An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 1996
History of Changes
To assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients with oropharyngeal candidiasis that is refractory to fluconazole.
Drug : Itraconazole
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
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|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Patients must have:
- HIV antibody seropositivity or diagnosis of AIDS.
- Confirmed oropharyngeal candidiasis.
- Failed fluconazole treatment within the past 14 days.
- Life expectancy of at least 3 months.
- NO symptoms of esophageal candidiasis (e.g., dysphagia) unless endoscopic exam of esophagus was performed and fungal esophagitis was not present.
- NO prior disseminated candidiasis.
- Underlying clinical condition that precludes study completion or places the patient at significant risk.
- Considered unreliable about following physician's directives.
- Investigational drugs (approved expanded access drugs are permitted).
- History of hypersensitivity to imidazole or azole compounds.
- Clinical evidence of significant hepatic disease within the past 2 months.
- Investigational drugs within 1 month prior to study entry (approved expanded access
Patients with the following symptoms or conditions are excluded:
Patients with the following prior conditions are excluded:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002133
Locations Show More
|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|
|Dr Douglas Ward|
|Washington, District of Columbia, United States, 20009|
|George Washington Univ Med Ctr|
|Washington, District of Columbia, United States, 20037|
|Veterans Administration Med Ctr|
|Washington, District of Columbia, United States, 20422|
|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|
|Ann Arbor Veterans Administration Med Ctr|
|Ann Arbor, Michigan, United States, 48105|
|Wayne State Univ / Harper Hosp|
|Detroit, Michigan, United States, 48201|
|United States, Missouri|
|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|
|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|
Sponsors and CollaboratorsJanssen, LP
|Responsible Party:||Janssen, LP|
|ClinicalTrials.gov Identifier:||NCT00002133 History of Changes|
|Other Study ID Numbers:||236B|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Itraconazole
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on January 19, 2018
This information is provided by ClinicalTrials.gov.