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Sponsors and Collaborators: |
Washington University School of Medicine National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000639 |
To evaluate the effectiveness and safety of amphotericin B plus flucytosine (5-fluorocytosine) compared to amphotericin B alone for a first episode of acute cryptococcal meningitis in AIDS patients, and to compare the effectiveness and safety of fluconazole versus itraconazole.
At least 10 percent of patients with a low CD4 count and HIV infection will develop meningitis due to Cryptococcus neoformans. More effective treatments than the standard therapy need to be explored.
Condition | Intervention |
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Meningitis, Cryptococcal HIV Infections |
Drug: Itraconazole Drug: Flucytosine Drug: Fluconazole Drug: Amphotericin B |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Safety Study |
Official Title: | A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis |
Estimated Enrollment: | 400 |
At least 10 percent of patients with a low CD4 count and HIV infection will develop meningitis due to Cryptococcus neoformans. More effective treatments than the standard therapy need to be explored.
Patients are selected by a randomization process to take amphotericin B intravenously (in the vein), for 14 days, and either placebo (ineffective substance) or flucytosine for 14 days. Then patients are again selected by a randomization process to take either (1) fluconazole for a total of 8 weeks plus itraconazole placebo; or (2) itraconazole for a total of 8 weeks plus fluconazole placebo.
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:
- Transfusion, at discretion of investigator, to maintain hemoglobin = or > 7 g/dl.
Patients must have:
Prior Medication:
Allowed:
Fluconazole prophylaxis, not exceeding 200 mg/day.
Risk Behavior:
Allowed:
- History of high-risk behavior for HIV infection (bisexual or homosexual men, intravenous drug abusers) and their sexual partners.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded:
Patients may not have:
Study Chair: | van der Horst C | |
Study Chair: | Saag M |
Study ID Numbers: | ACTG 159, FDA 235A, MSG Study 17 |
Study First Received: | November 2, 1999 |
Last Updated: | August 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00000639 |
Health Authority: | United States: Federal Government |
AIDS-Related Opportunistic Infections Meningitis Cryptococcosis Drug Evaluation Drug Therapy, Combination |
Fluconazole Flucytosine Acquired Immunodeficiency Syndrome Amphotericin B Brain Diseases |
Abelcet Opportunistic Infections Sexually Transmitted Diseases, Viral Clotrimazole Miconazole Flucytosine Brain Diseases Itraconazole Hydroxyitraconazole Liposomal amphotericin B Meningitis Mycoses AIDS-Related Opportunistic Infections Meningitis, Cryptococcal |
Retroviridae Infections Fluconazole Amphotericin B Meningitis, Fungal Acquired Immunodeficiency Syndrome Tioconazole Central Nervous System Diseases Immunologic Deficiency Syndromes Virus Diseases Central Nervous System Infections HIV Infections Sexually Transmitted Diseases Cryptococcosis |
Antimetabolites Anti-Infective Agents RNA Virus Infections Antiprotozoal Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action 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 |