A Study of Fluconazole in the Prevention of Fungal Infections in HIV-Infected Patients Living in Areas Where Fungal Infections Are Common
NCT00002325
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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.
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.
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Descriptive Information | |||
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Brief Title ICMJE | A Study of Fluconazole in the Prevention of Fungal Infections in HIV-Infected Patients Living in Areas Where Fungal Infections Are Common | ||
Official Title ICMJE | 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 | ||
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. | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Not Applicable | ||
Study Design ICMJE | Intervention Model: Parallel Assignment Primary Purpose: Treatment | ||
Condition ICMJE |
| ||
Intervention ICMJE | Drug: Fluconazole | ||
Study Arms ICMJE | Not Provided | ||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Enrollment ICMJE | Not Provided | ||
Original Enrollment ICMJE | Not Provided | ||
Study Completion Date ICMJE | Not Provided | ||
Primary Completion Date | Not Provided | ||
Eligibility Criteria ICMJE | Inclusion Criteria Patients must have:
Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded:
Concurrent Medication: Excluded:
Patients with the following prior conditions are excluded: History of hypersensitivity to azole or imidazole compounds. Prior Medication: Excluded:
| ||
Sex/Gender ICMJE |
| ||
Ages ICMJE | 13 Years and older (Child, Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00002325 | ||
Other Study ID Numbers ICMJE | 012R R-0266 | ||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Not Provided | ||
Study Sponsor ICMJE | Pfizer | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | NIH AIDS Clinical Trials Information Service | ||
Verification Date | April 1996 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |