A Study of Fluconazole in the Prevention of Fungal Infections in HIV-Infected Patients Living in Areas Where Fungal Infections Are Common
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 1996
History of Changes
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.
Drug : Fluconazole
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Patients are randomized to receive either fluconazole or placebo daily.Eligibility
|Ages Eligible for Study:||13 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- Unable to take oral medication.
- Positive serum cryptococcal antigen.
- Systemic antifungal therapy.
- Systemic antifungal agents within 2 weeks prior to study entry.
Patients with the following symptoms or conditions are excluded:
Patients with the following prior conditions are excluded:
History of hypersensitivity to azole or imidazole compounds.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002325
Locations Show More
|United States, Arizona|
|Phoenix, Arizona, United States, 85006|
|Tucson Veterans Administration Med Ctr|
|Tucson, Arizona, United States, 85723|
|United States, California|
|Dr Lawrence Cone|
|Rancho Mirage, California, United States, 92270|
Sponsors and CollaboratorsPfizer
|ClinicalTrials.gov Identifier:||NCT00002325 History of Changes|
|Other Study ID Numbers:||012R|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Mycoses
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on September 25, 2018
This information is provided by ClinicalTrials.gov.