MD PhD
Time Frame
Start Date: 2023-04-11
Estimated Completion Date: 2027-06
Participants
Target number of participants: 130
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: ANRS, Emerging Infectious Diseases