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).
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
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)
Federal University of Health Science of Porto Alegre
Lead sponsor
Gilead Sciences
Collaborator
Financiadora de Estudos e Projetos
Collaborator
Sociedade Gaucha de Infectologia
Collaborator
Immuno-mycologics, Inc. (IMMY)
Collaborator