Efficacy and Safety of High-dose L-AmB for Disseminated Histoplasmosis in AIDS
Status:
Not yet recruiting
Trial end date:
2026-02-28
Target enrollment:
Participant gender:
Summary
Histoplasmosis is a systemic mycosis endemic in the Americas and Brazil. HIV-infected
patients are susceptible to disseminated histoplasmosis (HD), AIDS-defining illness. The
classic diagnosis requires a fungal culture that takes 4-6 weeks to grow. Brazilian patients
are diagnosed by culture or by histopathology and American patients have their diagnosis in
1-2 days, by Histoplasma antigen detection in urine. Amphotericin B treatment Liposomal
(L-AmB) is recommended by the American Society for Infectious Diseases and WHO, while the
Brazilian AIDS Program does not fund the use of L-AmB, delegating responsibility to the
states. As a result, patients with AIDS+HD do not have access to new diagnostic tests or
L-AmB, receiving late treatment with AmB-d, which results in increased mortality >45%. The
single high dose liposomal amphotericin B treatment study, aims to improve the availability
of access to medication, something that has already been demonstrated successfully by our
group in a phase II study. This proposal seeks to determine the efficacy and safety of two
L-AmB regimens as induction therapy for HD in AIDS patients: 10 mg/kg single dose versus 3
mg/kg for two weeks.
Phase:
Phase 3
Details
Lead Sponsor:
Federal University of Health Science of Porto Alegre