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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002068 |
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: Fluconazole Drug: Amphotericin B |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis |
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:
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 within 4 weeks of study entry:
Concurrent Treatment:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded within 4 weeks of study entry:
Prior Treatment:
Excluded:
Contacts and Locations| United States, California | |
| Davies Med Ctr | |
| San Francisco, California, United States, 94114 | |
| United States, Delaware | |
| Christiana Hosp / Med Ctr of Delaware | |
| Wilmington, Delaware, United States, 19899 | |
| United States, Florida | |
| Univ of South Florida | |
| Tampa, Florida, United States, 33612 | |
| United States, Maryland | |
| Univ of Maryland / Inst of Human Virology | |
| Baltimore, Maryland, United States, 212011192 | |
| United States, Michigan | |
| Henry Ford Hosp | |
| Detroit, Michigan, United States, 48202 | |
| United States, New York | |
| Harlem AIDS Treatment Group / Harlem Hosp Ctr | |
| New York, New York, United States, 10037 | |
| United States, Tennessee | |
| Univ of Tennessee | |
| Memphis, Tennessee, United States, 38163 | |
| Canada, Ontario | |
| Saint Michael's Hosp | |
| Toronto, Ontario, Canada | |
More Information
| ClinicalTrials.gov Identifier: | NCT00002068 History of Changes |
| Other Study ID Numbers: | 012H, 056-159B |
| 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 Drug Therapy, Combination |
Fluconazole Flucytosine 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 |