Strep Throat |
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Clinical Trial: 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
This study has been completed.
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Purpose
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 | Treatment or Intervention |
|---|---|
| Candidiasis, Oral HIV Infections | Drug: Itraconazole |
MedlinePlus related topics: AIDS; Candidiasis
Study Type: Interventional
Study Design: Treatment, Open Label, Efficacy Study
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
Patients who responded to therapy on protocol FDA 236B receive maintenance with itraconazole oral solution for up to 6 months.
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: 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.
Location Information
Pennsylvania
Buckley Braffman Stern Med Associates, Philadelphia, Pennsylvania, 19107, United States
More Information
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)
Record last reviewed: April 1996
Last Updated: October 13, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00002341
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Group A Streptococcal Infections (Cleveland Clinic)
- Strep throat (Google Health)

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