Not Yet RecruitingPhase 2

Phase 2a Trial of Alpibectir Plus Ethionamide for Tuberculosis Meningitis

64 participantsStarted 2026-03-30

Plain-language 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.

Who can participate

Age range15 Years – 64 Years

SexALL

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Inclusion criteria

✓. Age ≥ 15 years and \< 65 years
✓. Diagnosis of TBM defined as "definite" or "probable", using criteria proposed by the Tuberculosis Meningitis International Research Consortium.
✓. Informed consent signed by the patient. For patients with Glasgow Coma Scale (GCS) \< 15, the consent of a next of kin/relative will be required, in accordance with applicable local laws and regulations. Deferred consent will be obtained from the participant when their level of consciousness improves, and they have capacity to provide consent. For adolescents below the age of civil majority (as defined in each country), the consent of at least one parent or legal guardian and the assent of the adolescent will be required.

Exclusion criteria

✕. 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.
✕. Renal failure (eGFR \< 30 mL/min, calculated by CKD-EPI formula).
✕. Alanine aminotransferase (ALT) \> 5 times the Upper Limit of Normal.
✕. Clinical evidence of liver failure or decompensated cirrhosis.
✕. For women of childbearing potential, one or more of the following:

What they're measuring

To describe the pharmacokinetics (PK) of AlpE in plasma and cerebrospinal fluid (CSF) in patients with newly diagnosed Tuberculosis Meningitis (TBM)

Timeframe: 15 days

Trial details

NCT IDNCT07350174

SponsorBioVersys AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-03-30

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