Phase 2
N=118
Randomized Trial of Liposomal Amphotericin B for Histoplasmosis in AIDS Patients
Histoplasmosis · AIDS
Bottom Line
View on ClinicalTrials.gov: NCT04059770 ↗Enrolled (actual)
118
Serious AEs
9.7%
Results posted
Mar 2025
Primary outcome: Primary: Clinical Response — 32; 25; 28 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- single dose of L-AmB (Drug); 2 doses of L-AmB (Drug); 2 weeks of L-AmB (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alessandro Pasqualotto
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response |
32; 25; 28 | — |
| SECONDARY Overall Mortality |
4; 8; 3 | — |
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 of choice for AIDS-associated histoplasmosis.However, many patients in Latin America are still treated with high doses of deoxycholate amphotericin B (d-AmB) for long periods. These regimens are associated with toxicity and thus reduced efficacy. Therefore, a better treatment strategy is necessary to improve the activity of this amphotericin B treatment. Treatment with a high dose of L-AmB for short periods (rather than standard doses for longer periods) is a promising approach considering that the antifungal effect of amphotericin B depends on peak concentrations. This randomized open-label Phase II study aims to determinate and to compare the activity and safety of three L-AmB regimens, as induction therapy for DH in AIDS patients.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04059770). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.