A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients
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
3 other identifiers
interventional
500
18 countries
53
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
January 1, 1999
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Schering-Ploughlead
Study Sites (53)
Tucson Veterans Administration Med Ctr
Tucson, Arizona, 85723, United States
Northeast Arkansas Clinic
Jonesboro, Arkansas, 72401, United States
Miami Veterans Administration Med Ctr
Miami, Florida, 33125, United States
Mercy Hosp
Miami, Florida, 33133, United States
Ponce de Leon Med Ctr
Atlanta, Georgia, 30308, United States
Med College of Georgia
Augusta, Georgia, 30912, United States
Rush Med College / Rush Presbyterian - St Luke's Med Cen
Chicago, Illinois, 60612, United States
Wishard Hosp
Indianapolis, Indiana, 46202, United States
Wayne State Univ / Harper Hosp
Detroit, Michigan, 48201, United States
St Michaels Med Ctr
Newark, New Jersey, 07102, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Thomas Jefferson Univ / Division of Infectious Disease
Philadelphia, Pennsylvania, 19107, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 372321302, United States
Univ of Texas Southwestern Med Ctr
Dallas, Texas, 75390, United States
Univ of Texas / Med School at Houston
Houston, Texas, 77030, United States
Univ of Texas Health Sciences Ctr
San Antonio, Texas, 78284, United States
Infections Ltd / Physicians Med Ctr
Tacoma, Washington, 98405, United States
Centro de Micologia / Facultad de Medicina UBA
Buenos Aires, Argentina
Hosp Fernandez
Buenos Aires, Argentina
CHU Saint Pierre
Brussels, Belgium
St Paul's Hosp
Vancouver, British Columbia, Canada
Victoria Gen Hosp
Halifax, Nova Scotia, Canada
Montreal Gen Hosp
Montreal, Quebec, Canada
Fundacion Arriaran
Santiago, Chile
Avenida Lope de Vega Avenue esq/Calle Jose Amado Soler
Ensanche Naco/ Santo Domingo, Dominican Republic
Faculty of Medicine / Dept of Internal Medicine
Addis Ababa, Ethiopia
Hopital Raymond Poincare
Garches, France
Hopital de La Conception
Maseille, France
Hopital Guy de Chauliac Service des Maladies Infectieuses
Montpellier, France
Service des Maladies Infectieuses Hopital de l Archet
Nice, France
Hopital de l Institut Pasteur
Paris, France
Hopital Rothchild
Paris, France
Service des Maladies Infectieuses
Tours, France
Service des Maladies Infectieuses
Villejuif, France
Rheinische Friedrich Wilhelms Universitaet Medizinische
Bonn, Germany
Universitaet Klinik Koln
Cologne, Germany
Heinrich Heine Universitat
Düsseldorf, Germany
Allgemeines Krankenhaus St Georg
Hamburg, Germany
Universitaets Krankenhaus Eppendorf Medizinische Kernklinik
Hamburg, Germany
Staedtisches Krankenhaus Kiel
Kiel, Germany
Universitat Munchen / Medizinische Poliklinik
Munich, Germany
Hosp Roosevelt Chief Infectious Diseases Unit
Guatemala City, Guatemala
Hosp Regional del Seguro Social
San Pedro Sula, Honduras
Sheba Med Ctr
Tel Litwinsky, Israel
Hosp de Especialidades Centro Medico La Raza
México, Mexico
Royal Ctr
Panama City, Panama
Daniel Rudolph Malan
Port Elizabeth, South Africa
The Studio
Rosebank, South Africa
Univ of Stellenbosch Med School Depart Med Phys
Tygerberg, South Africa
Hosp Clinic
Barcelona, Spain
Hosp Valle D Hebron
Barcelona, Spain
Program on AIDS / Thai Red Cross Society
Bangkok, Thailand
Policlinica Metropolitana
Caracas, Venezuela
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1999-01