A Study of Fluconazole in the Prevention of Fungal Infections in HIV-Infected Patients Living in Areas Where Fungal Infections Are Common
This study has been completed.
Sponsor:
Pfizer
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002325
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1996
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Purpose
To compare the efficacy of fluconazole versus placebo in preventing the development of active coccidioidomycosis and other systemic fungal infections among HIV-infected patients with CD4 lymphocyte counts < 250 cells/mm3 who are living in the coccidioidal endemic area.
Condition | Intervention |
---|---|
Mycoses HIV Infections Coccidioidomycosis |
Drug: Fluconazole |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
Official Title: | A Double-Blind, Placebo-Controlled Study of Fluconazole in the Prevention of Active Coccidioidomycosis and Other Systemic Fungal Infections in HIV-Infected Patients Living in the Coccidioidal Endemic Area |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Fluconazole
U.S. FDA Resources
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Eligibility
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
Patients must have:
- Documented HIV infection.
- CD4 count < 250 cells/mm3.
- No active coccidioidomycosis or other fungal disease requiring systemic antifungal therapy.
- Residence in area considered to be endemic for Coccidioides immitis.
- Consent of parent or guardian if under legal age of consent.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Unable to take oral medication.
- Positive serum cryptococcal antigen.
Concurrent Medication:
Excluded:
- Systemic antifungal therapy.
Patients with the following prior conditions are excluded:
History of hypersensitivity to azole or imidazole compounds.
Prior Medication:
Excluded:
- Systemic antifungal agents within 2 weeks prior to study entry.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002325
Locations
United States, Arizona | |
McDowell Clinic | |
Phoenix, Arizona, United States, 85006 | |
Tucson Veterans Administration Med Ctr | |
Tucson, Arizona, United States, 85723 | |
United States, California | |
Dr Lawrence Cone | |
Rancho Mirage, California, United States, 92270 |
Sponsors and Collaborators
Pfizer
More Information
No publications provided
Keywords provided by NIH AIDS Clinical Trials Information Service:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 10, 2013
No publications provided
ClinicalTrials.gov Identifier: | NCT00002325 History of Changes |
Other Study ID Numbers: | 012R, R-0266 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Mycoses Fluconazole Acquired Immunodeficiency Syndrome AIDS-Related Complex Coccidioidomycosis |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Coccidioidomycosis Coccidiosis Mycoses Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Slow Virus Diseases Protozoan Infections Parasitic Diseases Fluconazole Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on March 10, 2013