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Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.

This study has been completed.

Sponsored by: Janssen, LP
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002132
  Purpose

To evaluate the safety and efficacy of itraconazole oral solution versus fluconazole tablets for the treatment of esophageal candidiasis in immunocompromised patients.


Condition Intervention
Candidiasis, Esophageal
HIV Infections
Drug: Itraconazole
Drug: Fluconazole

MedlinePlus related topics:   AIDS    Esophagus Disorders    Yeast Infections   

ChemIDplus related topics:   Fluconazole    Itraconazole   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Double-Blind, Safety Study
Official Title:   Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.
  Eligibility
Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Patients must have:

  • Esophageal candidiasis.
  • Histological evidence of Candida spp. at baseline with confirmation by positive mycological culture.
  • HIV infection or other predisposing risk factor.
  • Life expectancy of at least 2 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Malignancies of the head or neck, if the treatment or disease will interfere with response assessment.
  • Evidence of systemic fungal infection.
  • Underlying clinical condition that would preclude study completion.
  • Judged to be unreliable in regard to following physician's directives.

Concurrent Medication:

Excluded:

  • Rifampin.
  • Rifabutin.
  • Phenobarbital.
  • Phenytoin.
  • Carbamazepine.
  • Terfenadine.
  • Astemizole.
  • H2 blockers.
  • Continual antacids.
  • Any investigational drug (expanded access drugs are allowed).

Patients with the following prior conditions are excluded:

  • History of significant hepatic abnormalities or clinical evidence of hepatic disease within 2 months prior to study entry.
  • History of hypersensitivity to imidazole or azole compounds.

Prior Medication:

Excluded:

  • Other orally administered antifungal therapy within 3 days prior to study entry.
  • Any investigational drug within 1 month prior to study entry (expanded access drugs are allowed).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002132

Locations
United States, Arizona
Dr Eskild A Petersen    
      Tucson, Arizona, United States, 85724
United States, California
UCSD Med Ctr    
      San Diego, California, United States, 92103
Los Angeles County - USC Med Ctr    
      Los Angeles, California, United States, 90033
United States, District of Columbia
George Washington Univ Med Ctr    
      Washington, District of Columbia, United States, 20037
United States, Georgia
Emory Univ School of Medicine    
      Atlanta, Georgia, United States, 30303
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr    
      Chicago, Illinois, United States, 60612
United States, Maryland
Johns Hopkins Univ School of Medicine    
      Baltimore, Maryland, United States, 21205
United States, Michigan
Wayne State Univ / Harper Hosp    
      Detroit, Michigan, United States, 48201
United States, Missouri
Univ of Missouri at Kansas City School of Medicine    
      Kansas City, Missouri, United States, 64108
Infectious Diseases Association / Research Med Ctr    
      Kansas City, Missouri, United States, 64132
United States, New York
Montefiore Med Ctr    
      Bronx, New York, United States, 10467
Dr Douglas Dieterich    
      New York, New York, United States, 10016
Erie County Med Ctr    
      Buffalo, New York, United States, 14215
United States, North Carolina
Univ of North Carolina    
      Chapel Hill, North Carolina, United States, 27599
Bowman Gray School of Medicine    
      Winston Salem, North Carolina, United States, 27157
United States, Ohio
Univ Hosps of Cleveland    
      Cleveland, Ohio, United States, 44106
United States, Texas
Austin Infectious Disease Consultants    
      Austin, Texas, United States, 78705
Houston Veterans Administration Med Ctr    
      Houston, Texas, United States, 77030

Sponsors and Collaborators
Janssen, LP
  More Information


Publications:

Study ID Numbers:   236A, ITR-USA-12
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002132
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Itraconazole  
Fluconazole  
Acquired Immunodeficiency Syndrome  
Candidiasis  
Immunocompromised Host  

Study placed in the following topic categories:
Fluconazole
Sexually Transmitted Diseases, Viral
Candidiasis
Esophageal disorder
Clotrimazole
Gastrointestinal Diseases
Miconazole
Acquired Immunodeficiency Syndrome
Tioconazole
Hydroxyitraconazole
Itraconazole
Immunologic Deficiency Syndromes
Virus Diseases
Mycoses
Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases
Esophageal 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 September 16, 2008




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