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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002446
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: February 2000
  Purpose

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 Intervention Phase
Candidiasis, Oral
HIV Infections
Drug: Posaconazole
Drug: Fluconazole
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 300
Study Start Date: August 1998
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing 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
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
Barbados
Queen Elizabeth Hosp Respiratory Unit
St Michael, Barbados
Sponsors and Collaborators
Schering-Plough
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002446     History of Changes
Other Study ID Numbers: 305A, C97-331, I97-331
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
HIV Seropositivity
Candidiasis
Candidiasis, Oral
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Mycoses
Mouth Diseases
Stomatognathic Diseases
Fluconazole
Posaconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on October 16, 2014