Phase I EnACT Trial of the Safety and Tolerability of a Novel Oral Formulation of Amphotericin B
Caleb P Skipper, Mucunguzi Atukunda, Anna Stadelman, Nicole Engen, Ananta Bangdiwala, Katherine Huppler Hullsiek, Mahsa Abassi, Joshua Rhein, Melanie R. Nicol, Eva Laker, Darlisha A Williams, Raphael J. Mannino, Theresa Matkovits, David B. Meya, David R. Boulware
Abstract
Amphotericin B deoxycholate (AMB) has substantial toxicities. A novel encochleated amphotericin B deoxycholate (cAMB) formulation has oral bioavailability, efficacy in an animal model, and minimal toxicity due to targeted drug delivery into macrophages, where intracellular fungi reside. We conducted a phase I, ascending-dose trial of cAMB administered at 1.0 g, 1.5 g, or 2.0 g per day in 4 to 6 divided doses among HIV-positive survivors of cryptococcosis ( n = 9 per cohort).
Topics & Concepts
TolerabilityAmphotericin BAmphotericin B deoxycholateBioavailabilityPharmacokineticsPharmacologyMedicineToxicityDrugAdverse effectInternal medicineAntifungalDermatologyCaspofunginAntifungal resistance and susceptibilityFungal Infections and StudiesInfectious Diseases and Mycology