Safety and Effectiveness of Fluconazole Versus SCH 56592 to Treat Thrush in HIV-Positive Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002446
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

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.

Condition or disease Intervention/treatment Phase
Candidiasis, Oral HIV Infections Drug: Posaconazole Drug: Fluconazole Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Masking: Double
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
Study Start Date : August 1998

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002446

United States, California
East Bay AIDS Ctr
Berkeley, California, United States, 94705
ViRx Inc
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 Collaborators
Schering-Plough Identifier: NCT00002446     History of Changes
Other Study ID Numbers: 305A
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: February 2000

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Administration, Oral
Antifungal Agents
Candidiasis, Oral
Pharyngeal Diseases

Additional relevant MeSH terms:
HIV Infections
Candidiasis, Oral
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Mouth Diseases
Stomatognathic Diseases
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Trypanocidal Agents
Antiprotozoal Agents