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

November 2, 1999
June 23, 2005
August 1998
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Complete list of historical versions of study NCT00002446 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Phase 3
Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
  • Candidiasis, Oral
  • HIV Infections
  • Drug: Posaconazole
  • Drug: Fluconazole
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Barbados
 
NCT00002446
305A, C97-331, I97-331
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Schering-Plough
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NIH AIDS Clinical Trials Information Service
February 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP