Multi-center Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
4 other identifiers
interventional
120
1 country
6
Brief Summary
To compare the safety and effectiveness of fluconazole (FCZ) and amphotericin B (AMB), alone or in combination with flucytosine (FLC), as treatment for acute cryptococcal meningitis in patients who have not been treated previously or who have relapsed after a previous successful treatment. Cryptococcal meningitis is an important cause of disease and death among patients with AIDS. Usually AMB is given either alone or with FLC to patients with this infection, but these treatments are not always effective and both have toxic effects. Animal studies and preliminary studies in humans show that FCZ is active in cryptococcal meningitis and suggest that it may be less toxic than either AMB or FLC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Primary Completion
Last participant's last visit for primary outcome
July 1, 1991
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedMarch 14, 2011
July 1, 1991
November 2, 1999
March 11, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Immunosuppressant therapy.
- Cyclosporin plasma concentrations should be monitored and appropriate dosage adjustments made when used with amphotericin B or fluconazole.
- Antiviral therapy.
- Prophylaxis for Pneumocystis carinii pneumonia.
- Treatment of intercurrent opportunistic infection as long as no investigational agent, or approved agent for an investigational indication, is used.
- Antipyretics, hydrocortisone, or meperidine to prevent or ameliorate side effects associated with amphotericin B.
- Concurrent Treatment:
- Allowed:
- \- Radiation therapy for mucocutaneous Kaposi's sarcoma.
- Patients must have:
- Written informed consent obtained from the patient or from the patient's legal guardian.
- One of the following:
- (1) Tentative identification of Cryptococcus neoformans in culture of lumbar cerebrospinal fluid (CSF). Results of baseline cultures need not be available when therapy is begun, but therapy is discontinued if the baseline CSF culture is later found to be negative for C. neoformans, or (2) Clinical and CSF findings (cell count, protein, glucose) compatible with cryptococcal meningitis plus one of the following:
- +9 more criteria
You may not qualify if:
- Co-existing Condition:
- Excluded:
- Acute or chronic meningitis based on any etiology other than cryptococcosis.
- History of allergy to or intolerance of imidazoles, or amphotericin B.
- Moderate or severe liver disease defined as any one or more of the following:
- SGOT or SGPT \> 5 x upper limit of normal, total bilirubin \> 2.5 mg/dl, prothrombin time \> 5 seconds over control, or alkaline phosphatase \> 2 x upper limit of normal.
- Comatose patients.
- Concurrent Medication:
- Excluded:
- Drugs with low therapeutic ratios that undergo hepatic metabolism may not be used with fluconazole until possible drug interactions have been clarified.
- Coumarin-type anticoagulants.
- Oral hypoglycemics.
- Barbiturates.
- Immunostimulants.
- Investigational drugs or approved (licensed) drugs for investigational indications.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, 10021, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, 10461, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
Related Publications (3)
Powderly WG. Recent advances in the management of cryptococcal meningitis in patients with AIDS. Clin Infect Dis. 1996 May;22 Suppl 2:S119-23. doi: 10.1093/clinids/22.supplement_2.s119.
PMID: 8722838BACKGROUNDPowderly WG, Cloud GA, Dismukes WE, Saag MS. Measurement of cryptococcal antigen in serum and cerebrospinal fluid: value in the management of AIDS-associated cryptococcal meningitis. Clin Infect Dis. 1994 May;18(5):789-92. doi: 10.1093/clinids/18.5.789.
PMID: 8075272BACKGROUNDSaag MS, Powderly WG, Cloud GA, Robinson P, Grieco MH, Sharkey PK, Thompson SE, Sugar AM, Tuazon CU, Fisher JF, et al. Comparison of amphotericin B with fluconazole in the treatment of acute AIDS-associated cryptococcal meningitis. The NIAID Mycoses Study Group and the AIDS Clinical Trials Group. N Engl J Med. 1992 Jan 9;326(2):83-9. doi: 10.1056/NEJM199201093260202.
PMID: 1727236BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Armstrong D
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Primary Completion
July 1, 1991
Last Updated
March 14, 2011
Record last verified: 1991-07