Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS (NCT05814432) | Clinical Trial Compass
RecruitingPhase 3
Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS
Brazil279 participantsStarted 2025-01-16
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 criteria:
* 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 sec…
What they're measuring
1
Overall survival rate
Timeframe: 14 days
Trial details
NCT IDNCT05814432
SponsorFederal University of Health Science of Porto Alegre