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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002325
• Other study ID #: 012R
• Secondary ID: R-0266
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Patients are randomized to receive either fluconazole or placebo daily.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coccidioidomycosis
• Communicable Diseases
• HIV Infections
• Infection
• Mycoses

Intervention

Drug:
• Fluconazole

Locations

Country	Name	City	State
United States	McDowell Clinic	Phoenix	Arizona
United States	Dr Lawrence Cone	Rancho Mirage	California
United States	Tucson Veterans Administration Med Ctr	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States,