An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.

Completed · Not applicable

Conditions studied: Candidiasis, Oral, HIV Infections

In brief

To assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients with oropharyngeal candidiasis that is refractory to fluconazole.

Key facts

Study ID

NCT00002133

Run by

Janssen, LP

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Underlying clinical condition that precludes study completion or places the patient at significant risk.
• Considered unreliable about following physician's directives.
• Concurrent Medication:
• Excluded:
• Investigational drugs (approved expanded access drugs are permitted).
• Rifampin.
• Rifabutin.
• Phenobarbital.
• Phenytoin.
• Carbamazepine.
• Terfenadine.
• Astemizole.
• Patients with the following prior conditions are excluded:
• History of hypersensitivity to imidazole or azole compounds.
• Clinical evidence of significant hepatic disease within the past 2 months.
• Prior Medication:
• Excluded:
• Investigational drugs within 1 month prior to study entry (approved expanded access drugs are permitted).

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• Univ of Arkansas for Med Sciences — Little Rock, Arkansas, United States
• East Bay AIDS Ctr — Berkeley, California, United States
• Kaiser Permanente Med Ctr — San Francisco, California, United States
• Dr Douglas Ward — Washington D.C., District of Columbia, United States
• George Washington Univ Med Ctr — Washington D.C., District of Columbia, United States
• Veterans Administration Med Ctr — Washington D.C., District of Columbia, United States
• Infectious Diseases Research Clinic / Indiana Univ Hosp — Indianapolis, Indiana, United States
• Natl Inst of Allergy & Infect Dis / Cln Ctr — Bethesda, Maryland, United States
• Ann Arbor Veterans Administration Med Ctr — Ann Arbor, Michigan, United States
• Wayne State Univ / Harper Hosp — Detroit, Michigan, United States
• Washington Univ — St Louis, Missouri, United States
• Ohio State Univ Hosp — Columbus, Ohio, United States
• Oklahoma City Veterans Administration Med Ctr — Oklahoma City, Oklahoma, United States
• Pennsylvania Hosp — Philadelphia, Pennsylvania, United States
• Infectious Disease Clinic — Nashville, Tennessee, United States
• Audie L Murphy Veterans Administration Hosp — San Antonio, Texas, United States
• Univ of Virginia Health Sciences Ctr — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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