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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Candidiasis, Esophageal; HIV Infections

Treatments: Drug: Itraconazole; Drug: Fluconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002132

ITR-USA-12

236A

Details and patient eligibility

About

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

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).