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Home > "A" Clinical Trials Conditions > A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis  A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis
A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis
For Condition: Meningitis, Cryptococcal,HIV Infections
Status: Completed
Sponsor(s): Pfizer ,
Synopsis: To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria 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. Exclusion Criteria 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. - Moderate or severe liver disease. - Comatose. - Unlikely to survive more than 2 weeks. Prior Medication: Excluded: - Coumadin-type anticoagulants. - Oral hypoglycemics. - Barbiturates. - Phenytoin. - Immunostimulants. - Investigational drugs or approved (licensed) drugs for investigational indications. - Excluded within 4 weeks of study entry: - Greater than 1 mg/kg/wk amphotericin B. Prior Treatment: Excluded: - Lymphocyte replacement.
Total Enrollment:
Location and Contact Information:
Univ of Tennessee
Memphis, Tennessee, 38163
United States
Albany Med College / AIDS Treatment Ctr
Albany, New York, 12203
United States
Univ Hosp
Boston, Massachusetts, 02118
United States
Harper Hosp
Detroit, Michigan, 48201
United States
Ann Arbor Veterans Administration Med Ctr
Ann Arbor, Michigan, 48105
United States
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, 275997215
United States
Louisiana State Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Chelsea Village Med Ctr
New York City, New York, 10014
United States
Richmond AIDS Consortium
Richmond, Virginia, 23219
United States
Ohio State Univ Hosp
Columbus, Ohio, 43210
United States
Loch Raven Veterans Hosp
Baltimore, Maryland, 21218
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
United States Air Force Med Ctr
Lackland Air Force Base, Texas, 782365300
United States
New England Med Ctr
Boston, Massachusetts, 02111
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Saint Michael's Hosp
Toronto, Ontario,
Canada
Tucson Veterans Administration Med Ctr
Tucson, Arizona, 85724
United States
Cincinnati Veterans Adm Med Ctr / Univ Hosp
Cincinnati, Ohio, 452670405
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Dr Michael Bach
Portland, Maine, 04102
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Univ of South Florida
Tampa, Florida, 33612
United States
Henry Ford Hosp
Detroit, Michigan, 48202
United States
CHG-118 Group Health / Cooperative of Puget Sound
Seattle, Washington, 98112
United States
Columbia Univ
New York City, New York, 10032
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Med College of Georgia
Augusta, Georgia, 30912
United States
Dr Martin Mass
San Francisco, California, 94120
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Jewish Hosp Ctr Affiliation
Jamaica, New York, 11432
United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Bronx Veterans Administration / Mount Sinai Hosp
Bronx, New York, 10468
United States
DeKalb Gen Hosp
Decatur, Georgia, 30033
United States
Dr Shelly Gordon
San Francisco, California, 94115
United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York City, New York, 10037
United States
Christiana Hosp / Med Ctr of Delaware
Wilmington, Delaware, 19899
United States
Emory Univ School of Medicine
Atlanta, Georgia, 30303
United States
Univ of Maryland / Inst of Human Virology
Baltimore, Maryland, 212011192
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Washington Univ School of Medicine
St. Louis, Missouri, 63108
United States
Dr Paul Rothman
Sherman Oaks, California, 91403
United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 78284
United States
Dr Daniel Barbaro
Dallas, Texas, 75235
United States
Additional Information:
Study ID Numbers: 012F; 056-159
Study Start Date:
Record last reviewed: December 1989
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002305
Other Hiv Infections Studies:
1. A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 mg) or Rifabutin (300 mg) or Placebo
2. An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4.
3. Interleukin 12 (IL-12) for the Treatment of Cryptosporidiosis in AIDS Patients
4. Safety and Effectiveness of Giving SU5416 to HIV-Infected Patients with AIDS-Related Kaposi's Sarcoma
5. Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients with AIDS-Related Progressive Multifocal Leukoencephalopathy (PML)
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A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis
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