Safety and Effectiveness of Fluconazole Versus SCH 56592 to Treat Thrush in HIV-Positive Patients

June 23, 2005 updated by: Schering-Plough

Randomized, Controlled Trial of SCH 56592 Oral Suspension Versus Fluconazole Suspension in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients

The purpose of this study is to compare the safety and effectiveness of 2 treatments for thrush (a fungal infection of the mouth and throat) in HIV-positive patients. Fluconazole is a drug that is commonly used to treat thrush. SCH 56592 is a new drug that will be compared to fluconazole.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients receive SCH 56592 oral suspension or fluconazole suspension for 14 days. Patients remain on study for 44 days total and are monitored for safety and efficacy of study treatment.

Study Type

Interventional

Enrollment

300

Phase

  • Phase 3

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

  • Barbados
      • St Michael, Barbados
        • Queen Elizabeth Hosp Respiratory Unit
  • United States
    • California
      • Berkeley, California, United States, 94705
        • East Bay AIDS Ctr
      • San Francisco, California, United States, 94109
        • ViRx Inc
      • San Francisco, California, United States, 94118
        • Kaiser Foundation Hospital
    • Colorado
      • Denver, Colorado, United States, 80204
        • Infectious Disease and AIDS Clinic
    • District of Columbia
      • Washington, District of Columbia, United States, 200091104
        • Dupont Circle Physicians Group
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Boulevard Comprehensive Care Ctr
      • Miami, Florida, United States, 33125
        • Miami Veterans Administration Med Ctr
    • Illinois
      • Chicago, Illinois, United States, 60657
        • TRIAD Health Practice
    • Indiana
      • Indianapolis, Indiana, United States, 46219
        • Community Hosp Indianapolis
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State Univ / Harper Hosp
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • UMDNJ - New Jersey Med School / Cooper Hosp
      • Jersey City, New Jersey, United States, 07304
        • Jersey City Med Ctr
    • New York
      • Brooklyn, New York, United States, 11203
        • SUNY / Health Science Ctr at Brooklyn
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Univ of Pennsylvania School of Dental Medicine
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Med Univ of South Carolina
    • Texas
      • Dallas, Texas, United States, 75235
        • Amelia Ct Clinic
      • San Antonio, Texas, United States, 78284
        • Univ of Texas 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

You may be eligible for this study if you:

  • Are at least 18 years old.
  • Are HIV-positive.
  • Have thrush (oropharyngeal candidiasis).
  • Agree to practice sexual abstinence or use effective barrier methods of birth control (e.g., condoms).
  • Are able to take study medication and return for clinic visits during the study.
  • Are expected to live for at least 2 months.

Exclusion Criteria

You will not be eligible for this study if you:

  • Have received protease inhibitors for the first time within 30 days prior to study entry.
  • Have received certain medications.
  • Have certain other types of fungal infections.
  • Have certain types of cancer.
  • Have received SCH 56592 within 3 months prior to study entry.
  • Are pregnant or breast-feeding.
  • Cannot take medications by mouth.
  • Are allergic to azole drugs.
  • Have certain medical conditions.
  • Have been in this study before.

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: Double

Collaborators and Investigators

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

Sponsor

Schering-Plough

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 Major Dates

Study Start

August 1, 1998

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

February 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 305A
  • C97-331
  • I97-331

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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