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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| ClinicalTrials.gov Identifier: NCT00002133 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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Sponsor:
Janssen, LP
Information provided by:
NIH AIDS Clinical Trials Information Service
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Brief Summary:
To assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients with oropharyngeal candidiasis that is refractory to fluconazole.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Candidiasis, Oral HIV Infections | Drug: Itraconazole | Not Applicable |
Patients receive itraconazole oral solution twice daily. Per 08/15/94 amendment, patients with complete resolution of oropharyngeal candidiasis lesions upon completion of treatment are eligible for maintenance treatment on protocol FDA 236C. Patients who decline maintenance are followed for 6 weeks. Patients who relapse during follow-up are re-treated for 14-28 days; if lesions clear, patients may enter the maintenance protocol.
| 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 |
Criteria
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).
Information from the National Library of Medicine
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
Locations
| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arkansas | |
| Univ of Arkansas for Med Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| East Bay AIDS Ctr | |
| Berkeley, California, United States, 94705 | |
| Kaiser Permanente Med Ctr | |
| San Francisco, California, United States, 94115 | |
| United States, District of Columbia | |
| Dr Douglas Ward | |
| Washington, District of Columbia, United States, 20009 | |
| George Washington Univ Med Ctr | |
| Washington, District of Columbia, United States, 20037 | |
| Veterans Administration Med Ctr | |
| Washington, District of Columbia, United States, 20422 | |
| United States, Indiana | |
| Infectious Diseases Research Clinic / Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Maryland | |
| Natl Inst of Allergy & Infect Dis / Cln Ctr | |
| Bethesda, Maryland, United States, 20892 | |
| United States, Michigan | |
| Ann Arbor Veterans Administration Med Ctr | |
| Ann Arbor, Michigan, United States, 48105 | |
| Wayne State Univ / Harper Hosp | |
| Detroit, Michigan, United States, 48201 | |
| United States, Missouri | |
| Washington Univ | |
| St. Louis, Missouri, United States, 63108 | |
| United States, Ohio | |
| Ohio State Univ Hosp | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oklahoma | |
| Oklahoma City Veterans Administration Med Ctr | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| Pennsylvania Hosp | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Tennessee | |
| Infectious Disease Clinic | |
| Nashville, Tennessee, United States, 37212 | |
| United States, Texas | |
| Audie L Murphy Veterans Administration Hosp | |
| San Antonio, Texas, United States, 78284 | |
| United States, Virginia | |
| Univ of Virginia Health Sciences Ctr | |
| Charlottesville, Virginia, United States, 22908 | |
Sponsors and Collaborators
Janssen, LP
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)
| ClinicalTrials.gov Identifier: | NCT00002133 History of Changes |
| 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 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
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Itraconazole Acquired Immunodeficiency Syndrome AIDS-Related Complex Candidiasis, Oral |
Additional relevant MeSH terms:
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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 Cytochrome P-450 CYP2C19 Inhibitors |