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).
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, and tolerability of oral SUBA-itraconazole or itraconazole. Patients will receive randomized open-label study drug (either SUBA- itraconazole 130 mg twice daily or itraconazole 200 mg twice daily) over a 42-day period and then continue on their assigned open-label therapy until day 180. The study sample size will be 80 evaluable patients - target enrollment (three arms: approximately 40 histoplasmosis, 20 coccidioidomycosis, 20 other endemic fungal infections).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
88
SUBA itraconazole study drug will consist of two 65 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 65mg capsules will be taken twice daily with food.
Conventional itraconazole comparator drug will consist of two 100 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 100 mg capsules will be taken twice daily with food.
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Arizona
Tucson, Arizona, United States
University of California at Davis
Sacramento, California, United States
Comparison of Plasma Itraconazole Levels and Hydroxyitraconazole Levels at Day 14
Percentage of participants to achieve therapeutic itraconazole and hydroxyitraconazole levels by evaluating Inter-patient variability as calculated by co-efficient of variation on plasma specimens collected on Day 14
Time frame: Day 14
Frequency of Treatment Related Adverse Events Days 1-42
Comparison of the number of treatment related adverse events in each arm occurring Days 1-42.
Time frame: Day 42
Comparison of Plasma Itraconazole Levels and Hydroxyitraconazole Levels at Day 42
Percentage of patients with therapeutic itraconazole and hydroxyitraconazole levels as measured in plasma trough levels Day 42
Time frame: Day 42
Resolution of Signs and Symptoms of Invasive Fungal Infection on Day 42
We will measure specific signs and symptoms related to endemic fungal infection, comparing baseline findings to Day 42 findings using physical examination and patient history.
Time frame: Day 42
The Number of Days of Hospitalization at Day 180
The number of days of Hospitalization occurring between Day 1-180
Time frame: Day 180
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Rush University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Metro Infectious Disease Associates
Overland Park, Kansas, United States
University of Michigan
Ann Arbor, Michigan, United States
Unniversity of Minnesota
Minneapolis, Minnesota, United States
Washington University in St. Louis
St Louis, Missouri, United States
Duke University Medical Center
Durham, North Carolina, United States
...and 2 more locations