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

Prior treatment

• Previous diagnosis of histoplasmosis
• Previous severe reaction to a polyene antifungal
• 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

Other illness

• Patients with suspected histoplasmosis involving the central nervous system (CNS), as this condition requires high doses of amphotericin B

Lab values

• Patients with renal failure at any given time (serum creatinine \> 2x or upper limit of normality (KDIGO, 2012)

Other

• Refusal to participate in the trial
• Pregnant or lactating women
• 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 the prospect of death in the next 48 hours after selection

• 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