A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute 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
- NCT00002068
- Run by
- Pfizer
- Last updated by the study team
- 2005-06-24
Who can join
Age: 13 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.
- Concurrent Medication:
- Excluded within 4 weeks of study entry:
- Greater than 1 mg/kg/wk amphotericin B.
- Coumadin-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:
- 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.
Where it is running
- Davies Med Ctr — San Francisco, California, United States
- Christiana Hosp / Med Ctr of Delaware — Wilmington, Delaware, United States
- Univ of South Florida — Tampa, Florida, United States
- Univ of Maryland / Inst of Human Virology — Baltimore, Maryland, United States
- Henry Ford Hosp — Detroit, Michigan, United States
- Harlem AIDS Treatment Group / Harlem Hosp Ctr — New York, New York, United States
- Univ of Tennessee — Memphis, Tennessee, United States
- Saint Michael's Hosp — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
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