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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal University of Health Science of Porto Alegre
• Treatments: Amphotericin B; Liposomal amphotericin B

Criteria

Inclusion Criteria:

• Adult patients admitted to the centers that will be part of the study.

• Infected by HIV in AIDS and diagnosed with DH, through:

(i) positive Histoplasma antigen in the urine (monoclonal antibody test IMMY® Clarus); (ii) confirmation by classical mycological methods; or (iii) positive qualitative in-house Histoplasma polymerase chain reaction (PCR) test (according to the availability of the centers).

• Patients regardless of the use of antiretroviral therapy (ART).

Exclusion Criteria:

• Patients with a previous diagnosis of histoplasmosis.

• Pregnant or lactating women.

• Patients with renal impairment (serum creatinine and BUN >1.5x the upper limit of normal) and patients with a previous severe reaction to a polyene antifungal.