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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00002068 |
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Date of registration:
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02/11/1999 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
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Scientific title:
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A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis |
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Date of first enrolment:
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January 1976 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00002068 |
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Study type:
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Interventional |
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Study design:
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Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Canada
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria
Concurrent Medication:
Allowed:
- Immunosuppressant therapy.
- Antiviral therapy such as zidovudine.
- Prophylaxis for Pneumocystis carinii pneumonia.
Concurrent Treatment:
Allowed:
- Radiation therapy for mucocutaneous Kaposi's sarcoma.
Written informed consent must be obtained for each patient, either from the patient
himself or from the patient's legal guardian.
- No prior systemic antifungal therapy for cryptococcosis.
- Relapse after prior therapy.
- Success of prior therapy must have been documented by negative cerebrospinal fluid
(CSF) culture at the end of therapy. Following prior therapy, such patients may not
have received more than 1 mg/kg/wk amphotericin B in the 4 weeks before entry into
study.
Prior Medication:
Allowed:
- Immunosuppressant therapy.
- Antiviral therapy such as zidovudine.
- Prophylaxis for Pneumocystis carinii pneumonia.
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, azoles, or amphotericin B.
- Moderate or severe liver disease.
- Comatose.
- Unlikely to survive more than 2 weeks.
Concurrent Medication:
Excluded within 4 weeks of study entry:
- Greater than 1 mg/kg/wk amphotericin B.
- Coumadin-type anticoagulants.
- Oral hypoglycemics.
- Barbiturates.
- Phenytoin.
- Immunostimulants.
- Investigational drugs or approved (licensed) drugs for investigational indications.
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, azoles, or amphotericin B.
- Moderate or severe liver disease.
- Comatose.
- Unlikely to survive more than 2 weeks.
Prior Medication:
Excluded within 4 weeks of study entry:
- Greater than 1 mg/kg/wk amphotericin B.
- 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
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Meningitis, Cryptococcal
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Intervention(s)
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Drug: Fluconazole
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Drug: Amphotericin B
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Secondary ID(s)
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012H
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056-159B
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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