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Sponsored by: |
Janssen, LP |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002132 |
To evaluate the safety and efficacy of itraconazole oral solution versus fluconazole tablets for the treatment of esophageal candidiasis in immunocompromised patients.
Condition | Intervention |
---|---|
Candidiasis, Esophageal HIV Infections |
Drug: Itraconazole Drug: Fluconazole |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Safety Study |
Official Title: | Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis. |
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
United States, Arizona | |
Dr Eskild A Petersen | |
Tucson, Arizona, United States, 85724 | |
United States, California | |
UCSD Med Ctr | |
San Diego, California, United States, 92103 | |
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, Georgia | |
Emory Univ School of Medicine | |
Atlanta, Georgia, United States, 30303 | |
United States, Illinois | |
Rush Presbyterian - Saint Luke's Med Ctr | |
Chicago, Illinois, United States, 60612 | |
United States, Maryland | |
Johns Hopkins Univ School of Medicine | |
Baltimore, Maryland, United States, 21205 | |
United States, Michigan | |
Wayne State Univ / Harper Hosp | |
Detroit, Michigan, United States, 48201 | |
United States, Missouri | |
Univ of Missouri at Kansas City School of Medicine | |
Kansas City, Missouri, United States, 64108 | |
Infectious Diseases Association / Research Med Ctr | |
Kansas City, Missouri, United States, 64132 | |
United States, New York | |
Montefiore Med Ctr | |
Bronx, New York, United States, 10467 | |
Dr Douglas Dieterich | |
New York, New York, United States, 10016 | |
Erie County Med Ctr | |
Buffalo, New York, United States, 14215 | |
United States, North Carolina | |
Univ of North Carolina | |
Chapel Hill, North Carolina, United States, 27599 | |
Bowman Gray School of Medicine | |
Winston Salem, North Carolina, United States, 27157 | |
United States, Ohio | |
Univ Hosps of Cleveland | |
Cleveland, Ohio, United States, 44106 | |
United States, Texas | |
Austin Infectious Disease Consultants | |
Austin, Texas, United States, 78705 | |
Houston Veterans Administration Med Ctr | |
Houston, Texas, United States, 77030 |
Study ID Numbers: | 236A, ITR-USA-12 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002132 |
Health Authority: | United States: Food and Drug Administration |
Itraconazole Fluconazole Acquired Immunodeficiency Syndrome Candidiasis Immunocompromised Host |
Fluconazole Sexually Transmitted Diseases, Viral Candidiasis Esophageal disorder Clotrimazole Gastrointestinal Diseases Miconazole Acquired Immunodeficiency Syndrome Tioconazole Hydroxyitraconazole |
Itraconazole Immunologic Deficiency Syndromes Virus Diseases Mycoses Digestive System Diseases HIV Infections Sexually Transmitted Diseases Esophageal Diseases Retroviridae Infections |
Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents RNA Virus Infections Slow Virus Diseases Immune System Diseases |
Therapeutic Uses Antifungal Agents Lentivirus Infections Infection Pharmacologic Actions |