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Sponsored by: |
Pfizer |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002077 |
To evaluate the safety and effectiveness of fluconazole as an intravenous dose as initial treatment for acute cryptococcal meningitis followed by oral therapy in AIDS and non-AIDS patients. Lack of satisfactory response will allow increase of dose. Both newly diagnosed and relapsed patients are eligible.
Condition | Intervention |
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Meningitis, Cryptococcal HIV Infections |
Drug: Fluconazole |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis |
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:
United States, Illinois | |
Cook County Hosp | |
Chicago, Illinois, United States, 60612 | |
United States, New Jersey | |
Saint Michael's Med Ctr | |
Newark, New Jersey, United States, 07102 | |
United States, New York | |
SUNY / Health Sciences Ctr at Brooklyn | |
Brooklyn, New York, United States, 11203 | |
Cabrini Med Ctr | |
New York, New York, United States, 10003 |
Study ID Numbers: | 012K, 056-164 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002077 |
Health Authority: | United States: Food and Drug Administration |
AIDS-Related Opportunistic Infections Meningitis Injections, Intravenous Cryptococcosis |
Fluconazole Administration, Oral Acquired Immunodeficiency Syndrome |
Fluconazole Opportunistic Infections Meningitis, Fungal Sexually Transmitted Diseases, Viral Clotrimazole Miconazole Acquired Immunodeficiency Syndrome Tioconazole Central Nervous System Diseases 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 Slow Virus Diseases Immune System Diseases Therapeutic Uses Antifungal Agents |
Nervous System Diseases Lentivirus Infections Central Nervous System Fungal Infections Infection Pharmacologic Actions |