Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS

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).

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 * 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 criteria: * 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