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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 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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002325
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coccidioidomycosis, HIV Infections, Mycoses

Keywords

Mycoses, Fluconazole, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Coccidioidomycosis

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.

Interventions

DRUGFluconazole

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Intervention model
PARALLEL
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026