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A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients Clinical research trials and A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients. A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients clinical trial. Participants frequently obtain the most expert healthcare available for their A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients  A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients
A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients
For Condition: Candidiasis, Oral,HIV Infections
Status: Completed
Sponsor(s): Schering-Plough ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 500
Location and Contact Information:
Infections Ltd / Physicians Med Ctr
Tacoma, Washington, 98405
United States
Univ of Stellenbosch Med School Depart Med Phys
Tygerberg, ,
South Africa
Fundacion Arriaran
Santiago, ,
Chile
St Paul's Hosp
Vancouver, British Columbia,
Canada
Hopital de l Institut Pasteur
Paris Cedex, ,
France
Staedtisches Krankenhaus Kiel
Kiel, ,
Germany
Rush Med College / Rush Presbyterian - St Luke's Med Cen
Chicago, Illinois, 60612
United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 372321302
United States
Faculty of Medicine / Dept of Internal Medicine
Addis Ababa, ,
Ethiopia
Universitaet Klinik Koln
Koln, ,
Germany
Hosp de Especialidades Centro Medico La Raza
Mexico, ,
Mexico
Univ of Texas Southwestern Med Ctr
Dallas, Texas, 75390
United States
Daniel Rudolph Malan
Port Elizabeth, ,
South Africa
Miami Veterans Administration Med Ctr
Miami, Florida, 33125
United States
Service des Maladies Infectieuses
Tours Cedex, ,
France
Royal Ctr
Panama, ,
Panama
Allgemeines Krankenhaus St Georg
Hamburg, ,
Germany
Rheinische Friedrich Wilhelms Universitaet Medizinische
Bonn, ,
Germany
Hopital Raymond Poincare
Garches, ,
France
Hopital Guy de Chauliac Service des Maladies Infectieuses
Montpellier, ,
France
Northeast Arkansas Clinic
Jonesboro, Arkansas, 72401
United States
Avenida Lope de Vega Avenue esq/Calle Jose Amado Soler
Ensanche NACO/ Santo Domingo, ,
Dominican Republic
Thomas Jefferson Univ / Division of Infectious Disease
Philadelphia, Pennsylvania, 19107
United States
Hopital Rothchild
Paris, ,
France
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Univ of Texas Health Sciences Ctr
San Antonio, Texas, 78284
United States
Mercy Hosp
Miami, Florida, 33133
United States
Montreal Gen Hosp
Montreal, Quebec,
Canada
Hosp Valle D Hebron
Barcelona, ,
Spain
Universitat Munchen / Medizinische Poliklinik
Munich 2, ,
Germany
Universitaets Krankenhaus Eppendorf Medizinische Kernklinik
Hamburg, ,
Germany
Hosp Regional del Seguro Social
San Pedro Sula, ,
Honduras
Service des Maladies Infectieuses
Villejuif Cedex, ,
France
Med College of Georgia
Augusta, Georgia, 30912
United States
CHU Saint Pierre
Brussels, ,
Belgium
Victoria Gen Hosp
Halifax, Nova Scotia,
Canada
Hosp Clinic
Barcelona, ,
Spain
Hopital de La Conception
Maseille, ,
France
Wishard Hosp
Indianapolis, Indiana, 46202
United States
The Studio
Rosebank, ,
South Africa
Policlinica Metropolitana
Caracas, ,
Venezuela
Heinrich Heine Universitat
Dusseldorf, ,
Germany
Univ of Texas / Med School at Houston
Houston, Texas, 77030
United States
Service des Maladies Infectieuses Hopital de l Archet
Nice, ,
France
Sheba Med Ctr
Tel Hashomer, ,
Israel
Tucson Veterans Administration Med Ctr
Tucson, Arizona, 85723
United States
Ponce de Leon Med Ctr
Atlanta, Georgia, 30308
United States
Hosp Roosevelt Chief Infectious Diseases Unit
Guatemala, ,
Guatemala
Hosp Fernandez
Buenos Aires, ,
Argentina
Program on AIDS / Thai Red Cross Society
Bangkok, ,
Thailand
Wayne State Univ / Harper Hosp
Detroit, Michigan, 48201
United States
St Michaels Med Ctr
Newark, New Jersey, 07102
United States
Centro de Micologia / Facultad de Medicina UBA
Buenos Aires, ,
Argentina
Additional Information:
Study ID Numbers: 288A; C96-209,I96-209
Study Start Date:
Record last reviewed: January 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002399
Other Hiv Infections Studies:
1. Safety and Effectiveness of Fluconazole Versus SCH 56592 to Treat Thrush in HIV-Positive Patients
2. An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.
3. A Comparison of the Safety and Effectiveness of Fluconazole or Clotrimazole in the Treatment of Fungal Infections of the Mouth and Throat in Patients with AIDS
4. Safety and Effectiveness of Giving L-743,872 to Patients with Thrush That Has Not Been Cured With Fluconazole
5. Oral Manifestations of Human Immunodeficiency Virus Infection in High Risk Groups
Related Studies:
Other HIV Infections Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients
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