A Study of Fluconazole in the Prevention of Fungal Infections in HIV-Infected Patients Living in Areas Where Fungal Infections Are Common

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00002325

Collaborator

(none)

Locations

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Mycoses HIV Infections Coccidioidomycosis	Drug: Fluconazole	N/A

Detailed Description

Patients are randomized to receive either fluconazole or placebo daily.

Study Design

Study Type:

Interventional

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	McDowell Clinic	Phoenix	Arizona	United States	85006
2	Tucson Veterans Administration Med Ctr	Tucson	Arizona	United States	85723
3	Dr Lawrence Cone	Rancho Mirage	California	United States	92270