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
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Adult Trials: 18+ Years
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 | |||
|---|---|---|---|
| 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 | |||