An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.
2 other identifiers
interventional
N/A
1 country
18
Brief Summary
To assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients with oropharyngeal candidiasis that is refractory to fluconazole.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
April 1, 1996
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen, LPlead
Study Sites (18)
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
Dr Douglas Ward
Washington D.C., District of Columbia, 20009, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037, United States
Veterans Administration Med Ctr
Washington D.C., District of Columbia, 20422, 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
Ann Arbor Veterans Administration Med Ctr
Ann Arbor, Michigan, 48105, United States
Wayne State Univ / Harper Hosp
Detroit, Michigan, 48201, 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
Related Publications (1)
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)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1996-04