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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 Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about 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 conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. 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 Clinical research trials and 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 health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like 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. 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 Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a 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 clinical trial. Human subjects often get the best healthcare available for their 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 condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "M" Clinical Trials Conditions > 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 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
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
For Condition: Meningitis, Cryptococcal,HIV Infections
Status: Completed
Sponsor(s): Pfizer ,
Synopsis: To compare the safety and effectiveness of fluconazole and amphotericin B as maintenance treatment for preventing the relapse of cryptococcal meningitis in patients with AIDS.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: 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 Co-existing Condition: 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.
Total Enrollment:
Location and Contact Information:
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, 19899
United States
Emory Univ School of Medicine
Atlanta, Georgia, 30303
United States
Henry Ford Hosp
Detroit, Michigan, 48202
United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550
United States
United States Air Force Med Ctr
Lackland Air Force Base, Texas, 782365300
United States
Albany Med College / AIDS Treatment Ctr
Albany, New York, 12203
United States
Tucson Veterans Administration Med Ctr
Tucson, Arizona, 85724
United States
Southwest Texas Methodist Hosp
San Antonio, Texas, 78229
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Dr Paul Rothman
Sherman Oaks, California, 91403
United States
Univ of Florida College of Medicine
Gainesville, Florida, 32610
United States
Ann Arbor Veterans Administration Med Ctr
Ann Arbor, Michigan, 48105
United States
Jewish Hosp Ctr Affiliation
Jamaica, New York, 11432
United States
Chelsea Village Med Ctr
New York City, New York, 10014
United States
Richmond AIDS Consortium
Richmond, Virginia, 23219
United States
Shallowford Hosp
Decatur, Georgia, 30033
United States
Saint Michael's Hosp
Toronto, Ontario,
Canada
Dr Richard Meyer
Los Angeles, California, 90048
United States
CHG-118 Group Health / Cooperative of Puget Sound
Seattle, Washington, 98112
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Saint Michael's Med Ctr
Newark, New Jersey, 07102
United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 78284
United States
Dr Michael Bach
Portland, Maine, 04102
United States
Cincinnati Veterans Adm Med Ctr / Univ Hosp
Cincinnati, Ohio, 452670405
United States
Univ Hosp
Boston, Massachusetts, 02118
United States
New England Med Ctr
Boston, Massachusetts, 02111
United States
Harper Hosp
Detroit, Michigan, 48201
United States
Univ of Maryland / Inst of Human Virology
Baltimore, Maryland, 212011192
United States
Cabrini Med Ctr
New York City, New York, 10003
United States
Med College of Georgia
Augusta, Georgia, 30912
United States
Columbia Univ
New York City, New York, 10032
United States
Bowman Gray School of Medicine / North Carolina Baptist Hosp
Winston Salem, North Carolina, 27103
United States
Davies Med Ctr
San Francisco, California, 94114
United States
DeKalb Gen Hosp
Decatur, Georgia, 30033
United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
United States
Dr Philip C Craven
Tacoma, Washington, 98405
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Univ of South Florida
Tampa, Florida, 33612
United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York City, New York, 10037
United States
Additional Information:
Study ID Numbers: 012D; 056-157
Study Start Date:
Record last reviewed: May 1990
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002074
Other Meningitis, Cryptococcal Studies:
1. A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment
2. The Safety and Effectiveness of 524W91
3. A Study of Immune System Activity in Healthy Adults
4. A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on their First PI-Based Antiretroviral Therapy
5. A Double-Blind Study To Evaluate the Long-Term Safety and Effectiveness of 60 mg Versus 120 mg of Aerosol Pentamidine in the Prophylaxis of Pneumocystis carinii Pneumonia in AIDS Patients
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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
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