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

Sponsor

Janssen, LP (Industry)

Overall Status

Completed

CT.gov ID

NCT00002341

Collaborator

(none)

Location

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Candidiasis, Oral HIV Infections	Drug: Itraconazole	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label Extension Study of Maintenance Therapy in HIV-Positive Subjects With Fluconazole-Refractory Oropharyngeal Candidiasis Who Have Responded to Itraconazole Oral Solution

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.