Actively Recruiting
Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS
Led by Federal University of Health Science of Porto Alegre · Updated on 2025-02-04
279
Participants Needed
5
Research Sites
97 weeks
Total Duration
On this page
Sponsors
F
Federal University of Health Science of Porto Alegre
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
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).
CONDITIONS
Official Title
Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients admitted to the participating centers
- Diagnosed with HIV infection, regardless of antiretroviral therapy use
- Confirmed disseminated histoplasmosis by microscopy, culture, histopathology, or urinary Histoplasma antigen
- Patients with central nervous system infection may be included if an alternative diagnosis suggests another CNS infection
- Patients using fluconazole for oroesophageal candidiasis may be included
You will not qualify if you...
- Refusal to participate in the trial
- Previous diagnosis of histoplasmosis
- Pregnant or lactating women
- Renal failure at any time (serum creatinine > 2x upper limit of normal)
- Previous severe reaction to a polyene antifungal
- Received more than one dose of a polyene antifungal in the last 48 hours
- Suspected central nervous system involvement of histoplasmosis
- Prospect of death within 48 hours after selection
- Concomitant diagnosis of cryptococcus or leishmaniasis under treatment or prophylaxis with amphotericin
- Inability to take oral medication as judged by the principal investigator
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Hospital de Doenças Tropicais
Goiânia, Goiás, Brazil
Actively Recruiting
2
Hospital Giselda Trigueiro
Natal, Rio Grande do Norte, Brazil
Actively Recruiting
3
Federal University of Health Sciences of Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
Actively Recruiting
4
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Actively Recruiting
5
Hospital Geral de Roraima
Boa Vista, Roraima, Brazil
Actively Recruiting
Research Team
A
Alessandro C Pasqualotto, MD PhD
CONTACT
D
Diego R Falci, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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