Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS
Efficacy and Safety of High-dose Liposomal Amphotericin B (10 Mg/kg) for Disseminated Histoplasmosis in AIDS: a Randomized Phase III Trial (INDUCTION Trial)
Federal University of Health Science of Porto Alegre
279 participants
Jan 16, 2025
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria5
- 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
- Patients with central nervous system (CNS) infection may be included if they have an alternative diagnosis suggestive of another CNS infection
- Patients using fluconazole for oroesophageal candidiasis may be included
Exclusion Criteria12
- Refusal to participate in the trial
- Previous diagnosis of histoplasmosis
- Pregnant or lactating women
- Patients with renal failure at any given time (serum creatinine \> 2x or upper limit of normality (KDIGO, 2012)
- 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 with suspected histoplasmosis involving the central nervous system (CNS), as this condition requires high doses of amphotericin B
- Patients with the prospect of death in the next 48 hours after selection
- Patients with a concomitant diagnosis of cryptococcus will be excluded, as will patients with leishmaniasis in treatment or in secondary prophylaxis with amphotericin
- Patients without the capacity to administer enteral medication-at the discretion of the principal investigator of each center-considering that these patients will not be able to use itraconazole orally or through a feeding tube
Interventions
Single high dose (10 mg/kg) of liposomal amphotericin B as induction therapy for disseminated histoplasmosis in AIDS
Standard treatment (3 mg/kg for two weeks) with liposomal amphotericin B as induction therapy for disseminated histoplasmosis in AIDS
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT05814432