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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002304 |
Purpose
To compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the treatment of candidal esophagitis in immunocompromised patients.
| Condition | Intervention |
|---|---|
|
Candidiasis, Esophageal HIV Infections |
Drug: Ketoconazole Drug: Fluconazole |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Randomized Comparative Multicenter Trial of Fluconazole and Ketoconazole in the Treatment of Esophageal Candidiasis in Immunocompromised Patients |
Eligibility| Ages Eligible for Study: | 13 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Patients must meet the CDC criteria for the diagnosis of AIDS or be otherwise immunocompromised (e.g., malignancy, renal transplant) and have a diagnosis of oral candidiasis and/or esophageal symptoms of dysphagia and/or odynophagia.
Illicit or illegal drug use.
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Good Samaritan Med Ctr | |
| Phoenix, Arizona, United States, 85006 | |
| United States, Arkansas | |
| Arkansas Children's Hosp | |
| Little Rock, Arkansas, United States, 72202 | |
| United States, California | |
| UCSF Hosp | |
| San Francisco, California, United States, 941430654 | |
| ViRx Inc | |
| San Francisco, California, United States, 94103 | |
| Eisenhower Med Ctr | |
| Rancho Mirage, California, United States, 92270 | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| United States, District of Columbia | |
| George Washington Univ Med Ctr | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Med Ctr Clinic | |
| Pensacola, Florida, United States, 325241151 | |
| Regional Oncology Ctr | |
| Daytona Beach, Florida, United States, 32015 | |
| St Petersburg Med Clinics | |
| St. Petersburg, Florida, United States, 33705 | |
| Ctr for Special Immunology | |
| Fort Lauderdale, Florida, United States, 33308 | |
| Mem Hosp Hollywood | |
| Hollywood, Florida, United States, 33021 | |
| United States, Georgia | |
| DeKalb Gen Hosp | |
| Decatur, Georgia, United States, 30033 | |
| Dr Winkler Weinberg | |
| Roswell, Georgia, United States, 30076 | |
| Atlanta Hosp | |
| Riverdale, Georgia, United States, 30274 | |
| Clayton Gen Hosp | |
| Riverdale, Georgia, United States, 30274 | |
| Georgia Baptist Med Ctr | |
| Atlanta, Georgia, United States, 30338 | |
| Gwinnett Med Ctr | |
| Lawrenceville, Georgia, United States, 30245 | |
| United States, Massachusetts | |
| Baystate Med Ctr of Springfield | |
| Springfield, Massachusetts, United States, 01199 | |
| Univ Hosp | |
| Boston, Massachusetts, United States, 02118 | |
| United States, Michigan | |
| Butterworth Hosp | |
| Grand Rapids, Michigan, United States, 49503 | |
| Holland Community Hosp | |
| Holland, Michigan, United States, 49423 | |
| Harper Hosp | |
| Detroit, Michigan, United States, 48201 | |
| Leila Hosp and Health Care Ctr | |
| Battle Creek, Michigan, United States, 49016 | |
| Munson Med Ctr | |
| Traverse City, Michigan, United States, 49684 | |
| United States, Nevada | |
| Dr Eugene Speck | |
| Las Vegas, Nevada, United States, 89109 | |
| United States, New Mexico | |
| Univ of New Mexico School of Medicine | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| Cornell Univ Med Ctr | |
| New York, New York, United States, 10021 | |
| Roswell Park Memorial Institute | |
| Buffalo, New York, United States, 14263 | |
| SUNY / Health Sciences Ctr at Brooklyn | |
| Brooklyn, New York, United States, 11203 | |
| United States, North Carolina | |
| Bowman Gray School of Medicine / North Carolina Baptist Hosp | |
| Winston Salem, North Carolina, United States, 27103 | |
| United States, Pennsylvania | |
| Buckley Braffman Stern Med Associates | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, South Carolina | |
| Wilson Brailsford Clinic | |
| Spartanburg, South Carolina, United States, 29304 | |
| United States, Tennessee | |
| Baroness Erlanger Hosp | |
| Chattanooga, Tennessee, United States, 37403 | |
| Univ of Tennessee | |
| Memphis, Tennessee, United States, 38163 | |
| United States, Texas | |
| Audie L Murphy Veterans Administration Hosp | |
| San Antonio, Texas, United States, 78284 | |
| Univ TX San Antonio Health Science Ctr | |
| San Antonio, Texas, United States, 78284 | |
| Univ TX Galveston Med Branch | |
| Galveston, Texas, United States, 77550 | |
| United States, Virginia | |
| Infectious Disease Physicians Inc | |
| Annandale, Virginia, United States, 22203 | |
| McGuire Virginia Med Ctr | |
| Richmond, Virginia, United States, 23249 | |
| United States, Washington | |
| Virginia Mason Med Ctr | |
| Seattle, Washington, United States, 98101 | |
| Canada, Ontario | |
| Henderson Gen Hosp | |
| Hamilton, Ontario, Canada | |
More Information
| Study ID Numbers: | 012B, 056-150 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002304 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
AIDS-Related Opportunistic Infections Immune Tolerance Ketoconazole Esophagitis |
Fluconazole Acquired Immunodeficiency Syndrome Candidiasis, Oral |
|
Fluconazole Anti-Infective Agents Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Candidiasis Gastrointestinal Diseases Acquired Immunodeficiency Syndrome Ketoconazole Infection |
Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Mycoses Digestive System Diseases HIV Infections Therapeutic Uses Antifungal Agents Sexually Transmitted Diseases Lentivirus Infections Esophageal Diseases Retroviridae Infections |