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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00002325
Other study ID # 012R
Secondary ID R-0266
Status Completed
Phase N/A
First received November 2, 1999
Last updated June 23, 2005

Study information

Verified date April 1996
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

Patients are randomized to receive either fluconazole or placebo daily.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment


Intervention

Drug:
Fluconazole


Locations

Country Name City State
United States McDowell Clinic Phoenix Arizona
United States Dr Lawrence Cone Rancho Mirage California
United States Tucson Veterans Administration Med Ctr Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

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