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

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ClinicalTrials.gov Identifier: NCT00002325
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

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
Mycoses HIV Infections Coccidioidomycosis Drug: Fluconazole

Detailed Description:
Patients are randomized to receive either fluconazole or placebo daily.

Study Type : Interventional  (Clinical Trial)
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

Resource links provided by the National Library of Medicine

Drug Information available for: Fluconazole
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:


  • Systemic antifungal therapy.

Patients with the following prior conditions are excluded:

History of hypersensitivity to azole or imidazole compounds.

Prior Medication:


  • Systemic antifungal agents within 2 weeks prior to study entry.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002325

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

ClinicalTrials.gov Identifier: NCT00002325     History of Changes
Other Study ID Numbers: 012R
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: April 1996

Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
AIDS-Related Complex

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Protozoan Infections
Parasitic Diseases
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors