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New hope for brain infection: experimental combo tackles tuberculous meningitis

NCT ID NCT07227779

Disease control Sponsor: David Boulware Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 8 times

Summary

This study tests a new combination of medicines (BPaLMZ) against the standard treatment for tuberculous meningitis, a serious brain infection. About 240 adults, including those living with HIV, will take part. The goal is to see if the new combo helps more people survive and recover better brain function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 312 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * First Episode definite or probable TBM with physician intent to treat * Age ≥18 years * Provision of Informed Consent by participant or surrogate * Living with HIV * Weight \> 35kg, estimate or measured Exclusion Criteria: * Additional active and confirmed CNS infection * Known rifampicin-resistant TB * Allergy or contraindication to a study medicine * More than 5 doses of any TB therapy received within the previous 14 days * Presence of jaundice, known liver cirrhosis, elevated ALT or AST \>3x ULN, or total bilirubin \>2x ULN * Estimated Glomerular Filtration Rate \<30 ml/min/1.73m2 * Significant cardiac comorbidity, heart failure, arrhythmia, or QTc \>450 ms * Pregnancy or Breastfeeding * Cryptococcal antigen positivity in blood * Condition which makes participation not in the participant's best interest

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Conditions

The condition(s) this trial relates to.

HIV infectious disease latent tuberculosis infection meningeal tuberculosis meningitis tuberculosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV Meningitis TB - tuberculosis Tuberculous meningitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Infectious Diseases Institute

    RECRUITING

    Kampala, Uganda

  • Mbarara University of Science and Technology

    RECRUITING

    Mbarara, Uganda

More trials for these conditions

Other studies related to the condition(s) this trial covers.