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A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002399
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
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.
Information provided by:
NIH AIDS Clinical Trials Information Service
  Purpose
The purpose of this study is to compare the safety and effectiveness of SCH 56592 with that of fluconazole in the treatment of OPC (a fungal infection of the throat) in HIV-positive patients.

Condition Intervention Phase
Candidiasis, Oral HIV Infections Drug: Posaconazole Drug: Fluconazole Phase 2

Study Type: Interventional
Study Design: Masking: Double
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Phase II Study to Evaluate the Safety, Tolerance and Efficacy of Multiple Doses of SCH 56592 Versus Fluconazole 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: 500
Detailed Description:
This is a randomized, multicenter, double-blind study consisting of 5 arms (4 dose levels of SCH 56592 vs fluconazole) in the treatment of oropharyngeal candidiasis (OPC) in HIV-positive patients.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients must have:

  • Documented HIV seropositivity (by Western blot or other approved confirmatory test) prior to enrollment.
  • Pseudomembranous oropharyngeal candidiasis.
  • Fungal stain or KOH consistent with Candida species, confirmed by a positive mycologic culture.
  • Ability to swallow study medication.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms and conditions are excluded:

  • Medical condition requiring use of prohibited drugs.
  • Primary HIV seroconversion-related mucosal candidiasis.
  • Systemic candidiasis.
  • All forms of OPC other than pseudomembranous (unless accompanied by pseudomembranous OPC).
  • Documented or suspected fungal esophagitis in patients with symptoms of esophagitis.
  • EKG with prolonged QTc interval or clinically-significant abnormalities.

Concurrent Medication:

Excluded:

  • Systemic antifungals (IV or oral).
  • Topical oral antifungals, e.g., Nystatin, Mycelex, etc.
  • Medications known to interact with azoles and that may lead to life-threatening side effects:
  • terfenadine, astemizole, cisapride, ebastine, triazolam, midazolam.
  • Medications known to lower the serum concentration/efficacy of azole antifungals:
  • rifampin, carbamazepine, phenytoin, rifabutin, barbiturates, isoniazid, H2 blockers.
  • Cytokines (except erythropoietin), interferon, or lymphocyte replacement therapy unless patient already taking these agents for at least 30 days prior to enrollment.
  • Protease inhibitors, starting for the first time, 30 days prior to study enrollment.
  • Cytotoxic therapy for cancer.
  • Oral or intravenous corticosteroids at supraphysiologic doses (prednisone 10 mg/day or greater; hydrocortisone 40 mg/day or greater; dexamethasone 2 mg/day or greater.

Patients with any of the following prior conditions are excluded:

  • Prior enrollment in this study.
  • Less than 3 months life expectancy.
  • History of hypersensitivity to azole antifungals.
  • History of failed therapy with fluconazole 100 mg/day for 2 weeks in the last 3 months.

Prior Medication:

Excluded (wash-outs for medications):

  • Systemic antifungals (IV, oral) within 14 days prior to enrollment.
  • Topical oral antifungals within 1 day prior to enrollment.
  • Oral or intravenous corticosteroids at supraphysiologic doses within 10 days prior to enrollment.
  • Astemizole within 10 days prior to enrollment.
  • Drugs known to lower the serum concentration/efficacy of azole antifungals within 30 days prior to enrollment.
  • Investigational drug (unlicensed new chemical entity) use within 30 days prior to enrollment.

Current known drug abuse, in the opinion of the lead investigator, that would interfere with the subject's participation in the study.

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00002399


  Show 53 Study Locations
Sponsors and Collaborators
Schering-Plough
  More Information

ClinicalTrials.gov Identifier: NCT00002399     History of Changes
Other Study ID Numbers: 288A
C96-209
I96-209
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: January 1999

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Fluconazole
Antifungal Agents
Candidiasis
Triazoles

Additional relevant MeSH terms:
HIV Infections
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
Mycoses
Mouth Diseases
Stomatognathic Diseases
Fluconazole
Posaconazole
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