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| Sponsored by: |
Pfizer |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002282 |
Purpose
To compare the efficacy, safety, and tolerance of fluconazole single daily capsule for 14 days versus clotrimazole troche 5 x daily for 14 days in the treatment of oropharyngeal candidiasis in patients with AIDS.
| Condition | Intervention |
|
Candidiasis, Oral HIV Infections |
Drug: Clotrimazole Drug: Fluconazole |
| MedlinePlus related topics: | AIDS Yeast Infections |
| ChemIDplus related topics: | Clotrimazole Miconazole Miconazole nitrate Tioconazole Fluconazole |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Randomized Multicenter Study of the Efficacy, Safety, and Toleration of Fluconazole or Clotrimazole Troches in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome |
Eligibility
| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Concurrent Medication:
Excluded pending results of phase I studies to determine whether interaction between fluconazole and these agents occurs:
Patients with the following are excluded:
Prior Medication:
Excluded within 3 days of study entry:
Patients meeting CDC criteria for diagnosis of AIDS, or having serologic or virologic evidence of HIV infection (but without AIDS-defining opportunistic infections as of yet).
Contacts and Locations| United States, California | |||||
| Davies Med Ctr | |||||
| San Francisco, California, United States, 94114 | |||||
| Summitt Med Ctr / San Francisco Gen Hosp | |||||
| Oakland, California, United States, 94609 | |||||
| Dr Robert Larsen | |||||
| Los Angeles, California, United States, 90033 | |||||
| UCSF Hosp | |||||
| San Francisco, California, United States, 941430654 | |||||
| United States, Connecticut | |||||
| Saint Raphael's Hosp | |||||
| New Haven, Connecticut, United States, 06511 | |||||
| United States, District of Columbia | |||||
| George Washington Univ Med Ctr | |||||
| Washington, District of Columbia, United States, 20037 | |||||
| United States, Maryland | |||||
| Johns Hopkins Hosp | |||||
| Baltimore, Maryland, United States, 21205 | |||||
| United States, Massachusetts | |||||
| Univ Hosp | |||||
| Boston, Massachusetts, United States, 02118 | |||||
| United States, Missouri | |||||
| Washington Univ School of Medicine | |||||
| St. Louis, Missouri, United States, 63108 | |||||
| United States, New Jersey | |||||
| Saint Michael's Med Ctr | |||||
| Newark, New Jersey, United States, 07102 | |||||
| United States, New York | |||||
| Cornell Univ Med Ctr | |||||
| New York, New York, United States, 10021 | |||||
| Cabrini Med Ctr | |||||
| New York, New York, United States, 10003 | |||||
| SUNY / Health Sciences Ctr at Stony Brook | |||||
| Stony Brook, New York, United States, 117948153 | |||||
| United States, Ohio | |||||
| Ohio State Univ Hosp | |||||
| Columbus, Ohio, United States, 43210 | |||||
| United States, Pennsylvania | |||||
| Buckley Braffman Stern Med Associates | |||||
| Philadelphia, Pennsylvania, United States, 19107 | |||||
| United States, Texas | |||||
| Univ TX San Antonio Health Science Ctr | |||||
| San Antonio, Texas, United States, 78284 | |||||
| United States, Virginia | |||||
| Infectious Disease Physicians Inc | |||||
| Annandale, Virginia, United States, 22203 | |||||
| Pfizer |
More Information
| Study ID Numbers: | 012M, 056-171 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002282 |
| Health Authority: | United States: Food and Drug Administration |
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