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”

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.

Study Type: Interventional

Study Design: Treatment, Parallel Assignment, Efficacy Study

Patients are randomized to receive either fluconazole or placebo daily.

Intervention(s) in this Clinical Trial

• Drug: Fluconazole

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 13 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002325

Study ID Number: 012R

ClinicalTrials.gov Identifier: NCT00002325

Health Authority: United States: Food and Drug Administration