PHASE III RANDOMIZED DOUBLE BLIND CONTROLLED WITH PLACEBO STUDY DOSAGE ABOUT THE SECURITY AND ANTIMICTIC ACTIVITY OF INTERFERON AND 1B (RIFN AND 1B) RECOMBINANT SUBCUTAIN IN COMBINATION WITH STANDARD THERAPY IN PATIENTS WITH ACUTE CRYTOCOCOCCAL MENINGITIS

Not Applicable

• Conditions: -G009 Bacterial meningitis, unspecified; Bacterial meningitis, unspecified; G009

• Registration Number: PER-026-00
• Lead Sponsor: INTERMUNE PHARMACEUTICALS, INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-04-18
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Having a first episode of cryptococcal meningitis documented either by cryptococcal positive culture, smear or positive ink (if the CSF culture for a patient is subsequently found negative the study medication will be discontinued and the follow-up will be terminated)
• Having a relapse of cryptococcal meningitis documented by a positive smear or ink (The presence of only the cryptococcal antigen is not sufficient.If the CSF culture of a patient is subsequently found negative, the study medication will be discontinued and the follow-up will be completed. )
• Not having received more than three doses (0.7 mg / Kg) of Amphotericin B or more than 1,200 mg of fluconazole or Itraconazole as a pre-treatment for this episode, and not having begun treatment for this episode more than 72 hours prior to initiation of the study medication (the patient may nevertheless have received fluconazole or Itraconazole in doses not exceeding 200 mg daily).
• Men and women 13 years of age or older. If you are under 18 years of age, the consent of one of the parents or guardians must be obtained.
• Patients or family members or guardians must have the ability to understand and sign a written informed consent form and to comply with the requirements of the study.
• Have aspartate aminotransferase (AST), alaninaminotransferase
• (ALT), Alkaline Phosphatase (ALP) # 10 times the upper limit of normal, bilirubin 2 times of the normal upper limit. Patients with chronic hepatitis B or 0 who have no clinical evidence of cirrhosis, liver enzymes, (AST, ALT grade 3 or greater) on at least 2 occasions, and a normal TP are eligible to participate.
• Serum creatinine <2 times of normal upper limit
• Absolute count of neutrophils (polymorphs and embroidered more than 1000 / mm3
• Hemoglobin greater than 7.0 gm / dL
• Platelet count greater than 50,000 / mm3
• There are no medications contraindicated with fluconazole or Itraconazole if they are intolerant to fluconazole

Exclusion Criteria

•Coma
• Pregnant women or those who are breastfeeding.
• Women with the potential to become pregnant who are not using a method of birth control. Female patients should have a serum beta-negative human chorionic gonadotropin test within 7 days of the study medication being initiated.
• History of hypersensitivity to imidazole or triazole components
• History of hypersensitivity to rlFN-ylb
• Requirement for concomitant nephrotoxic drugs other than amphotericin B.
• Administration of Erythropoietin or transfusions within 4 weeks of randomization
• Chronic administration of systemic corticosteroid therapy within 30 days prior to randomization or its requirement during the study.
• Have a history of clinically significant heart disease, including symptoms of ischemia,
• Have a history of multiple sclerosis, peripheral vascular disease or rheumatological disorders.
• Have a history of CNS disorder (not including the mode of disorders) as seizure disorders. Have concurrent disorders of the CNS which in the opinion of the investigator may interfere with the monitoring of adverse events or efficacy.
• Receive research therapy for C. neoformans within the
• 90 days prior to randomization
• Receive treatment with rlFN-y 1b within 90 days prior to randomization.
• Receive immunomodulatory therapy within 30 days prior to randomization
• Receive research therapy for other indications within 30 days prior to randomization
• Patients who, in the opinion of the researcher, are not suitable candidates for enrollment or do not comply with the requirements of the study.
• Have a chronic need for H2 blockers and can only receive itraconazole in phase 2.
• Manifestation or treatment of other serious opportunistic infections within 4 weeks of randomization.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:CSF examination<br>-Pressure of opening<br>-Cell phone<br>-Protein<br>-Glucose<br>-Cryptococcal infection (evaluated by Chinese ink, culture for fungi, and cryptococcal antigen [CRAG])<br>Measure:Efficacy<br>Timepoints:CSF exams will be performed during the screening, Phase 1 and at the end of the phase of chronic suppressive therapy of Phase 2.<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:The patient will record all the signs, symptoms and adverse events in a diary that will be used as an aid memory for the collection and registration of information in the CRF at the next visit. The newspaper will not be collected.<br>Measure:Safety<br>Timepoints:The duration of the study<br>