drugset / Trial / NCT07350174
Phase 2a Trial of Alpibectir Plus Ethionamide for Tuberculosis Meningitis
RandomizedParallel-groupOpen-labelTreatment
Summary
AlpE is a novel drug combination under development for the treatment of TB, with several positive attributes for TBM, including rapid bactericidal activity. The current trial aims to assess the plasma and CSF PK, as well as the safety and tolerability of alpibectir and three doses of Eto in patients with newly diagnosed TBM. Additionally, it is attended to investigate the effect of AlpE on the PK and efficacy of DTG during the first month of antiretroviral treatment (ART) for Human Immunodeficiency Virus (HIV)-positive patients.
Timeline
- Start
- 2026-03-30
- Primary completion
- 2028-03-30
- Completion
- 2028-10-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alpibectir | Unknown | 30 mg | — |
| Subject | Ethionamide | Small molecule | 375 mg | — |
| Subject | Ethionamide | Small molecule | 500 mg | — |
| Subject | Ethionamide | Small molecule | 625 mg | — |
| Comparator | Ethambutol | Small molecule | 20 mg/kg | — |
| Comparator | Isoniazid | Small molecule | 5 mg/kg | — |
| Comparator | Pyrazinamide | Small molecule | 30 mg/kg | — |
| Comparator | Rifampin | Small molecule | 10 mg/kg | — |