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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceuticals
• Treatments: Fluconazole; Hydroxyitraconazole; Itraconazole

Criteria

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).