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Sponsored by: |
Pfizer |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002068 |
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: | Treatment |
Official Title: | A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis |
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:
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 |
Study ID Numbers: | 012H, 056-159B |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002068 |
Health Authority: | United States: Food and Drug Administration |
AIDS-Related Opportunistic Infections Meningitis Cryptococcosis Drug Therapy, Combination |
Fluconazole Flucytosine Acquired Immunodeficiency Syndrome Amphotericin B |
Fluconazole Abelcet Amphotericin B Opportunistic Infections Meningitis, Fungal Sexually Transmitted Diseases, Viral Clotrimazole Miconazole Acquired Immunodeficiency Syndrome Tioconazole Central Nervous System Diseases Flucytosine |
Liposomal amphotericin B Immunologic Deficiency Syndromes Meningitis Virus Diseases Mycoses Central Nervous System Infections HIV Infections AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Meningitis, Cryptococcal Cryptococcosis Retroviridae Infections |
Anti-Infective Agents RNA Virus Infections Antiprotozoal Agents Slow Virus Diseases Immune System Diseases Nervous System Diseases Infection Pharmacologic Actions |
Anti-Bacterial Agents Antiparasitic Agents Antifungal Agents Therapeutic Uses Antibiotics, Antifungal Lentivirus Infections Central Nervous System Fungal Infections Amebicides |