Search / Trial NCT00000676

Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)

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

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Trial Information

Current as of June 13, 2024

Completed

Keywords

Mycoses Fluconazole Clotrimazole Antifungal Agents Acquired Immunodeficiency Syndrome Aids Related Complex

Description

Serious fungal infections are significant complicating and life-threatening occurrences in patients with advanced HIV infection. Oropharyngeal candidiasis is found in almost all such patients, and causes pain, difficulty in swallowing, and loss of appetite. Similarly, esophageal candidiasis causes illness in the population. Cryptococcosis, endemic mycoses, and coccidioidomycosis also cause significant illness and death in AIDS patients. Once established, fungal infections in AIDS patients generally require continuous suppressive therapy because attempts at curing these infections are usuall...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Required:
  • Zidovudine (AZT).
  • Antipneumocystis prophylaxis.
  • Allowed:
  • Topical suppressive antifungal agents.
  • Eligibility requirements are:
  • Participation in NIAID ACTG 081.
  • No history of systemic fungal infection, including esophageal or systemic candidiasis, cryptococcosis, histoplasmosis, coccidioidomycosis, blastomycosis, sporotrichosis, or aspergillosis.
  • Willingness to sign an informed consent.
  • Transaminases < 5 x upper limit of normal.
  • Noncompliance will not be a reason for withdrawal of a patient from the study, unless patient refuses further treatment.
  • Allowed:
  • A history of oropharyngeal, vaginal or cutaneous candidiasis.
  • Dermatophyte infections (i.e., tinea pedis) at entry but not active candida infection. Sites of suspected dermatophyte involvement other than the feet should have candida excluded by culture.
  • Prior Medication:
  • Allowed:
  • Topical suppressive antifungal agents.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions or diseases are excluded:
  • History of systemic fungal infection, including esophageal or systemic candidiasis, cryptococcosis, histoplasmosis, coccidioidomycosis, blastomycosis, sporotrichosis, or aspergillosis.
  • Active systemic fungal infection at time of enrollment.
  • Active superficial fungal infection at time of entry. (Such patients may be treated with topical antifungal agents and may be randomized if they are in clinical remission 14 days after completion of such therapy.)
  • Concurrent Medication:
  • Excluded:
  • Amphotericin B.
  • Fluconazole.
  • Itraconazole.
  • SCH 39304.
  • Other systemic antifungals.
  • Patients with the following are excluded:
  • Previous or currently active systemic fungal infection.
  • History of allergy or intolerance to imidazole or azoles.
  • Positive serum cryptococcal antigen titer at any dilution.
  • Requiring multi-agent therapy for tuberculosis or for symptomatic Mycobacterium avium infection.

Attachments

readout_NCT00000676_2024-06-13.pdf

4.5 MB

NCT00000676_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

Palo Alto, California, United States

San Diego, California, United States

San Francisco, California, United States

Miami, Florida, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

New Orleans, Louisiana, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Minneapolis, Minnesota, United States

Saint Louis, Missouri, United States

Buffalo, New York, United States

New York, 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

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Seattle, Washington, United States

Mbeya, , Tanzania

Pittsburgh, Pennsylvania, 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
0
1 stars
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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

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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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