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

Completed · Not applicable

Conditions studied: Meningitis, Cryptococcal, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002074

Run by

Pfizer

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• Tucson Veterans Administration Med Ctr — Tucson, Arizona, United States
• Dr Richard Meyer — Los Angeles, California, United States
• Davies Med Ctr — San Francisco, California, United States
• Dr Paul Rothman — Sherman Oaks, California, United States
• Wilmington Hosp / Med Ctr of Delaware — Wilmington, Delaware, United States
• George Washington Univ Med Ctr — Washington D.C., District of Columbia, United States
• Univ of Florida College of Medicine — Gainesville, Florida, United States
• Univ of South Florida — Tampa, Florida, United States
• Emory Univ School of Medicine — Atlanta, Georgia, United States
• Med College of Georgia — Augusta, Georgia, United States
• DeKalb Gen Hosp — Decatur, Georgia, United States
• Shallowford Hosp — Decatur, Georgia, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• Dr Michael Bach — Portland, Maine, United States
• Univ of Maryland / Inst of Human Virology — Baltimore, Maryland, United States
• New England Med Ctr — Boston, Massachusetts, United States
• Univ Hosp — Boston, Massachusetts, United States
• Ann Arbor Veterans Administration Med Ctr — Ann Arbor, Michigan, United States
• Harper Hosp — Detroit, Michigan, United States
• Henry Ford Hosp — Detroit, Michigan, United States
• Saint Michael's Med Ctr — Newark, New Jersey, United States
• Albany Med College / AIDS Treatment Ctr — Albany, New York, United States
• Jewish Hosp Ctr Affiliation — Jamaica, New York, United States
• Cabrini Med Ctr — New York, New York, United States

Full record on ClinicalTrials.gov

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