Search / Trial NCT00000951

A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients With Recurrent Thrush

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of June 14, 2024

Completed

Keywords

Aids Related Opportunistic Infections Fluconazole Antifungal Agents Candidiasis, Oral Drug Administration Schedule Pharyngeal Diseases

Description

This study will evaluate two different management strategies for patients with advanced HIV infection who are at risk for recurrent and fluconazole-refractory oropharyngeal candidiasis. The treatment duration will be at least 24 months in order to evaluate the long-term effects of the treatment strategies on the development of fluconazole-refractory thrush. In addition to investigating antifungal treatment as it relates to fluconazole-refractory infections, the study will evaluate host factors and organism-related factors in order to increase our understanding of the pathogenesis of orophar...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • You may be eligible for this study if you:
  • Are HIV-positive.
  • Have a CD4+ cell count less than 150 cells/mm3.
  • Had at least one episode of thrush in the 24 months before study entry.
  • Have a life expectancy of at least 12 months.
  • Weigh at least 88 pounds.
  • Are 13 years of age or older (consent of parent or guardian required if under 18).
  • Agree to practice abstinence or use effective methods of birth control during the study.
  • Exclusion Criteria
  • You will not be eligible for this study if you:
  • Have an allergy to azoles.
  • Have had 3 episodes or more of thrush within 12 weeks of study entry.
  • Have a history of esophageal candidiasis.
  • Have a history of fluconazole-resistant infection.
  • Have an active opportunistic infection requiring treatment within 14 days before study entry.
  • Have a fungal infection requiring certain medications.
  • Have a severe liver disease (e.g., cirrhosis).
  • Are unable to tolerate oral medications.
  • Take certain medications.
  • Are pregnant or breast-feeding.

Attachments

readout_NCT00000951_2024-06-14.pdf

4.5 MB

NCT00000951_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

Los Angeles, California, United States

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

Saint Louis, Missouri, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Columbus, Ohio, United States

West Columbia, South Carolina, United States

San Francisco, California, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Seattle, Washington, United States

San Diego, California, United States

Chicago, Illinois, United States

Bronx, New York, United States

New York, New York, United States

Rochester, New York, United States

Chapel Hill, North Carolina, United States

Durham, North Carolina, United States

Cleveland, Ohio, United States

Washington, District Of Columbia, United States

Miami, Florida, United States

Honolulu, Hawaii, United States

Honolulu, Hawaii, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Baltimore, Maryland, United States

Omaha, Nebraska, United States

Buffalo, New York, United States

New York, New York, United States

Cincinnati, Ohio, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Philadelphia, Pennsylvania, United States

Galveston, Texas, United States

San Juan, , Puerto Rico

Los Angeles, California, United States

Minneapolis, Minnesota, United States

New York, New York, United States

Denver, Colorado, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Knoxville, Tennessee, United States

Iowa City, Iowa, United States

Minneapolis, Minnesota, United States

Saint Paul, Minnesota, United States

Atlanta, Georgia, United States

Atlanta, Georgia, United States

Indianapolis, Indiana, United States

New York, New York, United States

Philadelphia, Pennsylvania, United States

Rochester, New York, United States

Washington, District Of Columbia, 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

5 stars
41
4 stars
6
3 stars
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2 stars
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1 stars
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Leslie Alexander
20 September 2023

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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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