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Clinical Trial 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).


Clinical Trial Description

Histoplasmosis is a serious endemic mycosis that may disseminate in immunocompromised patients. The disease in endemic in the American continent, particularly Brazil. Patients with advanced HIV infection are susceptible to disseminated histoplasmosis, an AIDS-defining illness. According to international guidelines, induction therapy for disseminated histoplasmosis involves the use of liposomal amphotericin B for two weeks, but access to this medication is limited in several regions of the globe. A phase II trial showed promising results with the use of a single high dose of liposomal amphotericin B in this context. Here we propose a phase III study aimed to evaluate safety and efficacy of induction therapy with liposomal amphotericin B for disseminated histoplasmosis in AIDS, comparing 10 mg/kg (interventional arm) versus 3 mg/kg for two weeks (standard therapy). Induction therapy will be followed by oral itraconazole for one year for all patients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05814432
Study type Interventional
Source Federal University of Health Science of Porto Alegre
Contact Alessandro C Pasqualotto, MD PhD
Phone +5551999951614
Email acpasqualotto@hotmail.com
Status Not yet recruiting
Phase Phase 3
Start date March 1, 2024
Completion date May 28, 2026

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