None listed
Conditions
Interventions
The active treatment group will receive subcutaneous IFN-y 1b at a dose of 1.5 ug / kg (0.0075 mL / kg) if the body surface area (BSA) 0.5 m2 three times a week for 10 weeks.
Group name:Placebo Type of group
The placebo group will receive placebo that matches the active drug in a volume of 0.0075 mL / kg if BSA 0.5 m2 subcutaneously (SC) three times per week for 10 weeks.
Sponsors
INTERMUNE PHARMACEUTICALS, INC.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Known diagnosis of infection by human immunodeficiency virus (HIV). Patients with a history of behavior at high risk of HIV infection can enroll in the study before receiving the results of the HIV antibody tests at the central laboratory. 2. Diagnosis of an acute episode of primary cryptococcal meningitis or relapse documented by the growth of Cryptococcus neoformans in a culture of CSF, if the result of the culture is available at the time of randomization, either by a preparation of positive Chinese ink for C. neoformans, or a positive test of cryptococcal CSF antigen.
Exclusion criteria
Exclusion criteria: 1. Stroke. 2. Karnofsky scale 1.0 mg / kg / d) of amphotericin B deoxycholate, or more than 18 mg / kg (or more than three doses daily> 4-6 mg / kg / d) of an amphotericin B formulation based on lipids, or more than 1200 mg (or more than three daily doses> 400 mg / d) of fluconazole or itraconazole. 5. Start of treatment for this event more than 72 hours before the start of the study medication. (However, patients may have received fluconazole or itraconazole at doses no higher than 200 mg daily before entering the study). 6. Concurrent and active infection of the central nervous system! (CNS) or malignant CNS picture. 7. Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Cultivation in LCR Measure:The 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:Cultivation in LCR Measure:Effect of therapy with IFN-y Ib, together with the concomitant standard antifungal therapy, on: conversion rate of culture in CSF to negative at 2 weeks Timepoints:2 weeks | — |
Countries
Peru, United States
Outcome results
None listed