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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: |
NCT00002076 |
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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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Pilot Study of Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
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Scientific title:
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Pilot Study of Oral Fluconazole in the Treatment of 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/NCT00002076 |
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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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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria
Concurrent Medication:
Allowed:
- Antiviral therapy such as zidovudine.
- Prophylaxis for Pneumocystis carinii pneumonia.
- Aerosolized pentamidine.
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.
- 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:
- 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, azoles, or amphotericin B.
- Moderate or severe liver disease defined by specified lab values.
- Patients who are unable to take oral medication.
- Unlikely to survive more than 2 weeks.
- Renal impairment.
Concurrent Medication:
Excluded:
- Coumarin-type anticoagulants.
- Oral hypoglycemics.
- Barbiturates.
- Phenytoin.
- Immunostimulants.
- Investigational drugs or approved (licensed) drugs for investigational indications
other than aerosolized pentamidine.
- Excluded within 4 weeks of study entry:
- Greater than 1 mg/kg/wk amphotericin B.
- Any exceptions to these prohibitions of concomitant medications must be approved by
Pfizer Central Research.
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 defined by specified lab values.
- Patients who are unable to take oral medication.
- Life expectancy of < 2 weeks.
- Any condition that may impair absorption of oral medication.
Prior Medication:
Excluded:
- Coumarin-type anticoagulants.
- Oral hypoglycemics.
- Barbiturates.
- Phenytoin.
- Immunostimulants.
- Investigational drugs or approved (licensed) drugs for investigational indications
other than aerosolized pentamidine.
- Excluded within 4 weeks of study entry:
- Greater than 1 mg/kg/wk amphotericin B.
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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Secondary ID(s)
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056-162
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012J
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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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