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Trial record 1 of 1 for:    NCT00002325
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002325
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

Tracking Information
First Submitted Date  ICMJE November 2, 1999
First Posted Date  ICMJE August 31, 2001
Last Update Posted Date June 24, 2005
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Fluconazole in the Prevention of Fungal Infections in HIV-Infected Patients Living in Areas Where Fungal Infections Are Common
Official Title  ICMJE 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
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.
Detailed Description Patients are randomized to receive either fluconazole or placebo daily.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Condition  ICMJE
  • Mycoses
  • HIV Infections
  • Coccidioidomycosis
Intervention  ICMJE Drug: Fluconazole
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00002325
Other Study ID Numbers  ICMJE 012R
R-0266
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account NIH AIDS Clinical Trials Information Service
Verification Date April 1996

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP