A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
2 other identifiers
interventional
N/A
2 countries
8
Brief Summary
To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
February 1, 1990
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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.
- +2 more criteria
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.
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (8)
Davies Med Ctr
San Francisco, California, 94114, United States
Christiana Hosp / Med Ctr of Delaware
Wilmington, Delaware, 19899, United States
Univ of South Florida
Tampa, Florida, 33612, United States
Univ of Maryland / Inst of Human Virology
Baltimore, Maryland, 212011192, United States
Henry Ford Hosp
Detroit, Michigan, 48202, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, 10037, United States
Univ of Tennessee
Memphis, Tennessee, 38163, United States
Saint Michael's Hosp
Toronto, Ontario, Canada