Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS
Key facts
- Where
- Boa Vista, Goiânia, Natal, and Porto Alegre, BrazilSee the 5 sites
- Phase
- Phase 3
Where in Brazil
- Hospital Geral de RoraimaBoa Vista, BrazilTaking people
- Hospital de Doenças TropicaisGoiânia, BrazilTaking people
- Hospital Giselda TrigueiroNatal, BrazilTaking people
- Federal University of Health Sciences of Porto AlegrePorto Alegre, BrazilTaking people
- Hospital de Clinicas de Porto AlegrePorto Alegre, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Federal University of Health Science of Porto Alegre
- Trial code
- NCT05814432
- Record updated
- 27 July 2026
- Original description
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).Read full original descriptionShow less
Efficacy and Safety of High-dose Liposomal Amphotericin B (10 mg/kg) for Disseminated Histoplasmosis in AIDS: a Randomized Phase III Trial (INDUCTION Trial)
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).
Inclusion: 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.
Exclusion: Previous diagnosis of histoplasmosis; Previous severe reaction to a polyene antifungal; 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; Patients with suspected histoplasmosis involving the central nervous system (CNS), as this condition requires high doses of amphotericin B; Patients with renal failure at any given time (serum creatinine \> 2x or upper limit of normality (KDIGO, 2012); Refusal to participate in the trial; Pregnant or lactating women; 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 the prospect of death in the next 48 hours after selection.