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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: |
NCT00002040 |
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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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Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
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Scientific title:
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Open, Non-Comparative Study of Intravenous and 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/NCT00002040 |
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Study type:
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Interventional |
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Study design:
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Masking: Open Label, 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:
- Antivirals 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.
- Patient's treatment status must be one of the following:
- No prior systemic antifungal therapy for cryptococcosis.
- Relapse after prior therapy. The success of prior therapy must have been documented
by negative 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 the study.
Prior Medication:
Allowed:
- Antivirals such as zidovudine (AZT). 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.
- A history of allergy to or intolerance of imidazoles or azoles.
- Moderate or severe liver disease defined by specified lab values.
- Life expectancy of < 2 weeks.
Concurrent Medication:
Excluded:
- Coumarin-type anticoagulants.
- Oral hypoglycemics.
- Barbiturates.
- Phenytoin.
- Immunostimulants.
- Investigational drugs or approved (licensed) drugs for investigational indications
except aerosolized pentamidine.
Concurrent Treatment:
Excluded:
- Lymphocyte replacement.
Patients with the following are excluded:
- Evidence of acute or chronic meningitis based upon any etiology other than
cryptococcosis.
- A history of allergy to or intolerance of imidazoles or azoles.
- Moderate or severe liver disease defined by specified lab values.
- Life expectancy of < 2 weeks.
Prior Medication:
Excluded:
- Coumarin-type anticoagulants.
- Oral hypoglycemics.
- Barbiturates.
- Phenytoin.
- Immunostimulants.
- Investigational drugs or approved (licensed) drugs for investigational indications
except aerosolized pentamidine.
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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012L
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056-164A
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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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