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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



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

For Condition: Mycoses,HIV Infections,Coccidioidomycosis
Status: Completed
Sponsor(s): Pfizer ,
Synopsis: 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.
Details: Patients are randomized to receive either fluconazole or placebo daily.
Eligibility:
Study Type:
  Interventional, Treatment, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

McDowell Clinic
Phoenix,  Arizona,  85006
United States
 

Dr Lawrence Cone
Rancho Mirage,  California,  92270
United States
 

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


Additional Information:
Study ID Numbers:
  012R;  R-0266
Study Start Date: 
Record last reviewed: April 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002325

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