Safety and Effectiveness of Fluconazole Versus SCH 56592 to Treat Thrush in HIV-Positive Patients
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: February 2000
History of Changes
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.
Drug : Posaconazole
Drug : Fluconazole
Primary Purpose: Treatment
|Official Title:||Randomized, Controlled Trial of SCH 56592 Oral Suspension Versus Fluconazole Suspension in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
|Study Start Date:||August 1998|
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.Eligibility
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- 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.
You will not be eligible for this study if you:
Contacts and LocationsChoosing 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: NCT00002446
Locations Show More
|United States, California|
|East Bay AIDS Ctr|
|Berkeley, California, United States, 94705|
|San Francisco, California, United States, 94109|
|Kaiser Foundation Hospital|
|San Francisco, California, United States, 94118|
|United States, Colorado|
|Infectious Disease and AIDS Clinic|
|Denver, Colorado, United States, 80204|
|United States, District of Columbia|
|Dupont Circle Physicians Group|
|Washington, District of Columbia, United States, 200091104|
|United States, Florida|
|Boulevard Comprehensive Care Ctr|
|Jacksonville, Florida, United States, 32209|
|Miami Veterans Administration Med Ctr|
|Miami, Florida, United States, 33125|
|United States, Illinois|
|TRIAD Health Practice|
|Chicago, Illinois, United States, 60657|
|United States, Indiana|
|Community Hosp Indianapolis|
|Indianapolis, Indiana, United States, 46219|
|United States, Michigan|
|Wayne State Univ / Harper Hosp|
|Detroit, Michigan, United States, 48201|
|United States, New Jersey|
|UMDNJ - New Jersey Med School / Cooper Hosp|
|Camden, New Jersey, United States, 08103|
|Jersey City Med Ctr|
|Jersey City, New Jersey, United States, 07304|
|United States, New York|
|SUNY / Health Science Ctr at Brooklyn|
|Brooklyn, New York, United States, 11203|
|United States, Pennsylvania|
|Univ of Pennsylvania School of Dental Medicine|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, South Carolina|
|Med Univ of South Carolina|
|Charleston, South Carolina, United States, 29425|
|United States, Texas|
|Amelia Ct Clinic|
|Dallas, Texas, United States, 75235|
|Univ of Texas Health Sciences Ctr|
|San Antonio, Texas, United States, 78284|
|Queen Elizabeth Hosp Respiratory Unit|
|St Michael, Barbados|
Sponsors and CollaboratorsSchering-Plough
|ClinicalTrials.gov Identifier:||NCT00002446 History of Changes|
|Other Study ID Numbers:||305A|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:AIDS-Related Opportunistic Infections
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on February 28, 2020
This information is provided by ClinicalTrials.gov.