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

Study Overview
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Brief Summary
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To compare the safety and effectiveness of fluconazole and amphotericin B as maintenance treatment for preventing the relapse of cryptococcal meningitis in patients with AIDS.

Official 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

Conditions
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Meningitis, Cryptococcal, HIV Infections

Intervention / Treatment
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* Drug: Fluconazole
* Drug: Amphotericin B


Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fluconazole|nan|
|Drug: Amphotericin B|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Fluconazole, Acquired Immunodeficiency Syndrome, Amphotericin B