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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
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

Study Description
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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

Detailed Description:
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 Design
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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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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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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).
Contacts and Locations
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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
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Sponsors and Collaborators
Janssen, LP
More Information
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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)

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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
Keywords provided by NIH AIDS Clinical Trials Information Service:
Itraconazole
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Candidiasis, Oral
Additional relevant MeSH terms:
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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