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.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS Fungal Infections Molds

Drug Information available for: Fluconazole

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	012R, R-0266
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002325 History of Changes
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
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Immunologic Deficiency Syndromes
Virus Diseases

Mycoses
HIV Infections
Antifungal Agents
Coccidioidomycosis
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:

Fluconazole
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Pharmacologic Actions

Immunologic Deficiency Syndromes
Virus Diseases
Mycoses
HIV Infections
Therapeutic Uses
Antifungal Agents
Coccidioidomycosis
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on September 01, 2009