NCT05590455RecruitingPhase 2
Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis
ANRS 12404 TIMPANI: Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis: a Phase II, Multicenter, Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 15 Dec 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 23 Nov 2021
- Start date
- 11 Apr 2023
- Primary completion date
- Jun 2027
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Diseases
- Tuberculosis, HIV
- NCT number
- NCT05590455
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 130
- From 11 Apr 2023 to the primary completion date, Jun 2027
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other concomitant neurological infection, i.e. toxoplasmosis, cryptococcosis, progressive multifocal leukoencephalopathy, bacterial meningitis, neuro-syphilis
- 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
- Subjects participating in another clinical trial evaluating therapies and including an exclusion period that is still in force during the screening phase
Other illness
- HBsAg positive or anti hepatitis C virus antibodies positive
- 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
Lab values
- Asymptomatic positive cryptococcal antigen in serum
- Alanine transaminase (ALT)\>5 ULN
Age
- For women of childbearing age: 1) Pregnancy or breastfeeding; 2) Refusal to use effective contraception to be discussed with the investigator
Other
- Rifampicin-resistant TB detected by GeneXpert MTB/RIF Ultra
- Person under guardianship, or deprived of freedom by a judicial or administrative decision
Who the study is looking for
- 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
- Signed informed consent form by patient or relative.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Laboratory of clinical research on STD/AIDS - IPEC/FIOCRUZ Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Recruiting |
| Instituto Nacional de Saude Coordinator of this site? Confirm its status | Maputo | Mozambique | Not yet recruiting |
| Adult Infectious Diseases Centre, University Teaching Hospital Coordinator of this site? Confirm its status | Lusaka | Zambia | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.