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| Sponsor: | Janssen, LP |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002132 |
Purpose
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: | Endpoint Classification: Safety Study Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis. |
Eligibility| 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:
Contacts and Locations| United States, Arizona | |
| Dr Eskild A Petersen | |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| UCSD Med Ctr | |
| San Diego, California, United States, 92103 | |
| 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 | |
| Erie County Med Ctr | |
| Buffalo, New York, United States, 14215 | |
| Dr Douglas Dieterich | |
| New York, New York, United States, 10016 | |
| 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 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00002132 History of Changes |
| Other Study ID Numbers: | 236A, ITR-USA-12 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Itraconazole Fluconazole Acquired Immunodeficiency Syndrome Candidiasis Immunocompromised Host |
|
HIV Infections Acquired Immunodeficiency Syndrome Candidiasis Esophageal Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Mycoses Gastrointestinal Diseases Digestive System Diseases Fluconazole Itraconazole Hydroxyitraconazole Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |