BPaLMZ for TB Meningitis: a two-stage trial comparing an experimental regimen to standard therapy
Official title: A PHASE 2 NOVEL ANTIMICROBIAL COMBINATION THERAPY TO TREAT TUBERCULOUS MENINGITIS
Run by University of Minnesota · NCT07227779 · Data updated 2026-11-12
This phase 2 trial tests whether the BPaLMZ combination can be better than standard TB meningitis treatment in adults living with HIV who have TB meningitis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 312 (estimated) |
| Sponsor | University of Minnesota Academic / other |
| Locations | 2 sites (Kampala and 1 other locations) |
| Status | Recruiting |
| Started | July 28, 2026 |
| Main results expected | March 31, 2028 |
| Study ends | September 30, 2030 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT07227779 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with definite or probable TB meningitis who are living with HIV and able to consent, weighing more than 35 kg.
✕Probably not a fit
Patients with rifampicin-resistant TB, significant liver or kidney dysfunction, certain cardiac risks, or other exclusion criteria may not benefit from the experimental regimen.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a two-stage, interventional phase 2 trial in adults with tuberculous meningitis and HIV. It compares an experimental regimen (BPaLMZ) to the standard RHZE therapy, with a specific 1BPaLMZ/5PaM scheme described. Participants are consented adults with definite or probable TB meningitis, and outcomes will inform safety and potential efficacy signals. The study is conducted with international collaboration across Uganda and the UK, led by Dr. David Boulware and partners including Infectious Diseases Institute and University of Minnesota. Enrollment will proceed at multiple sites in Uganda, with careful screening to exclude significant organ dysfunction, cardiac risk, and contraindications to study drugs.
Why it matters
Potential benefit: If successful, patients with TB meningitis and HIV could have improved treatment options and outcomes compared with standard therapy.
How similar studies have gone: Previous studies in TB meningitis have explored intensified drug regimens, but this specific BPaLMZ approach is a targeted, newer combination under phase 2 investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Infectious Diseases Institute
Kampala, Uganda Recruiting -
Mbarara University of Science and Technology
Mbarara, Uganda Recruiting
Study contacts
- Principal investigator: David Boulware, MD — University of Minnesota
- Study coordinator: David Boulware, MD
- Email: coat.trial@gmail.com
- Phone: 612-624-9996
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.