A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients

June 23, 2005 updated by: Schering-Plough

A Multicenter, Randomized, Double-Blind, Phase II Study to Evaluate the Safety, Tolerance and Efficacy of Multiple Doses of SCH 56592 Versus Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients

The purpose of this study is to compare the safety and effectiveness of SCH 56592 with that of fluconazole in the treatment of OPC (a fungal infection of the throat) in HIV-positive patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, multicenter, double-blind study consisting of 5 arms (4 dose levels of SCH 56592 vs fluconazole) in the treatment of oropharyngeal candidiasis (OPC) in HIV-positive patients.

Study Type

Interventional

Enrollment

500

Phase

  • Phase 2

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

  • Argentina
      • Buenos Aires, Argentina
        • Centro de Micologia / Facultad de Medicina UBA
      • Buenos Aires, Argentina
        • Hosp Fernandez
  • Belgium
      • Brussels, Belgium
        • CHU Saint Pierre
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • St Paul's Hosp
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Victoria Gen Hosp
    • Quebec
      • Montreal, Quebec, Canada
        • Montreal Gen Hosp
  • Chile
      • Santiago, Chile
        • Fundacion Arriaran
  • Dominican Republic
      • Ensanche NACO/ Santo Domingo, Dominican Republic
        • Avenida Lope de Vega Avenue esq/Calle Jose Amado Soler
  • Ethiopia
      • Addis Ababa, Ethiopia
        • Faculty of Medicine / Dept of Internal Medicine
  • France
      • Garches, France
        • Hôpital Raymond Poincaré
      • Maseille, France
        • Hopital de la Conception
      • Montpellier, France
        • Hopital Guy de Chauliac Service des Maladies Infectieuses
      • Nice, France
        • Service des Maladies Infectieuses Hopital de l Archet
      • Paris, France
        • Hopital Rothchild
      • Paris cedex, France
        • Hopital de l Institut Pasteur
      • Tours Cedex, France
        • Service des Maladies Infectieuses
      • Villejuif Cedex, France
        • Service des Maladies Infectieuses
  • Germany
      • Bonn, Germany
        • Rheinische Friedrich Wilhelms Universitaet Medizinische
      • Dusseldorf, Germany
        • Heinrich Heine Universitat
      • Hamburg, Germany
        • Allgemeines Krankenhaus St Georg
      • Hamburg, Germany
        • Universitaets Krankenhaus Eppendorf Medizinische Kernklinik
      • Kiel, Germany
        • Staedtisches Krankenhaus Kiel
      • Koln, Germany
        • Universitaet Klinik Koln
      • Munich 2, Germany
        • Universitat Munchen / Medizinische Poliklinik
  • Guatemala
      • Guatemala, Guatemala
        • Hosp Roosevelt Chief Infectious Diseases Unit
  • Honduras
      • San Pedro Sula, Honduras
        • Hosp Regional del Seguro Social
  • Israel
      • Tel Hashomer, Israel
        • Sheba Med Ctr
  • Mexico
      • Mexico, Mexico
        • Hosp de Especialidades Centro Medico La Raza
  • Panama
      • Panama, Panama
        • Royal Ctr
  • South Africa
      • Port Elizabeth, South Africa
        • Daniel Rudolph Malan
      • Rosebank, South Africa
        • The Studio
      • Tygerberg, South Africa
        • Univ of Stellenbosch Med School Depart Med Phys
  • Spain
      • Barcelona, Spain
        • Hosp Clinic
      • Barcelona, Spain
        • Hosp Valle D Hebron
  • Thailand
      • Bangkok, Thailand
        • Program on AIDS / Thai Red Cross Society
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85723
        • Tucson Veterans Administration Med Ctr
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Northeast Arkansas Clinic
    • Florida
      • Miami, Florida, United States, 33125
        • Miami Veterans Administration Med Ctr
      • Miami, Florida, United States, 33133
        • Mercy Hosp
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Ponce de Leon Med Ctr
      • Augusta, Georgia, United States, 30912
        • Med College of Georgia
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Med College / Rush Presbyterian - St Luke's Med Cen
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Wishard Hosp
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State Univ / Harper Hosp
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • St Michaels Med Ctr
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Univ Med Ctr
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson Univ / Division of Infectious Disease
    • Tennessee
      • Nashville, Tennessee, United States, 372321302
        • Vanderbilt Univ Med Ctr
    • Texas
      • Dallas, Texas, United States, 75390
        • Univ of Texas Southwestern Med Ctr
      • Houston, Texas, United States, 77030
        • Univ of Texas / Med School at Houston
      • San Antonio, Texas, United States, 78284
        • Univ of Texas Health Sciences Ctr
    • Washington
      • Tacoma, Washington, United States, 98405
        • Infections Ltd / Physicians Med Ctr
  • Venezuela
      • Caracas, Venezuela
        • Policlinica Metropolitana

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:

  • Documented HIV seropositivity (by Western blot or other approved confirmatory test) prior to enrollment.
  • Pseudomembranous oropharyngeal candidiasis.
  • Fungal stain or KOH consistent with Candida species, confirmed by a positive mycologic culture.
  • Ability to swallow study medication.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms and conditions are excluded:

  • Medical condition requiring use of prohibited drugs.
  • Primary HIV seroconversion-related mucosal candidiasis.
  • Systemic candidiasis.
  • All forms of OPC other than pseudomembranous (unless accompanied by pseudomembranous OPC).
  • Documented or suspected fungal esophagitis in patients with symptoms of esophagitis.
  • EKG with prolonged QTc interval or clinically-significant abnormalities.

Concurrent Medication:

Excluded:

  • Systemic antifungals (IV or oral).
  • Topical oral antifungals, e.g., Nystatin, Mycelex, etc.
  • Medications known to interact with azoles and that may lead to life-threatening side effects:
  • terfenadine, astemizole, cisapride, ebastine, triazolam, midazolam.
  • Medications known to lower the serum concentration/efficacy of azole antifungals:
  • rifampin, carbamazepine, phenytoin, rifabutin, barbiturates, isoniazid, H2 blockers.
  • Cytokines (except erythropoietin), interferon, or lymphocyte replacement therapy unless patient already taking these agents for at least 30 days prior to enrollment.
  • Protease inhibitors, starting for the first time, 30 days prior to study enrollment.
  • Cytotoxic therapy for cancer.
  • Oral or intravenous corticosteroids at supraphysiologic doses (prednisone 10 mg/day or greater; hydrocortisone 40 mg/day or greater; dexamethasone 2 mg/day or greater.

Patients with any of the following prior conditions are excluded:

  • Prior enrollment in this study.
  • Less than 3 months life expectancy.
  • History of hypersensitivity to azole antifungals.
  • History of failed therapy with fluconazole 100 mg/day for 2 weeks in the last 3 months.

Prior Medication:

Excluded (wash-outs for medications):

  • Systemic antifungals (IV, oral) within 14 days prior to enrollment.
  • Topical oral antifungals within 1 day prior to enrollment.
  • Oral or intravenous corticosteroids at supraphysiologic doses within 10 days prior to enrollment.
  • Astemizole within 10 days prior to enrollment.
  • Drugs known to lower the serum concentration/efficacy of azole antifungals within 30 days prior to enrollment.
  • Investigational drug (unlicensed new chemical entity) use within 30 days prior to enrollment.

Current known drug abuse, in the opinion of the lead investigator, that would interfere with the subject's participation in the study.

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 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

January 1, 1999

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 288A
  • C96-209
  • I96-209

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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