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| Sponsor: | 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 |
| 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 | |
More Information
| 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 |
|
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 |