Search / Trial NCT00001542

Fluconazole Prophylaxis of Thrush in AIDS

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · May 21, 2002

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Trial Information

Current as of February 21, 2024

Completed

Keywords

Candidiasis Azole Resistance Candida Albicans Oropharynx

Description

Oropharyngeal candidiasis (OPC) occurs in up to 93% of persons with human immunodeficiency virus (HIV) infection at some time during the course of their illness. OPC usually responds well to initial antifungal therapy, but with increasing immunodeficiency it usually recurs and can become resistant to clinical and microbiologic cure. Therapy usually begins with topical agents, followed by systemic therapy with azole antifungals when those fail. Amphotericin B is also used, but is less well tolerated and usually only effective in parenteral form. Because of its bioavailability and efficacy, f...

Gender

All

Eligibility criteria

  • HIV infection previously documented by ELISA test kit and confirmed by either Western Blot, HIV antigen, HIV culture, or a second antibody test other than ELISA.
  • Age 18 years or older.
  • CD4 count of less than or equal to 150 cells/mm(3).
  • At least one prior episode of health care provider diagnosed oropharyngeal candidiasis in the 6 months preceding enrollment.
  • No allergy or intolerance to azoles.
  • Less than 3 episodes of oropharyngeal candidiasis within the last 3 months.
  • No history of esophageal candidiasis.
  • No presence of systemic fungal infection requiring continuous antifungal therapy.
  • No use of continuous azole treatment (i.e. daily, weekly, every other day, twice weekly fluconazole, itraconazole, ketoconazole or coltrimazole) for the prevention of fungal infections greater than or equal to 1 month within the past 6 months.
  • No severe liver disease (ALT or AST greater than 5 times the upper limit of normal).
  • No history of poorly responsive mucosal infection (i.e., requiring more than 200 mg of fluconazole daily or more than 14 days of therapy).
  • Females may not be pregnant or lactating. Must have a negative pregnancy test within 2 weeks of enrollment.
  • No one unlikely to survive more than 6 months.
  • Must have ability to tolerate oral medications.
  • No presence of active mucosal infection or symptoms of OPC/EC at time of initial assessment. (Note: Can enroll 2 weeks after resolution of the active episode).
  • No patients currently being treated with azole for recent mucosal infection. (Note: These patients can enroll 2 weeks after the completion of azole therapy.)
  • No presence of severe renal insufficiency as indicated by a serum creatinine greater than or equal to 3.0.
  • Women must be taking appropriate birth control measures.

Attachments

readout_NCT00001542_2024-02-21.pdf

4.5 MB

NCT00001542_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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