An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.
Candidiasis, Oral, HIV Infections
About this trial
This is an interventional treatment trial for Candidiasis, Oral focused on measuring Itraconazole, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Candidiasis, Oral
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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).
Sites / Locations
- Univ of Alabama at Birmingham
- Univ of Arkansas for Med Sciences
- East Bay AIDS Ctr
- Kaiser Permanente Med Ctr
- Dr Douglas Ward
- George Washington Univ Med Ctr
- Veterans Administration Med Ctr
- Infectious Diseases Research Clinic / Indiana Univ Hosp
- Natl Inst of Allergy & Infect Dis / Cln Ctr
- Ann Arbor Veterans Administration Med Ctr
- Wayne State Univ / Harper Hosp
- Washington Univ
- Ohio State Univ Hosp
- Oklahoma City Veterans Administration Med Ctr
- Pennsylvania Hosp
- Infectious Disease Clinic
- Audie L Murphy Veterans Administration Hosp
- Univ of Virginia Health Sciences Ctr