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Home > "A" Clinical Trials Conditions > A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success with Amphotericin B  A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success with Amphotericin B
A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success with Amphotericin B
For Condition: Meningitis, Cryptococcal,HIV Infections
Status: Completed
Sponsor(s): Pfizer ,
Synopsis: To evaluate the safety and effectiveness of fluconazole as treatment for acute cryptococcal meningitis in patients who have had an unsatisfactory response to or have experienced unacceptable toxicity with amphotericin B.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Immunosuppressant therapy. - Antiviral therapy such as zidovudine. - Prophylaxis for Pneumocystis carinii pneumonia. - Aerosolized pentamidine. Concurrent Treatment: Allowed: - Radiation therapy for mucocutaneous Kaposi's sarcoma. Not previously treated for acute cryptococcal meningitis and not eligible for Pfizer Central Research, protocol #159. - Patients must have a baseline cerebrospinal fluid (CSF) culture-positive for Cryptococcus neoformans. - Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian. - Each individual patient must be approved by Pfizer Central Research prior to study entry. Prior Medication: Allowed: - Immunosuppressant therapy. - Antiviral therapy such as zidovudine. - Prophylaxis for Pneumocystis carinii pneumonia. - Aerosolized pentamidine. 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 or azoles. - Moderate or severe liver disease. 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 or azoles. - Moderate or severe liver disease. - Satisfactory response to amphotericin B and have received a total amphotericin B dose of 15 mg/kg or more since CSF culture documentation of the current episode of acute cryptococcal meningitis. - Life expectancy of < 2 weeks. Prior Medication: Excluded: - Coumadin-type anticoagulants. - Oral hypoglycemics. - Barbiturates. - Phenytoin. - Immunostimulants. - Investigational drugs or approved (licensed) drugs for investigational indications. Prior Treatment: Excluded: - Lymphocyte replacement.
Total Enrollment:
Location and Contact Information:
Ann Arbor Veterans Administration Med Ctr
Ann Arbor, Michigan, 48105
United States
United States Air Force Med Ctr
Lackland Air Force Base, Texas, 782365300
United States
Southwest Texas Methodist Hosp
San Antonio, Texas, 78229
United States
Cincinnati Veterans Adm Med Ctr / Univ Hosp
Cincinnati, Ohio, 452670405
United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 78284
United States
Univ of South Florida
Tampa, Florida, 33612
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Univ Hosp
Boston, Massachusetts, 02118
United States
Bronx Veterans Administration / Mount Sinai Hosp
Bronx, New York, 10468
United States
Emory Univ School of Medicine
Atlanta, Georgia, 30303
United States
Washington Univ School of Medicine
St. Louis, Missouri, 63108
United States
Med College of Georgia
Augusta, Georgia, 30912
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Additional Information:
Study ID Numbers: 012I; 056-161
Study Start Date:
Record last reviewed: February 1990
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002306
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2. Vitamin B Therapy for Hyperlactatemia
3. Male Circumcision and HIV Rates in Kenya
4. Prediction and Testing of Antigenic Sites of the AIDS Virus, HTLV-III Recognized by T Lymphocytes for the Development of Synthetic Vaccines
5. An HIV Vaccine Preparedness Study
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A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success with Amphotericin B
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