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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

NCT ID: NCT00002325

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Patients are randomized to receive either fluconazole or placebo daily.

Conditions

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Mycoses HIV Infections Coccidioidomycosis

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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Fluconazole

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Locations

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McDowell Clinic

Phoenix, Arizona, United States

Site Status

Tucson Veterans Administration Med Ctr

Tucson, Arizona, United States

Site Status

Dr Lawrence Cone

Rancho Mirage, California, United States

Site Status

Countries

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United States

Other Identifiers

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R-0266

Identifier Type: -

Identifier Source: secondary_id

012R

Identifier Type: -

Identifier Source: org_study_id