An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00002133 |
Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Candidiasis, Oral HIV Infections | Drug: Itraconazole | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects. |


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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
- HIV antibody seropositivity or diagnosis of AIDS.
- Confirmed oropharyngeal candidiasis.
- Failed fluconazole treatment within the past 14 days.
- Life expectancy of at least 3 months.
- NO symptoms of esophageal candidiasis (e.g., dysphagia) unless endoscopic exam of esophagus was performed and fungal esophagitis was not present.
- NO prior disseminated candidiasis.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Underlying clinical condition that precludes study completion or places the patient at significant risk.
- Considered unreliable about following physician's directives.
Concurrent Medication:
Excluded:
- Investigational drugs (approved expanded access drugs are permitted).
- Rifampin.
- Rifabutin.
- Phenobarbital.
- Phenytoin.
- Carbamazepine.
- Terfenadine.
- Astemizole.
Patients with the following prior conditions are excluded:
- History of hypersensitivity to imidazole or azole compounds.
- Clinical evidence of significant hepatic disease within the past 2 months.
Prior Medication:
Excluded:
- Investigational drugs within 1 month prior to study entry (approved expanded access drugs are permitted).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002133

ClinicalTrials.gov Identifier: | NCT00002133 |
Other Study ID Numbers: |
236B ITR-USA-94 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | April 1996 |
Itraconazole Acquired Immunodeficiency Syndrome AIDS-Related Complex Candidiasis, Oral |
Candidiasis Candidiasis, Oral Mycoses Mouth Diseases Stomatognathic Diseases Itraconazole Antifungal Agents Anti-Infective Agents 14-alpha Demethylase Inhibitors |
Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP3A Inhibitors |