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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002399
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: January 1999
  Purpose

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.


Condition Intervention Phase
Candidiasis, Oral
HIV Infections
Drug: Posaconazole
Drug: Fluconazole
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 500
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002399

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

No publications provided

ClinicalTrials.gov Identifier: NCT00002399     History of Changes
Other Study ID Numbers: 288A, C96-209, I96-209
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Fluconazole
Antifungal Agents
Candidiasis
Triazoles

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Candidiasis
Candidiasis, Oral
HIV Infections
HIV Seropositivity
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Mouth Diseases
Mycoses
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Stomatognathic Diseases
Virus Diseases
Fluconazole
Posaconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Trypanocidal Agents

ClinicalTrials.gov processed this record on October 20, 2014