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Sponsors and Collaborators: |
Pfizer National Institute of Allergy and Infectious Diseases (NIAID) |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000627 |
To evaluate the use of fluconazole as (1) induction therapy in histoplasmosis, (2) maintenance therapy to prevent relapse of histoplasmosis.
Histoplasmosis is a serious opportunistic infection in patients with AIDS. Fluconazole is a triazole antifungal agent that has been used successfully in the treatment of experimental histoplasmosis in animals, but has not been completely evaluated in patients for this use. It has been approved by the Food and Drug Administration for certain other fungal infections. Nevertheless, physicians are prescribing it to their patients with histoplasmosis. This is a pilot study to examine the role of fluconazole for treating histoplasmosis in AIDS patients.
Condition | Intervention |
HIV Infections Histoplasmosis |
Drug: Fluconazole |
MedlinePlus related topics: | AIDS |
Drug Information available for: | Fluconazole |
Study Type: | Interventional |
Study Design: | Treatment, Efficacy Study |
Official Title: | Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome |
Estimated Enrollment: | 90 |
Histoplasmosis is a serious opportunistic infection in patients with AIDS. Fluconazole is a triazole antifungal agent that has been used successfully in the treatment of experimental histoplasmosis in animals, but has not been completely evaluated in patients for this use. It has been approved by the Food and Drug Administration for certain other fungal infections. Nevertheless, physicians are prescribing it to their patients with histoplasmosis. This is a pilot study to examine the role of fluconazole for treating histoplasmosis in AIDS patients.
At least 40 patients with AIDS and an initial episode of disseminated histoplasmosis are selected for the study. Patients receive fluconazole for a total of 12 weeks. Patients who are unable to take the drug orally may receive it intravenously until oral administration is possible. Patients are evaluated at weeks 0, 1, 2, 4, 8, and 12. Patients who are doing well without evidence of clinical failure or dose-limiting toxicity are permitted to continue maintenance therapy to prevent relapse at a reduced dose for an additional 12 months; those who relapse on the reduced dose are permitted to receive re-induction with a higher dose.
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 the following:
Allowed:
Specific criteria defining life-threatening histoplasmosis include:
Prior Medication:
Allowed:
Risk Behavior:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded:
Risk Behavior:
Excluded:
Patients may not have the following prior conditions:
United States, Alabama | |||||
Univ of Alabama at Birmingham | |||||
Birmingham, Alabama, United States, 35294 | |||||
United States, California | |||||
San Francisco Veterans Administration Med Ctr | |||||
San Francisco, California, United States, 94121 | |||||
Univ of Southern California / LA County USC Med Ctr | |||||
Los Angeles, California, United States, 900331079 | |||||
United States, Indiana | |||||
Indiana Univ Hosp | |||||
Indianapolis, Indiana, United States, 462025250 | |||||
Methodist Hosp of Indiana / Life Care Clinic | |||||
Indianapolis, Indiana, United States, 46202 | |||||
United States, Massachusetts | |||||
Baystate Med Ctr of Springfield | |||||
Springfield, Massachusetts, United States, 01199 | |||||
Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial | |||||
Worcester, Massachusetts, United States, 01605 | |||||
United States, Missouri | |||||
St Louis Regional Hosp / St Louis Regional Med Ctr | |||||
St Louis, Missouri, United States, 63112 | |||||
Univ of Missouri at Kansas City School of Medicine | |||||
Kansas City, Missouri, United States, 641082792 | |||||
Infectious Diseases Association / Research Med Ctr | |||||
Kansas City, Missouri, United States, 64132 | |||||
United States, New York | |||||
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp | |||||
Bronx, New York, United States, 10461 | |||||
Montefiore Family Health Ctr / Bronx Municipal Hosp | |||||
Bronx, New York, United States, 10461 | |||||
Samaritan Village Inc / Bronx Municipal Hosp | |||||
Bronx, New York, United States, 10461 | |||||
Mount Sinai Med Ctr | |||||
New York, New York, United States, 10029 | |||||
Cornell Univ Med Ctr | |||||
New York, New York, United States, 10021 | |||||
Saint Luke's - Roosevelt Hosp Ctr | |||||
New York, New York, United States, 10025 | |||||
Montefiore Med Ctr / Bronx Municipal Hosp | |||||
Bronx, New York, United States, 10467 | |||||
Beth Israel Med Ctr | |||||
New York, New York, United States, 10003 | |||||
North Central Bronx Hosp / Bronx Municipal Hosp | |||||
Bronx, New York, United States, 10467 | |||||
United States, Ohio | |||||
Ohio State Univ Hosp Clinic | |||||
Columbus, Ohio, United States, 432101228 | |||||
United States, South Carolina | |||||
Julio Arroyo | |||||
West Columbia, South Carolina, United States, 29169 | |||||
United States, Texas | |||||
Univ TX Health Science Ctr | |||||
Houston, Texas, United States, 77030 | |||||
Houston Veterans Administration Med Ctr | |||||
Houston, Texas, United States, 77030 |
Study Chair: | Wheat LJ |
Click here for more information about Fluconazole 
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Wheat J, Vanden Bossche H, Marichal P. Mechanism for resistance of Histoplasma capsulatum to fluconazole. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:157
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Wheat J, MaWhinney S, Hafner R, McKinsey D, Chen D, Korzun A, Shakan KJ, Johnson P, Hamill R, Bamberger D, Pappas P, Stansell J, Koletar S, Squires K, Larsen RA, Cheung T, Hyslop N, Lai KK, Schneider D, Kauffman C, Saag M, Dismukes W, Powderly W. Treatment of histoplasmosis with fluconazole in patients with acquired immunodeficiency syndrome. National Institute of Allergy and Infectious Diseases Acquired Immunodeficiency Syndrome Clinical Trials Group and Mycoses Study Group. Am J Med. 1997 Sep;103(3):223-32.
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Study ID Numbers: | ACTG 174, R-0245 |
First Received: | November 2, 1999 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00000627 |
Health Authority: | Unspecified |
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