Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.

Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.

To evaluate the safety and efficacy of itraconazole oral solution versus fluconazole tablets for the treatment of esophageal candidiasis in immunocompromised patients.

Inclusion Criteria

Patients must have:

• Esophageal candidiasis.
• Histological evidence of Candida spp. at baseline with confirmation by positive mycological culture.
• HIV infection or other predisposing risk factor.
• Life expectancy of at least 2 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Malignancies of the head or neck, if the treatment or disease will interfere with response assessment.
• Evidence of systemic fungal infection.
• Underlying clinical condition that would preclude study completion.
• Judged to be unreliable in regard to following physician's directives.

Concurrent Medication:

Excluded:

• Rifampin.
• Rifabutin.
• Phenobarbital.
• Phenytoin.
• Carbamazepine.
• Terfenadine.
• Astemizole.
• H2 blockers.
• Continual antacids.
• Any investigational drug (expanded access drugs are allowed).

Patients with the following prior conditions are excluded:

• History of significant hepatic abnormalities or clinical evidence of hepatic disease within 2 months prior to study entry.
• History of hypersensitivity to imidazole or azole compounds.

Prior Medication:

Excluded:

• Other orally administered antifungal therapy within 3 days prior to study entry.
• Any investigational drug within 1 month prior to study entry (expanded access drugs are allowed).