PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY ON SAFETY AND EFFECTIVENESS OF THE GAMMA-1B SUBCUTANEOUS INTERPHERE (IFN-Y 1B) IN COMBINATION WITH STANDARD ANTIFUNGAL THERAPY FOR THE TREATMENT OF ACUTE CRYTOCOCCAL MENINGITIS IN PATIENTS WITH ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS).
- Conditions
- B20-B20 Human immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseasesHuman immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases
- Registration Number
- PER-022-03
- Lead Sponsor
- INTERMUNE PHARMACEUTICALS, INC.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
The present is a Phase III study. Multicenter, multinational, randomized, double-blind, placebo-controlled subcutaneous treatment with IFN-y 1b, administered three times a week for 10 weeks, in patients with AIDS with acute cryptococcal meningitis. Patients will be treated concomitantly with amphotericin B with or without 5-flucylosin. during the first 14 days, followed by fluconazole for the remainder of the 10-week active treatment period, and the 12-week follow-up period.
Coma.
Kamofsky scale <30.
Life expectancy <2 weeks.
Pre-treatment for this event with more than 3 mg / kg (or more than three daily doses> 1.0 mg / kg / d) of amphotericin B deoxycholate, or more than 18 mg / kg (or more than three daily doses> 4-6 mg / kg / d) of a lipid-based amphotericin formulation, or more than 1200 mg (or more than three daily doses> 400 mg / d of fluconazole or ltraconazole.
Start of treatment for this event more than 72 hours before the start of the study medication.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:CSF culture<br>Measure:Efficacy of IFN-y Ib to achieve a conversion of CSF culture to negative and neurological stability or improvement at 2 weeks, in patients with AIDS with acute cryptococcal meningitis.<br>Timepoints:2 weeks<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:CSF culture<br>Measure:Effect of therapy with IFN-y 1b, in conjunction with concomitant standard antifungal therapy, in CSF culture conversion rate to negative at 2 weeks.<br>Timepoints:2 weeks<br>