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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000708 |
To compare the safety and effectiveness of fluconazole (FCZ) and amphotericin B (AMB), alone or in combination with flucytosine (FLC), as treatment for acute cryptococcal meningitis in patients who have not been treated previously or who have relapsed after a previous successful treatment.
Cryptococcal meningitis is an important cause of disease and death among patients with AIDS. Usually AMB is given either alone or with FLC to patients with this infection, but these treatments are not always effective and both have toxic effects. Animal studies and preliminary studies in humans show that FCZ is active in cryptococcal meningitis and suggest that it may be less toxic than either AMB or FLC.
Condition | Intervention |
Meningitis, Cryptococcal HIV Infections |
Drug: Flucytosine Drug: Fluconazole Drug: Amphotericin B |
MedlinePlus related topics: | AIDS Meningitis |
Drug Information available for: | Amphotericin B Fluconazole Flucytosine |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment |
Official Title: | Multi-Center Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis |
Estimated Enrollment: | 120 |
Cryptococcal meningitis is an important cause of disease and death among patients with AIDS. Usually AMB is given either alone or with FLC to patients with this infection, but these treatments are not always effective and both have toxic effects. Animal studies and preliminary studies in humans show that FCZ is active in cryptococcal meningitis and suggest that it may be less toxic than either AMB or FLC.
Patients accepted into the study are randomly assigned to FCZ or AMB. Patients assigned to FCZ take FCZ by mouth daily for 10 weeks. Patients assigned to AMB are given intravenous injections of AMB daily for 6-10 weeks. Non-AIDS patients assigned to AMB also take FLC by mouth daily. The use of FLC in patients with AIDS is decided on an individual basis. Patients with AIDS who respond satisfactorily to FCZ receive maintenance therapy to prevent relapse for an additional 12 months. Patients with AIDS who respond to AMB may qualify for another Pfizer Central Research protocol. Patients without AIDS who respond to therapy are observed for 6 months for relapse. During therapy, samples of blood and cerebrospinal fluid (by lumbar puncture) are taken periodically in order to evaluate the effectiveness of the drug treatments and to identify possible toxic effects.
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:
- Radiation therapy for mucocutaneous Kaposi's sarcoma.
Patients must have:
Prior Medication:
Allowed within 4 weeks of study entry:
- Successful prior therapy for cryptococcosis, but no more than 1 mg/kg/week amphotericin B.
Allowed:
Exclusion Criteria
Co-existing Condition:
Excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Lymphocyte replacement.
Prior Medication:
Excluded within 4 weeks of study entry:
Patients unlikely to survive more than 2 weeks.
United States, Florida | |||||
Univ of Miami School of Medicine | |||||
Miami, Florida, United States, 331361013 | |||||
United States, Louisiana | |||||
Tulane Univ School of Medicine | |||||
New Orleans, Louisiana, United States, 70112 | |||||
United States, New York | |||||
Mem Sloan - Kettering Cancer Ctr | |||||
New York, New York, United States, 10021 | |||||
Bronx Municipal Hosp Ctr/Jacobi Med Ctr | |||||
Bronx, New York, United States, 10461 | |||||
United States, North Carolina | |||||
Univ of North Carolina | |||||
Chapel Hill, North Carolina, United States, 275997215 | |||||
United States, South Carolina | |||||
Julio Arroyo | |||||
West Columbia, South Carolina, United States, 29169 |
Study Chair: | Armstrong D |
Click here for more information about Fluconazole 
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Click here for more information about Amphotericin B 
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Study ID Numbers: | ACTG 059, Protocol 159, Project 056, Investigator 556 |
First Received: | November 2, 1999 |
Last Updated: | July 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00000708 |
Health Authority: | United States: Federal Government |
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