NCT00002325

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 1996

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

MycosesHIV InfectionsCoccidioidomycosis

Keywords

MycosesFluconazoleAcquired Immunodeficiency SyndromeAIDS-Related ComplexCoccidioidomycosis

Interventions

FluconazoleDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

McDowell Clinic

Phoenix, Arizona, 85006, United States

Location

Tucson Veterans Administration Med Ctr

Tucson, Arizona, 85723, United States

Location

Dr Lawrence Cone

Rancho Mirage, California, 92270, United States

Location

MeSH Terms

Conditions

MycosesHIV InfectionsCoccidioidomycosisAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Fluconazole

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1996-04

Locations

US(3)