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| Sponsors and Collaborators: |
Washington University School of Medicine National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000639 |
Purpose
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 |
|
Meningitis, Cryptococcal HIV Infections |
Drug: Itraconazole Drug: Flucytosine Drug: Fluconazole Drug: Amphotericin B |
| MedlinePlus related topics: | AIDS Meningitis |
| Drug Information available for: | Itraconazole Amphotericin B Fluconazole Flucytosine |
| 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.
Eligibility
| 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:
Contacts and Locations![]() |
Show 64 Study Locations |
| Washington University School of Medicine |
| National Institute of Allergy and Infectious Diseases (NIAID) |
| Study Chair: | van der Horst C | |
| Study Chair: | Saag M |
More Information
Click here for more information about Fluconazole 
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Click here for more information about Amphotericin B 
  |
Click here for more information about Itraconazole 
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van der Horst CM, Saag MS, Cloud GA, Hamill RJ, Graybill JR, Sobel JD, Johnson PC, Tuazon CU, Kerkering T, Moskovitz BL, Powderly WG, Dismukes WE. Treatment of cryptococcal meningitis associated with the acquired immunodeficiency syndrome. National Institute of Allergy and Infectious Diseases Mycoses Study Group and AIDS Clinical Trials Group. N Engl J Med. 1997 Jul 3;337(1):15-21.
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Powderly WG. Recent advances in the management of cryptococcal meningitis in patients with AIDS. Clin Infect Dis. 1996 May;22 Suppl 2:S119-23. Review.
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Powderly WG, Tuazon C, Cloud GA, Saag MS, Van Der Horst C. Serum and CSF cryptococcal antigen in management of cryptococcal meningitis in AIDS. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:66 (abstract no 6)
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| Study ID Numbers: | ACTG 159, FDA 235A, MSG Study 17 |
| First Received: | November 2, 1999 |
| Last Updated: | August 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000639 |
| Health Authority: | United States: Federal Government |
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