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Clinical Trials

MainTitle

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
Sponsor
Pfizer


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002325

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 1996
History of Changes
Purpose

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: 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

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

Eligibility

Ages Eligible for Study: 13 Years and older  
Sexes Eligible for Study: All  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

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

More Information


Responsible Party: Pfizer  
ClinicalTrials.gov Identifier: NCT00002325   History of Changes  
Other Study ID Numbers: 012R  
  R-0266  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Mycoses
Fluconazole
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Coccidioidomycosis

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Mycoses
Coccidioidomycosis
Coccidiosis
Fluconazole

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.