NCT00012467

Safety and Antifungal Activity of Recombinant Interferon-Gamma 1b (rIFN-Gamma 1b) Given With Standard Therapy in Patients With Cryptococcal Meningitis

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Phase II Study of the Safety and Antifungal Activity of Subcutaneous Recombinant Interferon-Gamma 1b (rIFN-Gamma 1b) in Conjunction With Standard Therapy in Patients With Acute Cryptococcal Meningitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: InterMune · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the antifungal activity of recombinant interferon-gamma 1b (rIFN-gamma 1b) given with standard antifungal therapy.

Detailed description

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.

Conditions

• Meningitis, Cryptococcal
• HIV Infections

Interventions

Type	Name	Description
DRUG	Itraconazole
DRUG	Flucytosine
DRUG	Fluconazole
DRUG	Amphotericin B
DRUG	Interferon gamma-1b

Timeline

• Start date: 2000-01-01
• Completion: 2001-07-01
• First posted: 2001-08-31
• Last updated: 2009-06-03

Locations

9 sites across 2 countries: United States, Peru