A Study of Fluconazole in the Prevention of Fungal Infections in HIV-Infected Patients Living in Areas Where Fungal Infections Are Common
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mycoses; HIV Infections; Coccidioidomycosis
Intervention: Fluconazole (Drug)
Phase: N/A
Status: Completed
Sponsored by: Pfizer
Summary
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.
Clinical Details
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
Study design: Treatment, Parallel Assignment, Efficacy Study
Detailed description:
Patients are randomized to receive either fluconazole or placebo daily.
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
McDowell Clinic, Phoenix, Arizona 85006, United States
Tucson Veterans Administration Med Ctr, Tucson, Arizona 85723, United States
Dr Lawrence Cone, Rancho Mirage, California 92270, United States
Additional Information
Last updated: June 23, 2005
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