Clinical Trial: 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: AIDS Clinical Trials Information Service

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 Treatment or Intervention
Mycoses
HIV Infections
Coccidioidomycosis
 Drug: Fluconazole

MedlinePlus related topics:  AIDS;   Fungal Infections

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: 

Patients are randomized to receive either fluconazole or placebo daily.

Eligibility

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

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.

Location Information


Arizona
      McDowell Clinic, Phoenix,  Arizona,  85006,  United States

      Tucson Veterans Administration Med Ctr, Tucson,  Arizona,  85723,  United States

California
      Dr Lawrence Cone, Rancho Mirage,  California,  92270,  United States

More Information

Study ID Numbers:  012R; R-0266
Record last reviewed:  April 1996
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002325
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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