Phase 2 Trial Comparing BPaLMZ Combination Therapy to Standard Treatment for Tuberculous Meningitis in Adults with HIV

What this Trial Is About

Researchers are evaluating a new combination drug therapy called BPaLMZ for treating tuberculous meningitis in adults living with HIV. This Phase 2 study compares participants receiving BPaLMZ to those receiving the standard care regimen of rifampicin, isoniazid, pyrazinamide, and ethambutol RHZE. The study aims to assess treatment outcomes including survival and functional status over 24 weeks. Participants are randomly assigned to receive either the BPaLMZ regimen, which includes bedaquiline, pretomanid, linezolid, moxifloxacin, and pyrazinamide, or the standard care regimen with rifampicin, isoniazid, pyrazinamide, and ethambutol. The study follows a parallel design without masking. Both treatment groups are monitored closely for up to 28 weeks to assess safety and efficacy markers. During the study, participants undergo evaluations of survival time, functional status, serious adverse events, clinical adverse events, laboratory abnormalities, neuropathy, and drug-induced liver injury. Researchers also measure inflammatory markers in cerebrospinal fluid and blood, neurocognitive performance, mental status changes, and corticosteroid use. Follow-up assessments occur at various time points up to 28 weeks, with a primary focus on outcomes at 24 weeks, providing comprehensive monitoring throughout the study period.

B-PaLMZ for TB Meningitis