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).

INTERMUNE PHARMACEUTICALS, INC.,0 sites0 target enrollmentMarch 25, 2003

Overview

No summary available.

Registry

who.int

Start Date

March 25, 2003

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

INTERMUNE PHARMACEUTICALS, INC.,

•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.

•1\. Stroke.
•2\. Karnofsky scale \<30\.
•3\. Life expectancy \<2 weeks.
•4\. 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 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.

Not specified