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

Launched by FEDERAL UNIVERSITY OF HEALTH SCIENCE OF PORTO ALEGRE · Apr 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with disseminated histoplasmosis, a serious fungal infection that can affect people with AIDS. The researchers want to see if a single high dose of a medication called liposomal amphotericin B (10 mg/kg) is more effective and safe compared to the standard treatment, which involves a lower dose (3 mg/kg) given over two weeks. The trial is currently recruiting adult patients who are hospitalized and have been diagnosed with this infection, regardless of their HIV treatment status.

To participate, patients must be adults with a confirmed diagnosis of disseminated histoplasmosis. However, there are some criteria that would exclude individuals from participating, such as having a previous diagnosis of histoplasmosis, being pregnant or breastfeeding, or having certain severe health conditions like kidney failure. If eligible, participants can expect to receive the high-dose medication and will be monitored for safety and effectiveness during the study. This trial is important as it may lead to better treatment options for people suffering from this serious infection.

Gender

ALL

Eligibility criteria

• 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 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