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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002305 |
Purpose
To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis.
| Condition | Intervention |
|---|---|
|
Meningitis, Cryptococcal HIV Infections |
Drug: Flucytosine Drug: Fluconazole Drug: Amphotericin B |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arizona | |
| Tucson Veterans Administration Med Ctr | |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| UCLA CARE Ctr | |
| Los Angeles, California, United States, 90095 | |
| Dr Paul Rothman | |
| Sherman Oaks, California, United States, 91403 | |
| Dr Martin Mass | |
| San Francisco, California, United States, 94120 | |
| Dr Shelly Gordon | |
| San Francisco, California, United States, 94115 | |
| United States, Delaware | |
| Christiana Hosp / Med Ctr of Delaware | |
| Wilmington, Delaware, United States, 19899 | |
| United States, District of Columbia | |
| George Washington Univ Med Ctr | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 331361013 | |
| Univ of South Florida | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| DeKalb Gen Hosp | |
| Decatur, Georgia, United States, 30033 | |
| Med College of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| Emory Univ School of Medicine | |
| Atlanta, Georgia, United States, 30303 | |
| United States, Illinois | |
| Northwestern Univ Med School | |
| Chicago, Illinois, United States, 60611 | |
| United States, Louisiana | |
| Tulane Univ School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| Louisiana State Univ School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maine | |
| Dr Michael Bach | |
| Portland, Maine, United States, 04102 | |
| United States, Maryland | |
| Loch Raven Veterans Hosp | |
| Baltimore, Maryland, United States, 21218 | |
| Univ of Maryland / Inst of Human Virology | |
| Baltimore, Maryland, United States, 212011192 | |
| United States, Massachusetts | |
| New England Med Ctr | |
| Boston, Massachusetts, United States, 02111 | |
| Univ Hosp | |
| Boston, Massachusetts, United States, 02118 | |
| United States, Michigan | |
| Henry Ford Hosp | |
| Detroit, Michigan, United States, 48202 | |
| Harper Hosp | |
| Detroit, Michigan, United States, 48201 | |
| 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 | |
| Montefiore Med Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10467 | |
| Bronx Veterans Administration / Mount Sinai Hosp | |
| Bronx, New York, United States, 10468 | |
| Mem Sloan - Kettering Cancer Ctr | |
| New York, New York, United States, 10021 | |
| Jewish Hosp Ctr Affiliation | |
| Jamaica, New York, United States, 11432 | |
| Chelsea Village Med Ctr | |
| New York, New York, United States, 10014 | |
| Harlem AIDS Treatment Group / Harlem Hosp Ctr | |
| New York, New York, United States, 10037 | |
| Albany Med College / AIDS Treatment Ctr | |
| Albany, New York, United States, 12203 | |
| Columbia Univ | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Univ of North Carolina School of Medicine | |
| Chapel Hill, North Carolina, United States, 275997215 | |
| United States, Ohio | |
| Cincinnati Veterans Adm Med Ctr / Univ Hosp | |
| Cincinnati, Ohio, United States, 452670405 | |
| Ohio State Univ Hosp | |
| Columbus, Ohio, United States, 43210 | |
| United States, Tennessee | |
| Univ of Tennessee | |
| Memphis, Tennessee, United States, 38163 | |
| United States, Texas | |
| United States Air Force Med Ctr | |
| Lackland Air Force Base, Texas, United States, 782365300 | |
| Dr Daniel Barbaro | |
| Dallas, Texas, United States, 75235 | |
| Univ TX San Antonio Health Science Ctr | |
| San Antonio, Texas, United States, 78284 | |
| Univ TX Galveston Med Branch | |
| Galveston, Texas, United States, 77550 | |
| United States, Virginia | |
| Richmond AIDS Consortium | |
| Richmond, Virginia, United States, 23219 | |
| United States, Washington | |
| CHG-118 Group Health / Cooperative of Puget Sound | |
| Seattle, Washington, United States, 98112 | |
| Canada, Ontario | |
| Saint Michael's Hosp | |
| Toronto, Ontario, Canada | |
More Information
| Study ID Numbers: | 012F, 056-159 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002305 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
AIDS-Related Opportunistic Infections Meningitis Cryptococcosis Drug Therapy, Combination |
Fluconazole Flucytosine Acquired Immunodeficiency Syndrome Amphotericin B |
|
Antimetabolites Abelcet Anti-Infective Agents Communicable Diseases Antiprotozoal Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Flucytosine 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 |