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
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ClinicalTrials.gov Identifier: NCT00002341 |
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-Label Extension Study of Maintenance Therapy in HIV-Positive Subjects With Fluconazole-Refractory Oropharyngeal Candidiasis Who Have Responded to Itraconazole Oral Solution |

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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): NCT00002341
United States, Pennsylvania | |
Buckley Braffman Stern Med Associates | |
Philadelphia, Pennsylvania, United States, 19107 |
Publications:
ClinicalTrials.gov Identifier: | NCT00002341 History of Changes |
Other Study ID Numbers: |
236C ITR-USA-107 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | April 1996 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Itraconazole Acquired Immunodeficiency Syndrome AIDS-Related Complex Candidiasis, Oral |
Additional relevant MeSH terms:
Infection HIV Infections Candidiasis Candidiasis, Oral Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Mycoses Mouth Diseases Stomatognathic Diseases |
Itraconazole Hydroxyitraconazole Fluconazole 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 Cytochrome P-450 CYP2C9 Inhibitors |