Efficacy and Safety of High-dose Liposomal Amphotericin B (10 mg/kg) for Disseminated Histoplasmosis in AIDS: a Randomized Phase III Trial (INDUCTION Trial)

67938323.0.1001.5345

Phase III trial evaluating the safety and efficacy of a single high dose (10 mg/kg) of liposomal amphotericin B for disseminated histoplasmosis in AIDS patients, in comparison to standard therapy (3 mg/kg of liposomal amphotericin B for two weeks) (INDUCTION trial).

2024-03-01

2025-05-28

2026-05-28

Not yet recruiting

Early phase I

254

Inclusion Criteria: * Adult patients admitted to the centers that will be part of the study * Infected by the HIV, regardless of the use of antiretroviral therapy * Patients diagnosed with disseminated histoplasmosis, confirmed by classical mycological methods (microscopy, culture or histopathology) or urinary Histoplasma antigen detection * Presence of fever in addition to one of the following: weight loss (\>10% of usual body weight), diarrhea, miliary pattern on thorax imaging, pancytopenia, lymphadenopathy, splenomegaly, or hepatomegaly Exclusion criteria: * Refusal to participate in the trial * Previous diagnosis of histoplasmosis * Pregnant or lactating women * Renal impairment (serum creatinine or urea \>1.5x the upper limit of normal) * Previous severe reaction to a polyene antifungal * Receipt of more than one dose of a polyene antifungal in the last 48 h * Suspected histoplasmosis involving the central nervous system * Patients who, in the judgment of the attending physician, have the prospect of death within the next 48 hours after selection, will also be excluded. * Patients diagnosed with tuberculosis (molecularly or microbiologically) at baseline will be excluded, as rifampicin prohibitively interacts with itraconazole; in addition, patients receiving drugs that cause significant drug interaction (relative or absolute) with Itraconazole, will be excluded.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 254, 'type': 'ESTIMATED'}}

2024-02-22