Endemic Mycoses Treatment With SUBA-itraconazole vs Itraconazole
Status:
Active, not recruiting
Trial end date:
2021-10-31
Target enrollment:
Participant gender:
Summary
This is a prospective, multi-center, randomized, open-label parallel arm study involving
patients with proven or probable invasive endemic fungal infection to ascertain the
pharmacokinetics, safety, efficacy, tolerability and health economics of oral
SUBA-itraconazole compared to conventional itraconazole. Patients will receive randomized
open-label study drug (SUBA-itraconazole or conventional itraconazole) over a 42 day period
and then continue therapy until Day 180. Patients will be stratified based on clinically
reported infection with the human immunodeficiency virus (HIV).
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
University of Alabama at Birmingham
Collaborators:
University of California, Davis Washington University School of Medicine