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
Completed · Not applicable
Conditions studied: Candidiasis, Oral, HIV Infections
In brief
To provide maintenance treatment with itraconazole solution for patients who were clinical responders in the ITR-USA-94 protocol, even if they subsequently relapsed.
Key facts
- Study ID
- NCT00002341
- Run by
- Janssen, LP
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Buckley Braffman Stern Med Associates — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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