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

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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.

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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