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| Sponsored by: |
Janssen, LP |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002133 |
Purpose
To assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients with oropharyngeal candidiasis that is refractory to fluconazole.
| Condition | Intervention |
|
Candidiasis, Oral HIV Infections |
Drug: Itraconazole |
| MedlinePlus related topics: | AIDS Yeast Infections |
| Drug Information available for: | Itraconazole Fluconazole |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Safety Study |
| Official Title: | An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects. |
Patients receive itraconazole oral solution twice daily. Per 08/15/94 amendment, patients with complete resolution of oropharyngeal candidiasis lesions upon completion of treatment are eligible for maintenance treatment on protocol FDA 236C. Patients who decline maintenance are followed for 6 weeks. Patients who relapse during follow-up are re-treated for 14-28 days; if lesions clear, patients may enter the maintenance protocol.
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| 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, Alabama | |||||
| Univ of Alabama at Birmingham | |||||
| Birmingham, Alabama, United States, 35294 | |||||
| United States, Arkansas | |||||
| Univ of Arkansas for Med Sciences | |||||
| Little Rock, Arkansas, United States, 72205 | |||||
| United States, California | |||||
| East Bay AIDS Ctr | |||||
| Berkeley, California, United States, 94705 | |||||
| Kaiser Permanente Med Ctr | |||||
| San Francisco, California, United States, 94115 | |||||
| United States, District of Columbia | |||||
| George Washington Univ Med Ctr | |||||
| Washington, District of Columbia, United States, 20037 | |||||
| Veterans Administration Med Ctr | |||||
| Washington, District of Columbia, United States, 20422 | |||||
| Dr Douglas Ward | |||||
| Washington, District of Columbia, United States, 20009 | |||||
| United States, Indiana | |||||
| Infectious Diseases Research Clinic / Indiana Univ Hosp | |||||
| Indianapolis, Indiana, United States, 46202 | |||||
| United States, Maryland | |||||
| Natl Inst of Allergy & Infect Dis / Cln Ctr | |||||
| Bethesda, Maryland, United States, 20892 | |||||
| United States, Michigan | |||||
| Wayne State Univ / Harper Hosp | |||||
| Detroit, Michigan, United States, 48201 | |||||
| Ann Arbor Veterans Administration Med Ctr | |||||
| Ann Arbor, Michigan, United States, 48105 | |||||
| United States, Missouri | |||||
| Washington Univ | |||||
| St. Louis, Missouri, United States, 63108 | |||||
| United States, Ohio | |||||
| Ohio State Univ Hosp | |||||
| Columbus, Ohio, United States, 43210 | |||||
| United States, Oklahoma | |||||
| Oklahoma City Veterans Administration Med Ctr | |||||
| Oklahoma City, Oklahoma, United States, 73104 | |||||
| United States, Pennsylvania | |||||
| Pennsylvania Hosp | |||||
| Philadelphia, Pennsylvania, United States, 19107 | |||||
| United States, Tennessee | |||||
| Infectious Disease Clinic | |||||
| Nashville, Tennessee, United States, 37212 | |||||
| United States, Texas | |||||
| Audie L Murphy Veterans Administration Hosp | |||||
| San Antonio, Texas, United States, 78284 | |||||
| United States, Virginia | |||||
| Univ of Virginia Health Sciences Ctr | |||||
| Charlottesville, Virginia, United States, 22908 | |||||
| Janssen, LP |
More Information
|
Moskovitz B, Wu J, Baruch A, Benken C. Long term safety and efficacy of itraconazole oral solution (IS) for treatment of fluconazole refractory oropharyngeal candidiasis (OC) in HIV-positive patients (pts). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:124 (abstract no 325)
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| Study ID Numbers: | 236B, ITR-USA-94 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002133 |
| Health Authority: | United States: Food and Drug Administration |
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