A Study of Treatments for Fungal Infections of the Mouth and Throat in HIV-Infected Patients Who Have Had Success With Itraconazole But Not With Fluconazole

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: HIV Infections; Candidiasis, Oral

Treatments: Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002341

236C

ITR-USA-107

Details and patient eligibility

About

To provide maintenance treatment with itraconazole solution for patients who were clinical responders in the ITR-USA-94 protocol, even if they subsequently relapsed.

Full description

Patients who responded to therapy on protocol FDA 236B receive maintenance with itraconazole oral solution for up to 6 months.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Patients must have:

• Met criteria for clinical response on protocol FDA 236B with no residual visible lesion of oropharyngeal candidiasis upon completion of that study OR had initial response on protocol FDA 236B with subsequent relapse and retreatment with itraconazole solution or other therapies.
• Life expectancy of at least 3 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Underlying clinical condition that would preclude completion of study or place subject at significant risk.
• Judged unreliable with respect to physician's directives.

Concurrent Medication:

Excluded:

• Rifampin.
• Rifabutin.
• Phenobarbital.
• Phenytoin.
• Carbamazepine.
• Terfenadine.
• Astemizole.
• Systemic antifungals.

Patients with the following prior conditions are excluded:

• Previously documented disseminated candidiasis.
• Previous clinically significant adverse event during treatment with itraconazole oral solution, unless clearly attributable to an intercurrent illness or condition.
• History of significant hepatic abnormalities or clinical evidence of significant hepatic disease within 2 months prior to study entry.

Prior Medication:

Excluded:

• Any investigational drug (other than itraconazole solution) within 1 month prior to study entry.