Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
240 participants
INTERVENTIONAL
2026-02-15
2030-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BPaLMZ Regimen
bedaquiline, pretomanid, linezolid, moxifloxacin, and pyrazinamide (BPaLMZ)
BPaLMZ Regimen
bedaquiline, pretomanid, linezolid, moxifloxacin, and pyrazinamide
Standard of Care Regimen
rifampicin, isoniazid, pyrazinamide, ethambutol (RHZE) therapy
No interventions assigned to this group
Interventions
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BPaLMZ Regimen
bedaquiline, pretomanid, linezolid, moxifloxacin, and pyrazinamide
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years
* Provision of Informed Consent by participant or surrogate
* Living with HIV
* Weight \> 35kg, estimate or measured
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Infectious Diseases Institute
UNKNOWN
University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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David Boulware, MD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Infectious Diseases Institute
Kampala, , Uganda
Countries
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Central Contacts
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Facility Contacts
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David Boulware, MD
Role: primary
David Meya, MBChB, MMed, PhD
Role: primary
Other Identifiers
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STUDY00024610
Identifier Type: -
Identifier Source: org_study_id