Phase 2a Trial of Alpibectir Plus Ethionamide for Tuberculosis Meningitis
ConditionTuberculosis Meningitis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age15-64
SponsorBioVersys AG
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 15 years and < 65 years
Diagnosis of TBM defined as "definite" or "probable", using criteria proposed by the Tuberculosis Meningitis International Research Consortium.
Definite TBM is defined by at least one of the following criteria: acid-fast bacilli (AFB) seen in CSF microscopy, positive CSF M. tuberculosis culture, or positive CSF M. tuberculosis commercial nucleic acid amplification test in the setting of symptoms suggestive of meningitis.
Probable TBM is defined using a modified Marais score* Probable TBM: total score* ≥ 12 when neuroimaging is available, or ≥ 10 when neuroimaging is not available. At least 2 points should come from CSF or 2 points from cerebral imaging criteria.
Disqualifiers
Having received >14 days of HRZE TB treatment.
In people with HIV infection: use of antiretroviral treatment (ART) other than efavirenz- or dolutegravir-based.
Glasgow Coma Scale < 10.
Body weight measured or estimated: < 40 kg or > 90 kg or BMI > 40 kg/m2.
Trial design
Treatments tested in this trial
- HRZE
- HRZE plus Alpe375
- HRZE plus AlpE500
- HRZE plus AlpE625
Treatment groups
64 Participants
are divided into 4 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov