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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: |
NCT00002113 |
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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 Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis.
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Scientific title:
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A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With 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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64 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00002113 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, 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 (AZT, DHPG).
- Prophylaxis for Pneumocystis carinii pneumonia.
- Treatment for intercurrent opportunistic infection.
Concurrent Treatment:
Allowed:
- Radiation therapy for mucocutaneous Kaposi's sarcoma.
Patients must have:
- AIDS.
- Evidence of Cryptococcal neoformans in culture or lumbar CSF OR clinical and CSF
findings compatible with cryptococcal meningitis.
- No evidence of acute or chronic meningitis of any etiology other than cryptococcosis.
- Life expectancy of at least 2 weeks.
Prior Medication:
Allowed:
- Prior antiviral therapy (AZT, DHPG).
- Prophylaxis for Pneumocystis carinii pneumonia.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Relapsing on maintenance triazole therapy for cryptococcal meningitis.
- Unable to take oral medication.
Concurrent Medication:
Excluded:
- Concomitant use of any antifungal agent other than study drug.
Patients with the following prior conditions are excluded:
History of allergy to or intolerance of imidazoles, azoles, or flucytosine.
Prior Medication:
Excluded:
- More than 1 mg/kg amphotericin B.
- Systemic antifungal agents within 7 days prior to study entry.
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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Meningitis, Cryptococcal
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HIV Infections
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Intervention(s)
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Drug: Flucytosine
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Drug: Fluconazole
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Secondary ID(s)
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213A
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R-0202
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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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