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

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.

Sponsored by:	Pfizer
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002325

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

MedlinePlus related topics:

AIDS Fungal Infections Molds

Drug Information available for:

Fluconazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Efficacy Study

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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed Description:

Patients are randomized to receive either fluconazole or placebo daily.

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

Study ID Numbers:	012R, R-0266
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002325
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

Study placed in the following topic categories:

Fluconazole

Sexually Transmitted Diseases, Viral

Clotrimazole

Miconazole

Acquired Immunodeficiency Syndrome

Tioconazole

AIDS-Related Complex

Immunologic Deficiency Syndromes

Virus Diseases

Mycoses

HIV Infections

Coccidioidomycosis

Sexually Transmitted Diseases

Retroviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents

Communicable Diseases

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Therapeutic Uses

Antifungal Agents

Lentivirus Infections

Infection

Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008