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Sponsored by: |
Pfizer |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002306 |
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.
Condition | Intervention |
---|---|
Meningitis, Cryptococcal HIV Infections |
Drug: Fluconazole |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Multi-Center Evaluation of Fluconazole (UK-49,858) as Treatment for Acute Cryptococcal Meningitis in Patients Who Have Failed to Respond or Have Experienced Unacceptable Toxicity During Treatment With Amphotericin B |
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Not previously treated for acute cryptococcal meningitis and not eligible for Pfizer Central Research, protocol #159.
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Concurrent Treatment:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
United States, Alabama | |
Univ of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, District of Columbia | |
George Washington Univ Med Ctr | |
Washington, District of Columbia, United States, 20037 | |
United States, Florida | |
Univ of South Florida | |
Tampa, Florida, United States, 33612 | |
United States, Georgia | |
Med College of Georgia | |
Augusta, Georgia, United States, 30912 | |
Emory Univ School of Medicine | |
Atlanta, Georgia, United States, 30303 | |
United States, Massachusetts | |
Univ Hosp | |
Boston, Massachusetts, United States, 02118 | |
United States, Michigan | |
Ann Arbor Veterans Administration Med Ctr | |
Ann Arbor, Michigan, United States, 48105 | |
United States, Missouri | |
Washington Univ School of Medicine | |
St. Louis, Missouri, United States, 63108 | |
United States, New York | |
Saint Luke's - Roosevelt Hosp Ctr | |
New York, New York, United States, 10025 | |
Bronx Veterans Administration / Mount Sinai Hosp | |
Bronx, New York, United States, 10468 | |
United States, Ohio | |
Cincinnati Veterans Adm Med Ctr / Univ Hosp | |
Cincinnati, Ohio, United States, 452670405 | |
United States, Texas | |
Univ TX San Antonio Health Science Ctr | |
San Antonio, Texas, United States, 78284 | |
Southwest Texas Methodist Hosp | |
San Antonio, Texas, United States, 78229 | |
United States Air Force Med Ctr | |
Lackland Air Force Base, Texas, United States, 782365300 |
Study ID Numbers: | 012I, 056-161 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002306 History of Changes |
Health Authority: | United States: Food and Drug Administration |
AIDS-Related Opportunistic Infections Meningitis Cryptococcosis |
Fluconazole Acquired Immunodeficiency Syndrome Amphotericin B |
Fluconazole Abelcet Anti-Infective Agents Amphotericin B Opportunistic Infections Meningitis, Fungal Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Central Nervous System Diseases Liposomal amphotericin B Immunologic Deficiency Syndromes Meningitis |
Virus Diseases Anti-Bacterial Agents Mycoses Central Nervous System Infections HIV Infections Antifungal Agents AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Meningitis, Cryptococcal Central Nervous System Fungal Infections Cryptococcosis Retroviridae Infections |
Abelcet Anti-Infective Agents Antiprotozoal Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Infection Liposomal amphotericin B Meningitis Anti-Bacterial Agents Mycoses Antiparasitic Agents Antifungal Agents Therapeutic Uses Antibiotics, Antifungal Meningitis, Cryptococcal |
Amebicides Central Nervous System Fungal Infections Retroviridae Infections Fluconazole Amphotericin B RNA Virus Infections Meningitis, Fungal Immune System Diseases Acquired Immunodeficiency Syndrome Nervous System Diseases Central Nervous System Diseases Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Central Nervous System Infections |