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

Recruiting Phase 3 Interventional Study
Disseminated Histoplasma Capsulatum Infection AIDS and Infections Immunosuppression Fungal Infection
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
279 (estimated)
Sponsor
Federal University of Health Science of Porto Alegre · Other
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About This Trial

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).

Trial Locations
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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…
Contacts

Alessandro C Pasqualotto, MD PhD

+5551999951614

acpasqualotto@hotmail.com

CONTACT

Diego R Falci, MD PhD

+5551997507835

diego.falci@gmail.com

CONTACT