The purpose of this study is to examine the antifungal activity of recombinant interferon-gamma 1b (rIFN-gamma 1b) given with standard antifungal therapy.
Patients are randomized into 1 of 3 parallel groups for a 3-arm, 2-stage, double-blind and dose-ranging study for 14 weeks. In Stage 1, patients are hospitalized for 14 days of acute therapy. Patients receive rIFN-gamma 1b or placebo sc 3 times per week, intravenous (IV) AMB daily, and with or without oral 5-FC every 6 hours. Patients who have the ability to take oral medications, who do not have any significant clinical deterioration during the previous 14 days, and who meet the eligibility criteria can progress to Stage 2. In Stage 2 patients receive 84 days of consolidation therapy (56 days with study drug and 28 days of follow-up). On an outpatient basis, patients receive either placebo or 1 of 2 doses of rIFN-gamma 1b sc 3 times per week, and oral fluconazole daily or oral itraconazole 2 times a day.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Univ of Alabama at Birmingham
Birmingham, Alabama, United States
Washington Univ
St Louis, Missouri, United States
UMDNJ - New Jersey Med School / Cooper Hosp
Camden, New Jersey, United States
Univ of Med & Dentistry of New Jersey
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Newark, New Jersey, United States
Houston Veterans Administration Med Ctr
Houston, Texas, United States
Univ of Texas / Med School at Houston
Houston, Texas, United States
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, United States
Hosp Nacional dos de Mayo
Lima, Peru
Instituto de Medicina Tropical
Lima, Peru