None listed
Conditions
Interventions
Treatment is administered with INF-y 1b subcutaneously three times a week for 10 days.
Group name:Placebo Type of group
The placebo of INF-y 1b is administered subcutaneously three times a week for 10 days.
Sponsors
INTERMUNE PHARMACEUTICALS, INC.,
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: Coma. Kamofsky scale 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:CSF culture 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. Timepoints:2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:CSF culture 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. Timepoints:2 weeks | — |
Countries
Japan, Peru, United States
Outcome results
None listed