An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Candidiasis, Oral; HIV Infections
Intervention: Itraconazole (Drug)
Phase: N/A
Status: Completed
Sponsored by: Janssen, LP
Summary
To assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients
with oropharyngeal candidiasis that is refractory to fluconazole.
Clinical Details
Official title: An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.
Study design: Treatment, Open Label, Safety Study
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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).
Locations and Contacts
Univ of Alabama at Birmingham, Birmingham, Alabama 35294, United States
Univ of Arkansas for Med Sciences, Little Rock, Arkansas 72205, United States
East Bay AIDS Ctr, Berkeley, California 94705, United States
Kaiser Permanente Med Ctr, San Francisco, California 94115, United States
George Washington Univ Med Ctr, Washington, District of Columbia 20037, United States
Veterans Administration Med Ctr, Washington, District of Columbia 20422, United States
Dr Douglas Ward, Washington, District of Columbia 20009, United States
Infectious Diseases Research Clinic / Indiana Univ Hosp, Indianapolis, Indiana 46202, United States
Natl Inst of Allergy & Infect Dis / Cln Ctr, Bethesda, Maryland 20892, United States
Wayne State Univ / Harper Hosp, Detroit, Michigan 48201, United States
Ann Arbor Veterans Administration Med Ctr, Ann Arbor, Michigan 48105, United States
Washington Univ, St. Louis, Missouri 63108, United States
Ohio State Univ Hosp, Columbus, Ohio 43210, United States
Oklahoma City Veterans Administration Med Ctr, Oklahoma City, Oklahoma 73104, United States
Pennsylvania Hosp, Philadelphia, Pennsylvania 19107, United States
Infectious Disease Clinic, Nashville, Tennessee 37212, United States
Audie L Murphy Veterans Administration Hosp, San Antonio, Texas 78284, United States
Univ of Virginia Health Sciences Ctr, Charlottesville, Virginia 22908, United States
Additional Information
Related 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)
Last updated: June 23, 2005
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