A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis

Completed · Not applicable

Conditions studied: Meningitis, Cryptococcal, HIV Infections

In brief

To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis.

Key facts

Study ID

NCT00002305

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:
• Immunosuppressant therapy.
• Antiviral therapy such as zidovudine.
• Prophylaxis for Pneumocystis carinii pneumonia.
• Concurrent Treatment:
• Allowed:
• Radiation therapy for mucocutaneous Kaposi's sarcoma.
• Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.
• No prior systemic antifungal therapy for cryptococcosis.
• Relapse after prior therapy.
• Success of prior therapy must have been documented by negative cerebrospinal fluid (CSF) culture at the end of therapy. Following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin B in the 4 weeks before entry into study.
• Prior Medication:
• Allowed:
• Immunosuppressant therapy.
• Antiviral therapy (such as zidovudine).
• Prophylaxis for Pneumocystis carinii pneumonia.

You may not qualify if…

• Co-existing Condition:
• Patients with the following are excluded:
• Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
• History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.
• Moderate or severe liver disease.
• Comatose.
• Unlikely to survive more than 2 weeks.
• Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.
• Concurrent Medication:
• Excluded:
• Coumadin-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.
• Excluded within 4 weeks of study entry:
• Greater than 1 mg/kg/wk amphotericin B.
• Concurrent Treatment:
• Excluded:
• Lymphocyte replacement.
• Patients with the following are excluded:
• Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
• History of allergy to 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
• UCLA CARE Ctr — Los Angeles, California, United States
• Dr Shelly Gordon — San Francisco, California, United States
• Dr Martin Mass — San Francisco, California, United States
• Dr Paul Rothman — Sherman Oaks, California, United States
• Christiana Hosp / Med Ctr of Delaware — Wilmington, Delaware, United States
• George Washington Univ Med Ctr — Washington D.C., District of Columbia, United States
• Univ of Miami School of Medicine — Miami, 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
• Northwestern Univ Med School — Chicago, Illinois, United States
• Louisiana State Univ School of Medicine — New Orleans, Louisiana, United States
• Tulane Univ School of Medicine — New Orleans, Louisiana, United States
• Dr Michael Bach — Portland, Maine, United States
• Univ of Maryland / Inst of Human Virology — Baltimore, Maryland, United States
• Loch Raven Veterans Hosp — 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
• Washington Univ School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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