An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.
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To assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients with oropharyngeal candidiasis that is refractory to fluconazole.
Condition or disease
Candidiasis, OralHIV Infections
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.
Investigational drugs (approved expanded access drugs are permitted).
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.
Investigational drugs within 1 month prior to study entry (approved expanded access drugs are permitted).
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)