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.
Sponsor:
Janssen, LP
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002341
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1996
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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 | Intervention |
---|---|
Candidiasis, Oral HIV Infections |
Drug: Itraconazole |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Efficacy Study Masking: 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 |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
![](https://webarchive.library.unt.edu/web/20130312000537im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
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![](https://webarchive.library.unt.edu/web/20130312000537im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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)
ClinicalTrials.gov Identifier: | NCT00002341 History of Changes |
Other Study ID Numbers: | 236C, ITR-USA-107 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Itraconazole Acquired Immunodeficiency Syndrome AIDS-Related Complex Candidiasis, Oral |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome 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 Slow Virus Diseases |
Mycoses Mouth Diseases Stomatognathic Diseases Fluconazole Itraconazole Hydroxyitraconazole Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on March 10, 2013