A Study of Treatments for Fungal Infections of the Mouth and Throat in HIV-Infected Patients Who … (NCT00002341) | Clinical Trial Compass
CompletedNot Applicable
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
United States
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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.