PHASE III RANDOMIZED DOUBLE-BLIND CONTROLLED STUDY WITH PLACEBO 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 CRYTOCOCCAL MENINGITIS
- Conditions
- -G039 Meningitis, unspecifiedMeningitis, unspecifiedG039
- Registration Number
- PER-024-00
- Lead Sponsor
- INTERMUNE PHARMACEUTICALS, INC.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Having a first episode of cryptococcal meningitis documented either by cryptococcus positive culture, smear or positive ink (if the CSF culture for a patient is consecutively 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 the 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) greater than or equal to 10 times the upper limit of normal, bilirubin times the upper limit of normal. Patients with chronic hepatitis B or C who do not have clinical evidence of cirrhosis, liver enzymes (AST, ALT grade 3 or greater) at least 2 occasions and a normal PT are eligible to participate.
• Serum creatinine <2 times of normal upper limit
• Absolute count of neutrophils (polymorphs and embryonated cells greater than or equal to 1000 / mm3
• Hemoglobin greater than 7.0 gm / dL
• Platelet count greater than or equal to 50,000 / mm3
• Coma
• Pregnant women or those who are breastfeeding.
• Women with the potential to become pregnant who are not using an effective method of birth control. Female patients should have a serum test of the human chorionic gonadotropin hormone beta fraction within 7 days of the start of study medication.
• History of hypersensitivity to imidazole or triazole components
• History of hypersensitivity to rIFN-Ylb
• Requirement for concomitant nephrotoxic drugs other than amphotericin B.
• Administration of Erythropoietin or transfusions within 4 weeks of randomization
• Patients who are receiving chronic systemic therapy with corticosteroids within 30 days prior to randomization or who require it during the study.
• Have a history of clinically significant heart disease, including symptoms of Ischemia, coronary artery disease, congestive heart failure or arrhythmia
• Have a history of multiple sclerosis, peripheral vascular disease or rheumatological disorders.
• Have a history of disturbance in the CNS (not including mood disturbances) as seizure disorders. Concomitantly CNS alterations, which in the opinion of the investigator may interfere with the evaluation of adverse events or efficacy.
• Receive research therapy for C. neoformans within 90 days prior to randomization.
• Receive treatment with riFN-y 1 b 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 investigator, are not suitable candidates for enrollment or may not meet the requirements of the study.
• Have a requirement for H2 blockers chronically and that can only receive itraconazole in phase 2.
• Manifestation or treatment of other serious opportunistic acute 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 exam<br>- Opening pressure<br>- Cell counting<br>- Protein<br>- Glucose<br>- Cryptococcal infection (evaluated by Chinese ink, culture for fungi and cryptococcal antigen [CRAGJ]<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>The cryptococcal serum antigen will be performed during the screening, at the end of Phase 1, at the end of the Phase 2 suppressive chronic phase and on day 98<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:All patients who receive at least one dose of study medication will be included in the safety and tolerance analysis. After discharge, the patient will continue to receive the study medication on an outpatient basis. All the signs, symptoms and adverse events of the patient will be recorded in a diary that will be used as a memory of help for the collection and registration of the 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>