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Sponsored by: |
Pfizer |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002282 |
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 |
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Candidiasis, Oral HIV Infections |
Drug: Clotrimazole Drug: 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 |
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).
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 |
Study ID Numbers: | 012M, 056-171 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002282 History of Changes |
Health Authority: | United States: Food and Drug Administration |
AIDS-Related Opportunistic Infections Fluconazole Clotrimazole Acquired Immunodeficiency Syndrome Candidiasis, Oral |
Fluconazole Mouth Diseases Anti-Infective Agents Opportunistic Infections Candidiasis, Oral Sexually Transmitted Diseases, Viral Candidiasis Clotrimazole Miconazole Acquired Immunodeficiency Syndrome |
Immunologic Deficiency Syndromes Virus Diseases Anti-Infective Agents, Local Mycoses HIV Infections Antifungal Agents AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Stomatognathic Diseases Retroviridae Infections |
Mouth Diseases Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Candidiasis, Oral Slow Virus Diseases Candidiasis Clotrimazole Miconazole Infection Mycoses Antifungal Agents Therapeutic Uses |
Retroviridae Infections Fluconazole RNA Virus Infections Immune System Diseases Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Anti-Infective Agents, Local HIV Infections Sexually Transmitted Diseases Lentivirus Infections Stomatognathic Diseases |