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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 History of Changes |
Health Authority: | United States: Food and Drug Administration |
AIDS-Related Opportunistic Infections Meningitis Injections, Intravenous Cryptococcosis |
Fluconazole Administration, Oral Acquired Immunodeficiency Syndrome |
Fluconazole Anti-Infective Agents Opportunistic Infections Meningitis, Fungal Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Central Nervous System Diseases Immunologic Deficiency Syndromes Meningitis Virus Diseases |
Mycoses Central Nervous System Infections HIV Infections Antifungal Agents AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Meningitis, Cryptococcal Central Nervous System Fungal Infections Cryptococcosis Retroviridae Infections |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Infection Meningitis Mycoses Antifungal Agents Therapeutic Uses Meningitis, Cryptococcal Central Nervous System Fungal Infections Retroviridae Infections Fluconazole RNA Virus Infections |
Meningitis, Fungal Immune System Diseases Acquired Immunodeficiency Syndrome Nervous System Diseases Central Nervous System Diseases Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Central Nervous System Infections HIV Infections Sexually Transmitted Diseases Lentivirus Infections Cryptococcosis |