Safety and Effectiveness of Fluconazole Versus SCH 56592 to Treat Thrush in HIV-Positive Patients
Randomized, Controlled Trial of SCH 56592 Oral Suspension Versus Fluconazole Suspension in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients
3 other identifiers
interventional
300
2 countries
18
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
18 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
Study Start
First participant enrolled
August 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
February 1, 2000
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- You will not be eligible for this study if you:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Schering-Ploughlead
Study Sites (18)
East Bay AIDS Ctr
Berkeley, California, 94705, United States
ViRx Inc
San Francisco, California, 94109, United States
Kaiser Foundation Hospital
San Francisco, California, 94118, United States
Infectious Disease and AIDS Clinic
Denver, Colorado, 80204, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 200091104, United States
Boulevard Comprehensive Care Ctr
Jacksonville, Florida, 32209, United States
Miami Veterans Administration Med Ctr
Miami, Florida, 33125, United States
TRIAD Health Practice
Chicago, Illinois, 60657, United States
Community Hosp Indianapolis
Indianapolis, Indiana, 46219, United States
Wayne State Univ / Harper Hosp
Detroit, Michigan, 48201, United States
UMDNJ - New Jersey Med School / Cooper Hosp
Camden, New Jersey, 08103, United States
Jersey City Med Ctr
Jersey City, New Jersey, 07304, United States
SUNY / Health Science Ctr at Brooklyn
Brooklyn, New York, 11203, United States
Univ of Pennsylvania School of Dental Medicine
Philadelphia, Pennsylvania, 19104, United States
Med Univ of South Carolina
Charleston, South Carolina, 29425, United States
Amelia Ct Clinic
Dallas, Texas, 75235, United States
Univ of Texas Health Sciences Ctr
San Antonio, Texas, 78284, United States
Queen Elizabeth Hosp Respiratory Unit
Saint Michael, Barbados