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

Pfizer

Status: Completed

Conditions: Coccidioidomycosis; Mycoses; HIV Infections

Treatments: Drug: Fluconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002325

012R

R-0266

Details and patient eligibility

About

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.

Full description

Patients are randomized to receive either fluconazole or placebo daily.

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.