NCT05814432 Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS
| NCT ID | NCT05814432 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Federal University of Health Science of Porto Alegre |
| Condition | Disseminated Histoplasma Capsulatum Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 279 participants |
| Start Date | 2025-01-16 |
| Primary Completion | 2026-08-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 279 participants in total. It began in 2025-01-16 with a primary completion date of 2026-08-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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
Contact & Investigator
Daiane F Dalla Lana, PhD
STUDY CHAIR
Federal University of Health Science of Porto Alegre
Frequently Asked Questions
Who can join the NCT05814432 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Disseminated Histoplasma Capsulatum Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05814432 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 279 participants.
Is NCT05814432 currently recruiting?
Yes, NCT05814432 is actively recruiting participants. Contact the research team at acpasqualotto@hotmail.com for enrollment information.
Where is the NCT05814432 trial being conducted?
This trial is being conducted at Goiânia, Brazil, Natal, Brazil, Porto Alegre, Brazil, Porto Alegre, Brazil and 1 additional location.
Who is sponsoring the NCT05814432 clinical trial?
NCT05814432 is sponsored by Federal University of Health Science of Porto Alegre. The principal investigator is Daiane F Dalla Lana, PhD at Federal University of Health Science of Porto Alegre. The trial plans to enroll 279 participants.