|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00002306 |
|
Date of registration:
|
02/11/1999 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success With Amphotericin B
|
|
Scientific title:
|
Multi-Center Evaluation of Fluconazole (UK-49,858) as Treatment for Acute Cryptococcal Meningitis in Patients Who Have Failed to Respond or Have Experienced Unacceptable Toxicity During Treatment With Amphotericin B |
|
Date of first enrolment:
|
October 1997 |
|
Target sample size:
|
|
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00002306 |
|
Study type:
|
Interventional |
|
Study design:
|
Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria
Concurrent Medication:
Allowed:
- Immunosuppressant therapy.
- Antiviral therapy such as zidovudine.
- Prophylaxis for Pneumocystis carinii pneumonia.
- Aerosolized pentamidine.
Concurrent Treatment:
Allowed:
- Radiation therapy for mucocutaneous Kaposi's sarcoma.
Not previously treated for acute cryptococcal meningitis and not eligible for Pfizer
Central Research, protocol #159.
- Patients must have a baseline cerebrospinal fluid (CSF) culture-positive for
Cryptococcus neoformans.
- Written informed consent must be obtained for each patient, either from the patient
himself or from the patient's legal guardian.
- Each individual patient must be approved by Pfizer Central Research prior to study
entry.
Prior Medication:
Allowed:
- Immunosuppressant therapy.
- Antiviral therapy such as zidovudine.
- Prophylaxis for Pneumocystis carinii pneumonia.
- Aerosolized pentamidine.
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
- Evidence of acute or chronic meningitis based upon any etiology other than
cryptococcosis.
- History of allergy to or intolerance of imidazoles or azoles.
- Moderate or severe liver disease.
Concurrent Treatment:
Excluded:
- Lymphocyte replacement.
Patients with the following are excluded:
- Evidence of acute or chronic meningitis based upon any etiology other than
cryptococcosis.
- History of allergy to or intolerance of imidazoles or azoles.
- Moderate or severe liver disease.
- Satisfactory response to amphotericin B and have received a total amphotericin B dose
of 15 mg/kg or more since CSF culture documentation of the current episode of acute
cryptococcal meningitis.
- Life expectancy of < 2 weeks.
Prior Medication:
Excluded:
- Coumadin-type anticoagulants.
- Oral hypoglycemics.
- Barbiturates.
- Phenytoin.
- Immunostimulants.
- Investigational drugs or approved (licensed) drugs for investigational indications.
Prior Treatment:
Excluded:
- Lymphocyte replacement.
Age minimum:
13 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
HIV Infections
|
|
Meningitis, Cryptococcal
|
|
Intervention(s)
|
|
Drug: Fluconazole
|
|
Secondary ID(s)
|
|
012I
|
|
056-161
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|