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Sponsored by: |
Pfizer |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002113 |
To evaluate and estimate the safety and efficacy of the combination of fluconazole and flucytosine as treatment for acute cryptococcal meningitis in patients with AIDS. Fluconazole and flucytosine have different mechanisms of action. Since fluconazole has not been associated with hematologic suppression and does not produce renal impairment that can result in higher serum flucytosine levels, this combination may be better tolerated than is amphotericin B plus flucytosine.
Condition | Intervention |
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Meningitis, Cryptococcal HIV Infections |
Drug: Flucytosine Drug: Fluconazole |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Safety Study |
Official Title: | A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis. |
Estimated Enrollment: | 64 |
Fluconazole and flucytosine have different mechanisms of action. Since fluconazole has not been associated with hematologic suppression and does not produce renal impairment that can result in higher serum flucytosine levels, this combination may be better tolerated than is amphotericin B plus flucytosine.
Patients in each cohort receive a lower dose of fluconazole alone or in combination with flucytosine, or a higher dose of fluconazole alone. Doses in subsequent cohorts are escalated if safety data in the previous cohort is satisfactory. Patients are evaluated weekly for the first 4 weeks and every 2 weeks thereafter. Therapy continues until 8 weeks after the CSF becomes culture negative, up to a maximum of 26 weeks.
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:
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
History of allergy to or intolerance of imidazoles, azoles, or flucytosine.
Prior Medication:
Excluded:
United States, California | |
UCI Med Ctr | |
Orange, California, United States, 92668 | |
Los Angeles County - USC Med Ctr | |
Los Angeles, California, United States, 90033 | |
UCSD Med Ctr - Owen Clinic | |
San Diego, California, United States, 921038681 |
Study ID Numbers: | 213A, R-0202 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002113 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Meningitis Cryptococcosis Drug Therapy, Combination |
Fluconazole Flucytosine Acquired Immunodeficiency Syndrome |
Antimetabolites Fluconazole Anti-Infective Agents Sexually Transmitted Diseases, Viral Meningitis, Fungal Acquired Immunodeficiency Syndrome Central Nervous System Diseases Flucytosine Immunologic Deficiency Syndromes Meningitis |
Virus Diseases Mycoses Central Nervous System Infections HIV Infections Antifungal Agents Sexually Transmitted Diseases Meningitis, Cryptococcal Central Nervous System Fungal Infections Cryptococcosis Retroviridae Infections |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Flucytosine Infection Meningitis Mycoses Therapeutic Uses Antifungal Agents 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 |