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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002306 |
Purpose
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: | Primary Purpose: 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 |
Eligibility| 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:
Contacts and Locations| 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 | |
| Emory Univ School of Medicine | |
| Atlanta, Georgia, United States, 30303 | |
| Med College of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| 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 | |
| Bronx Veterans Administration / Mount Sinai Hosp | |
| Bronx, New York, United States, 10468 | |
| Saint Luke's - Roosevelt Hosp Ctr | |
| New York, New York, United States, 10025 | |
| United States, Ohio | |
| Cincinnati Veterans Adm Med Ctr / Univ Hosp | |
| Cincinnati, Ohio, United States, 452670405 | |
| United States, Texas | |
| United States Air Force Med Ctr | |
| Lackland Air Force Base, Texas, United States, 782365300 | |
| Southwest Texas Methodist Hosp | |
| San Antonio, Texas, United States, 78229 | |
| Univ TX San Antonio Health Science Ctr | |
| San Antonio, Texas, United States, 78284 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00002306 History of Changes |
| Other Study ID Numbers: | 012I, 056-161 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
AIDS-Related Opportunistic Infections Meningitis Cryptococcosis |
Fluconazole Acquired Immunodeficiency Syndrome Amphotericin B |
|
HIV Infections Acquired Immunodeficiency Syndrome Meningitis Meningitis, Cryptococcal Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Central Nervous System Infections Central Nervous System Diseases |
Nervous System Diseases Meningitis, Fungal Central Nervous System Fungal Infections Mycoses Cryptococcosis Amphotericin B Liposomal amphotericin B Fluconazole Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents |