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

Brief Title

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

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

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

Interventional




Condition

Mycoses

Intervention

Fluconazole


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug





Eligibility 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.
      

Gender

All

Ages

13 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00002325

Organization ID

012R

Secondary IDs

R-0266


Study Sponsor

Pfizer


Study Sponsor

, , 


Verification Date

April 1996