A Study of Treatments for Fungal Infections of the Mouth and Throat in HIV-Infected Patients Who Have Had Success With Itraconazole But Not With Fluconazole

June 23, 2005 updated by: Janssen, LP

An Open-Label Extension Study of Maintenance Therapy in HIV-Positive Subjects With Fluconazole-Refractory Oropharyngeal Candidiasis Who Have Responded to Itraconazole Oral Solution

To provide maintenance treatment with itraconazole solution for patients who were clinical responders in the ITR-USA-94 protocol, even if they subsequently relapsed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients who responded to therapy on protocol FDA 236B receive maintenance with itraconazole oral solution for up to 6 months.

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Buckley Braffman Stern Med Associates

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:

  • Met criteria for clinical response on protocol FDA 236B with no residual visible lesion of oropharyngeal candidiasis upon completion of that study OR had initial response on protocol FDA 236B with subsequent relapse and retreatment with itraconazole solution or other therapies.
  • Life expectancy of at least 3 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Underlying clinical condition that would preclude completion of study or place subject at significant risk.
  • Judged unreliable with respect to physician's directives.

Concurrent Medication:

Excluded:

  • Rifampin.
  • Rifabutin.
  • Phenobarbital.
  • Phenytoin.
  • Carbamazepine.
  • Terfenadine.
  • Astemizole.
  • Systemic antifungals.

Patients with the following prior conditions are excluded:

  • Previously documented disseminated candidiasis.
  • Previous clinically significant adverse event during treatment with itraconazole oral solution, unless clearly attributable to an intercurrent illness or condition.
  • History of significant hepatic abnormalities or clinical evidence of significant hepatic disease within 2 months prior to study entry.

Prior Medication:

Excluded:

  • Any investigational drug (other than itraconazole solution) within 1 month prior to study entry.

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

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

  • 236C
  • ITR-USA-107

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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