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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: |
NCT00002074 |
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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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Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Maintenance Treatment for the Prevention of Relapse of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome
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Scientific title:
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Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Maintenance Treatment for the Prevention of Relapse of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome |
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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/NCT00002074 |
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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:
- Antivirals such as zidovudine.
- Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia
(PCP).
- Pfizer must be notified if the patient is receiving ganciclovir (DHPG) at entry.
Concurrent Treatment:
Allowed:
- Radiation therapy for mucocutaneous Kaposi's sarcoma.
Patients must be oriented to person, place, and time, and able to give written informed
consent.
- Patients must have had an acute episode of cryptococcal meningitis that was
documented by recovery and identification of Cryptococcus neoformans from lumbar
cerebrospinal fluid (CSF) culture within 6 months prior to entry.
- Minimum total dose of 15 mg/kg of amphotericin B must have been given (either alone
or in combination with flucytosine) during primary therapy.
- Patients need not be receiving amphotericin B at the time of randomization but must
begin study maintenance therapy within 6 weeks of completion of primary amphotericin
B therapy. Patients may receive maintenance amphotericin B during the period between
completion of primary therapy and study entry.
Prior Medication:
Allowed:
- Antivirals such as zidovudine (AZT).
- Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia
(PCP).
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
- Clinical evidence of acute or chronic meningitis based upon any etiology other than
cryptococcosis.
- History of allergy or intolerance of imidazoles, azoles, or amphotericin B.
- Moderate or severe liver disease.
Concurrent Medication:
Excluded:
- Ketoconazole.
- Fluconazole.
- Itraconazole.
- Miconazole.
- Any systemic imidazole or azole for more than 7 days after initiation of primary
therapy for cryptococcosis.
- Intrathecal amphotericin B.
- Coumarin-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:
- Clinical evidence of acute or chronic meningitis based upon any etiology other than
cryptococcosis.
- History of allergy or intolerance of imidazoles, azoles, or amphotericin B.
- Moderate or severe liver disease.
- Inability to take oral medications reliably.
Prior Medication:
Excluded:
- Ketoconazole.
- Fluconazole.
- Itraconazole.
- Miconazole.
- Any systemic imidazole or azole for more than 7 days after initiation of primary
therapy for cryptococcosis.
- Intrathecal amphotericin B.
- Coumarin-type anticoagulants.
- Oral hypoglycemics.
- Barbiturates.
- Phenytoin.
- Immunostimulants.
- Investigational drugs or approved (licensed) drugs for investigational indications.
- Any exceptions to these prohibitions of concomitant medications must be approved by
Pfizer Central Research.
Prior Treatment:
Excluded:
- Lymphocyte replacement.
Age minimum:
18 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: Fluconazole
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Drug: Amphotericin B
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Secondary ID(s)
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012D
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056-157
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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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