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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002325 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

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 Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Mycoses HIV Infections Coccidioidomycosis
Intervention ^ICMJE	Drug: Fluconazole
Study Arms / Comparison Groups
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 ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
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.
Gender	Both
Ages	13 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002325
Responsible Party
Study ID Numbers ^ICMJE	012R, R-0266
Study Sponsor ^ICMJE	Pfizer
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	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