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

Recruiting now · Phase 3

Conditions studied: Disseminated Histoplasma Capsulatum Infection, AIDS and Infections, Immunosuppression, Fungal Infection

In brief

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).

Key facts

Study ID

NCT05814432

Run by

Federal University of Health Science of Porto Alegre

People needed

279

Starts

2025-01-16

Expected to finish

2032-07-01

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)
• Previous severe reaction to a polyene antifungal
• 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 suspected histoplasmosis involving the central nervous system (CNS), as this condition requires high doses of amphotericin B
• Patients with the prospect of death in the next 48 hours after selection
• 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

Where it is running

• Hospital de Doenças Tropicais — Goiânia, Goiás, Brazil (enrolling)
• Hospital Giselda Trigueiro — Natal, Rio Grande do Norte, Brazil (enrolling)
• Federal University of Health Sciences of Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
• Hospital de Clinicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
• Hospital Geral de Roraima — Boa Vista, Roraima, Brazil (enrolling)

Full record on ClinicalTrials.gov

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