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
NCT ID: NCT00002074
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Fluconazole
Amphotericin B
Eligibility Criteria
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Inclusion Criteria
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).
Exclusion Criteria
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.
* Moderate or severe liver disease.
* Inability to take oral medications reliably.
Prior 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.
* Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.
Prior Treatment:
Excluded:
* Lymphocyte replacement.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Locations
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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
Chelsea Village Med Ctr
New York, New York, United States
Columbia Univ
New York, New York, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States
Bowman Gray School of Medicine / North Carolina Baptist Hosp
Winston-Salem, North Carolina, United States
Cincinnati Veterans Adm Med Ctr / Univ Hosp
Cincinnati, Ohio, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States
Univ TX Galveston Med Branch
Galveston, Texas, United States
United States Air Force Med Ctr
Lackland Air Force Base, Texas, United States
Southwest Texas Methodist Hosp
San Antonio, Texas, United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, United States
Richmond AIDS Consortium
Richmond, Virginia, United States
CHG-118 Group Health / Cooperative of Puget Sound
Seattle, Washington, United States
Dr Philip C Craven
Tacoma, Washington, United States
Saint Michael's Hosp
Toronto, Ontario, Canada
Countries
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References
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Powderly WG, Saag MS, Cloud GA, Robinson P, Meyer RD, Jacobson JM, Graybill JR, Sugar AM, McAuliffe VJ, Follansbee SE, et al. A controlled trial of fluconazole or amphotericin B to prevent relapse of cryptococcal meningitis in patients with the acquired immunodeficiency syndrome. The NIAID AIDS Clinical Trials Group and Mycoses Study Group. N Engl J Med. 1992 Mar 19;326(12):793-8. doi: 10.1056/NEJM199203193261203.
Saag 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.
Other Identifiers
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056-157
Identifier Type: -
Identifier Source: secondary_id
012D
Identifier Type: -
Identifier Source: org_study_id