Safety and Effectiveness of Fluconazole Versus SCH 56592 to Treat Thrush in HIV-Positive Patients
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Candidiasis, Oral; HIV Infections
Intervention: Posaconazole (Drug); Fluconazole (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Schering-Plough
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.
Clinical Details
Official title: Randomized, Controlled Trial of SCH 56592 Oral Suspension Versus Fluconazole Suspension in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients
Study design: Treatment, Double-Blind, Safety Study
Detailed description:
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
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.
Exclusion Criteria
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.
Locations and Contacts
Queen Elizabeth Hosp Respiratory Unit, St Michael, Barbados
ViRx Inc, San Francisco, California 94109, United States
Kaiser Foundation Hospital, San Francisco, California 94118, United States
East Bay AIDS Ctr, Berkeley, California 94705, United States
Infectious Disease and AIDS Clinic, Denver, Colorado 80204, United States
Dupont Circle Physicians Group, Washington, District of Columbia 200091104, United States
Miami Veterans Administration Med Ctr, Miami, Florida 33125, United States
Boulevard Comprehensive Care Ctr, Jacksonville, Florida 32209, 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
Univ of Texas Health Sciences Ctr, San Antonio, Texas 78284, United States
Amelia Ct Clinic, Dallas, Texas 75235, United States
Additional Information
Starting date: August 1998
Last updated: June 23, 2005
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