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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.

This study has been completed.

Sponsored by: Janssen, LP
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002133
  Purpose

To assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients with oropharyngeal candidiasis that is refractory to fluconazole.


Condition Intervention
Candidiasis, Oral
HIV Infections
Drug: Itraconazole

MedlinePlus related topics:   AIDS    Yeast Infections   

ChemIDplus related topics:   Fluconazole    Itraconazole   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Safety Study
Official Title:   An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.

Further study details as provided by NIH AIDS Clinical Trials Information Service:

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
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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
George Washington Univ Med Ctr    
      Washington, District of Columbia, United States, 20037
Veterans Administration Med Ctr    
      Washington, District of Columbia, United States, 20422
Dr Douglas Ward    
      Washington, District of Columbia, United States, 20009
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
Wayne State Univ / Harper Hosp    
      Detroit, Michigan, United States, 48201
Ann Arbor Veterans Administration Med Ctr    
      Ann Arbor, Michigan, United States, 48105
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
  More Information

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)

Study ID Numbers:   236B, ITR-USA-94
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002133
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  

Study placed in the following topic categories:
Fluconazole
Mouth Diseases
Candidiasis, Oral
Sexually Transmitted Diseases, Viral
Candidiasis
Clotrimazole
Miconazole
Acquired Immunodeficiency Syndrome
Tioconazole
AIDS-Related Complex
Hydroxyitraconazole
Itraconazole
Immunologic Deficiency Syndromes
Virus Diseases
Mycoses
HIV Seropositivity
HIV Infections
Sexually Transmitted Diseases
Stomatognathic Diseases
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Therapeutic Uses
Antifungal Agents
Lentivirus Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2008




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