CClinicalTrials.gg
CompletedNCT00002325Updated Jun 24, 2005

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

An interventional study of Fluconazole in Mycoses, HIV Infections and Coccidioidomycosis, sponsored by Pfizer. Completed at 3 sites in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Pfizer · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Ages
13 Years and older
Sex
All
01

Study 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.

Read the detailed description

Patients are randomized to receive either fluconazole or placebo daily.

02

Conditions studied

  • Mycoses
  • HIV Infections
  • Coccidioidomycosis

Keywords

  • Mycoses
  • Fluconazole
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Coccidioidomycosis
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

Browse Infections studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Intervention model
Parallel assignment

Interventions

  • DrugFluconazole
06

Study locations

3 sites
  • McDowell Clinic
    Phoenix, Arizona 85006, United States
  • Tucson Veterans Administration Med Ctr
    Tucson, Arizona 85723, United States
  • Dr Lawrence Cone
    Rancho Mirage, California 92270, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002325
Lead sponsor
Pfizer
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 1996. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion