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

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

Study Type: Interventional

Study Design: Treatment, Open Label, Safety Study

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.

Intervention(s) in this Clinical Trial

• Drug: Itraconazole

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).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Janssen, LP

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002133

Study ID Number: 236B

ClinicalTrials.gov Identifier: NCT00002133

Health Authority: United States: Food and Drug Administration