A Phase 2 interventional study of BPaLMZ Regimen in Tuberculous Meningitis, HIV and Meningitis, sponsored by David Boulware. Recruiting at 2 sites in Uganda. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by David Boulware · Phase 2, Interventional, and Treatment
This two-stage study will compare consented research participants with tuberculous meningitis receiving experimental Bedaquiline (B), Pretomanid (Pa), Linezolid (L); Moxifloxacin (M), Pyrazinamide (Z) known as (BPaLMZ) to controls receiving SOC of rifampicin (R), isoniazid (H), pyrazinamide (Z), and ethambutol (E), known as RHZE. The experimental regimen is known as 1BPaLMZ/5PaM.
1BPaLMZ/5PaM regimen for TB meningitis
31 studies on the registry are indexed under Tuberculosis, Meningeal; 9 are open to participants now.
This study's planned enrollment of 312 is above the median of 125 across 24 interventional studies indexed under Tuberculosis, Meningeal.
Browse Tuberculosis, Meningeal studies →David Boulware is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
bedaquiline, pretomanid, linezolid, moxifloxacin, and pyrazinamide (BPaLMZ)
Drug: BPaLMZ Regimen
rifampicin, isoniazid, pyrazinamide, ethambutol (RHZE) therapy
bedaquiline, pretomanid, linezolid, moxifloxacin, and pyrazinamide
24-week Survival
Survival Time
Time frame: 24 Weeks
Hierarchical composite endpoint (survival time + functional status)
Hierarchical composite endpoint of survival time and Rankin score (0-5 scale) assessed by Win Ratio
Time frame: 24 Weeks
Serious adverse events (SAE)
Incidience of Serious adverse events
Time frame: 28 weeks
Clinical Adverse Events
Clinical Adverse Events, by grade (1-5) associated with TB drug discontinuation, dose reduction, or interruption \>=3 days
Time frame: 28 weeks
Laboratory abnormalities
Number of participants with grade 3 or 4 abnormal laboratory values, by the Division of AIDS toxicity grading scale
Time frame: 28 weeks
Neuropathy
Incidence of Neuropathy
Time frame: 28 weeks
Drug induced liver injury
Drug induced liver injury with Grade \>=3 with serum alanine aminotransferase (ALT) \>5x upper limit or normal or total bilirubin \>2.5x upper limit of normal)
Time frame: 28 weeks
Change in CSF inflammatory markers
Change in CSF leukocytes from baseline to day 7 and 14 visits.
Time frame: 14 days
Modified Rankin Scale
Modified Rankin Score as an ordinal score (0-6 scale) of: 0 Alive: no residual symptoms or disability. 1. No significant disability: symptoms are present but do not prevent carrying out all usual duties and activities; able to carry out all pre-TBM activities. 2. Slight disability: unable to carry out all pre-TBM activities but able to look after self without daily help. 3. Moderate disability: requires some assistance with tasks but able to walk without assistance. 4. Moderately severe disability: unable attend to bodily functions or walk without assistance. 5. Severe disabilities: bedridden, incontinent, requires continuous care and attention. 6. Dead
Time frame: 24 weeks
Change in blood inflammatory markers
Change in white blood cell count from baseline to day 7 visit
Time frame: 7 days
Quantitative neurocognitive performance Z-score
Quantitative neurocognitive performance Z-score scaled to Ugandan population adult norms where population average = 0. Performance is Z-scored such that performance that is one standard deviation better than average is +1 and one standard deviation worse is -1.
Time frame: 24 weeks
Change in PCR cycle threshold (Ct) value in CSF
Change in PCR cycle threshold (Ct) value in CSF from baseline to Day 7 and 14 visits.
Time frame: 14 days
Altered Mental Status over time
Number of days with Glasgow Coma Scale score = 15 within the first 10 days
Time frame: 10 days
Additional corticosteroids use
Additional corticosteroids use in TBM survivors (beyond initial use)
Time frame: 24 weeks
Change in CSF glcuose
Change in CSF glucose from baseline to day 7 to day 14
Time frame: 14 days
Change in serum C-reactive protein
Change in serum C-reactive protein (CRP) from baseline to day 7
Time frame: 7 days
Plan to share: Yes — deidentified dataset
Supporting information: Study protocol
Time frame: At time of publication, as per ICJME
Access criteria: public access
Data sharing details ↗ · dataverse.harvard.edu
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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David Boulware