Status:
COMPLETED
Randomized Trial of Liposomal Amphotericin B for Histoplasmosis in AIDS Patients
Lead Sponsor:
Alessandro Pasqualotto
Collaborating Sponsors:
Hospital de Clinicas de Porto Alegre
Hospital Nossa Senhora da Conceicao
Conditions:
Histoplasmosis
AIDS
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Disseminated histoplasmosis (DH) is one of the major AIDS-defining infections responsible for high mortality rates in HIV-infected patients. Liposomal amphotericin B (L-AmB) is considered the therapy ...
Detailed Description
This is a prospective randomized non-comparative multicenter open label trial of induction therapy with LAmB for DH in AIDS patients, followed by oral therapy with itraconazole. The sample size plann...
Eligibility Criteria
Inclusion
- Adult (\> 18 years) HIV-infected hospitalized patients diagnosed with HD by the means of (i) urine Histoplasma positive antigen (IMMY® monoclonal antibody test); (ii) confirmation by classical mycological methods (microscopy, culture or histopathology); or (iii) Histoplasma positive qualitative polymerase chain reaction (PCR) in bronchoalveolar lavage samples, bone marrow aspirates or tissue samples.
- Patients will be included despite of the use of antiretroviral therapy (ART).
- Understanding and signed the Informed Consent Form.
Exclusion
- Patients with previous diagnosis of histoplasmosis.
- Pregnant or lactating women.
- Patients with renal insufficiency (serum creatinine and urea \> 1.5x the upper limit of normal).
- Abnormal aminotransferases (up to \> 3x the upper limit of normal) and patients with a severe prior reaction to polyene antifungal.
- Patients who have received more than one dose of a polyene antifungal in the last 48 hours.
- Patients who refuse to participate in the study.
- Patients diagnosed with histoplasmosis that affect the central nervous system.
- Patients who, at the trial of the attending physician, are expected to die within 48 hours.
- Patients diagnosed with tuberculosis.
- Patients with any disease or condition that, in the opinion of the investigator, may interfere with the assessments or participation in the study.
- Patients receiving drugs that cause significant (relative or absolute) drug interaction with Itraconazole.
Key Trial Info
Start Date :
February 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2022
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT04059770
Start Date
February 14 2020
End Date
March 30 2022
Last Update
March 14 2025
Active Locations (1)
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1
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090