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

Phase 2

Completed

• Conditions: Meningitis, Cryptococcal; HIV Infections

• Registration Number: NCT00012467
• Lead Sponsor: InterMune

Brief 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.

Study Timeline

• Study Start: 2000-01
• Study First Submitted: 2001-03-09
• Study Completion: 2001-07
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-29
• Last Update Posted: 2009-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (9)

Houston Veterans Administration Med Ctr; 🇺🇸 Houston, Texas, United States

Univ of Texas / Med School at Houston; 🇺🇸 Houston, Texas, United States

Instituto de Medicina Tropical; 🇵🇪 Lima, Peru

Hosp Nacional dos de Mayo; 🇵🇪 Lima, Peru

UMDNJ - New Jersey Med School / Cooper Hosp; 🇺🇸 Camden, New Jersey, United States

Univ of Med & Dentistry of New Jersey; 🇺🇸 Newark, New Jersey, United States

Washington Univ; 🇺🇸 St Louis, Missouri, United States

Audie L Murphy Veterans Administration Hosp; 🇺🇸 San Antonio, Texas, United States

Univ of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States