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

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.

Completed

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Key information

Conditions

Mycoses AIDS-Related Complex Acquired Immunodeficiency Syndrome Bacterial Infections and Mycoses Blood-Borne Infections Coccidioidomycosis Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McDowell Clinic, Phoenix, Arizona, United States

About this study

Patients are randomized to receive either fluconazole or placebo daily.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluconazole

Drug

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Double-Blind, Placebo-Controlled Study of Fluconazole in the Prevention of Active Coccidioidomycosis and Other Systemic Fungal Infections in HIV-Infected Patients Living in the Coccidioidal Endemic Area

Important dates

First posted: Aug 31, 2001
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed