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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002132
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1996
  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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.

Resource links provided by NLM:


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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
UCSD Med Ctr
San Diego, California, United States, 92103
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
Erie County Med Ctr
Buffalo, New York, United States, 14215
Dr Douglas Dieterich
New York, New York, United States, 10016
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 Pharmaceuticals
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00002132     History of Changes
Other Study ID Numbers: 236A, ITR-USA-12
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Candidiasis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Mycoses
Itraconazole
Hydroxyitraconazole
Fluconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014