RecruitingPhase 3NCT05814432

Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS

Efficacy and Safety of High-dose Liposomal Amphotericin B (10 Mg/kg) for Disseminated Histoplasmosis in AIDS: a Randomized Phase III Trial (INDUCTION Trial)


Sponsor

Federal University of Health Science of Porto Alegre

Enrollment

279 participants

Start Date

Jan 16, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a high-dose regimen of liposomal amphotericin B (a powerful antifungal medication) is more effective at treating disseminated histoplasmosis — a serious fungal infection that has spread through the body — in people living with HIV/AIDS. **You may be eligible if...** - You are an adult living with HIV (regardless of whether you are on antiretroviral therapy) - You have been diagnosed with disseminated histoplasmosis, confirmed by microscopy, culture, tissue biopsy, or a urine antigen test - You are admitted to one of the participating hospitals **You may NOT be eligible if...** - You do not have confirmed histoplasmosis - You are not HIV-positive - You have a central nervous system infection from a different cause that cannot be distinguished from histoplasmosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSingle high dose of liposomal amphotericin B

Single high dose (10 mg/kg) of liposomal amphotericin B as induction therapy for disseminated histoplasmosis in AIDS

DRUGL-AmB standard dose

Standard treatment (3 mg/kg for two weeks) with liposomal amphotericin B as induction therapy for disseminated histoplasmosis in AIDS


Locations(5)

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

View Full Details on ClinicalTrials.gov

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NCT05814432


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