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

Official Title: “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”

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.

Intervention(s) in this Clinical Trial

• Drug: Fluconazole
• Drug: Amphotericin B

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002074

Study ID Number: 012D

ClinicalTrials.gov Identifier: NCT00002074

Health Authority: United States: Food and Drug Administration