Phase 2 Tuberculosis Trial, Recruiting NCT05590455 Sponsor: ANRS, Emerging Infectious Diseases Condition: Tuberculosis
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Phase 2 Tuberculosis Trial, Recruiting

NCT05590455
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 18 years of age or older
  • You are living with HIV-1 (a specific type of HIV)
  • You have been diagnosed with, or are strongly suspected to have, tuberculosis meningitis (TB affecting the brain and surrounding membranes)
  • You have been receiving standard treatment for tuberculosis meningitis for 3 days or fewer, including anti-TB medications and high-dose dexamethasone (a steroid), as recommended by the World Health Organization
  • You, or a family member on your behalf, are willing and able to sign a consent form agreeing to take part

Who may not be able to join:

  • You have another active infection affecting the brain or nervous system at the same time, such as toxoplasmosis, cryptococcal meningitis, bacterial meningitis, syphilis affecting the brain, or a condition called progressive multifocal leukoencephalopathy
  • You have tested positive for a fungal infection marker (cryptococcal antigen) in your blood, even without symptoms
  • You have tested positive for hepatitis B or hepatitis C
  • Your liver enzyme levels (a measure of liver health) are significantly raised above the normal range
  • Your TB has been found to be resistant to an antibiotic called rifampicin
  • You have been treated for TB before, and your current test either came back negative or was not available (confirm with trial site)
  • You are currently taking medications that would interact dangerously with the trial drugs and cannot safely be stopped
  • You have a known allergy to the trial drugs or any of their ingredients
  • You have an opportunistic infection (an illness that takes advantage of a weakened immune system) that is not currently under control
  • You have moderate to severe heart failure
  • You have any other health condition that, in the opinion of the medical team, could put your safety at risk or make it difficult to follow the study procedures
  • You are pregnant or breastfeeding, or if you are a woman who could become pregnant, you are not willing to use an effective form of contraception during the trial (to be discussed with the trial team)
  • You are currently taking part in another clinical trial that has a rule preventing you from joining additional trials
  • You are under legal guardianship, or your freedom is restricted by a legal or administrative order

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Nathalie DE CASTRO, MD, AP-HP, Hôpital Saint-Louis

Phone: +335 57 57 57 63

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
ANRS, Emerging Infectious Diseases
Registry
ClinicalTrials.gov
Start date
11 April 2023
Est. completion
1 June 2027

Where this trial is recruiting

🇧🇷 Brazil Mozambique Zambia

Primary endpoints

3-month all-cause mortality

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov