Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS
Recruiting · NCT05814432 · Interventional (participants receive a specific treatment) · Lead sponsor: Federal University of Health Science of Porto Alegre
View the official record on ClinicalTrials.gov →Interventions studied
L-AmB standard doseSingle high dose of liposomal amphotericin B
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
5 locations listed.
- Hospital de Doenças Tropicais - Goiânia, Goiás, Brazil
- Hospital Giselda Trigueiro - Natal, Rio Grande do Norte, Brazil
- Federal University of Health Sciences of Porto Alegre - Porto Alegre, Rio Grande do Sul, Brazil
- Hospital de Clinicas de Porto Alegre - Porto Alegre, Rio Grande do Sul, Brazil
- Hospital Geral de Roraima - Boa Vista, Roraima, Brazil