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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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Fluconazole

About this trial

This is an interventional treatment trial for Mycoses focused on measuring Mycoses, Fluconazole, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Coccidioidomycosis

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

McDowell Clinic
Tucson Veterans Administration Med Ctr
Dr Lawrence Cone

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002325

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00002325

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

April 1996

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

5. Study Description

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.

Detailed Description

Patients are randomized to receive either fluconazole or placebo daily.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mycoses, HIV Infections, Coccidioidomycosis

Keywords

Mycoses, Fluconazole, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Coccidioidomycosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Fluconazole

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Facility Information:

Facility Name

McDowell Clinic

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85006

Country

United States

Facility Name

Tucson Veterans Administration Med Ctr

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85723

Country

United States

Facility Name

Dr Lawrence Cone

City

Rancho Mirage

State/Province

California

ZIP/Postal Code

92270

Country

United States

Mycoses, HIV Infections, Coccidioidomycosis

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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