An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.

June 23, 2005 updated by: Janssen, LP
To assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients with oropharyngeal candidiasis that is refractory to fluconazole.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Univ of Alabama at Birmingham
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Univ of Arkansas for Med Sciences
    • California
      • Berkeley, California, United States, 94705
        • East Bay AIDS Ctr
      • San Francisco, California, United States, 94115
        • Kaiser Permanente Med Ctr
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington Univ Med Ctr
      • Washington, District of Columbia, United States, 20422
        • Veterans Administration Med Ctr
      • Washington, District of Columbia, United States, 20009
        • Dr Douglas Ward
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Infectious Diseases Research Clinic / Indiana Univ Hosp
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Natl Inst of Allergy & Infect Dis / Cln Ctr
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Ann Arbor Veterans Administration Med Ctr
      • Detroit, Michigan, United States, 48201
        • Wayne State Univ / Harper Hosp
    • Missouri
      • St. Louis, Missouri, United States, 63108
        • Washington Univ
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State Univ Hosp
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma City Veterans Administration Med Ctr
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Pennsylvania Hosp
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Infectious disease clinic
    • Texas
      • San Antonio, Texas, United States, 78284
        • Audie L Murphy Veterans Administration Hosp
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Univ of Virginia Health Sciences Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen, LP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

April 1, 1996

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 236B
  • ITR-USA-94

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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