Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen, LP
Treatments:
Fluconazole
Hydroxyitraconazole
Itraconazole
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.