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
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Candidiasis, Oral; HIV Infections
Intervention: Itraconazole (Drug)
Phase: N/A
Status: Completed
Sponsored by: Janssen, LP
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.
Clinical Details
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
Study design: Treatment, Open Label, Efficacy Study
Detailed description:
Patients who responded to therapy on protocol FDA 236B receive maintenance with itraconazole
oral solution for up to 6 months.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Buckley Braffman Stern Med Associates, Philadelphia, Pennsylvania 19107, United States
Additional Information
Related publications: Moskovitz B, Wu J, Baruch A, Benken C. Long term safety and efficacy of itraconazole oral solution (IS) for treatment of fluconazole refractory oropharyngeal candidiasis (OC) in HIV-positive patients (pts). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:124 (abstract no 325) Fessel WJ, Merrill KW, Ward D, Moskovitz B, Benken C, Oleka N, Grimwood H. Itraconazole oral solution (IS) for the treatment of fluconazole-refractory oropharyngeal candidiasis (OC) in HIV-positive patients. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:124 (abstract no 327)
Last updated: June 23, 2005
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