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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: HIV Infections; Candidiasis, Oral

Treatments: Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002133

236B

ITR-USA-94

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).