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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002399
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: January 1999
  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: Endpoint Classification: Safety Study
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002399

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

No publications provided

ClinicalTrials.gov Identifier: NCT00002399     History of Changes
Other Study ID Numbers: 288A, C96-209, I96-209
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
Antifungal Agents
Candidiasis
Triazoles

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Candidiasis
Candidiasis, Oral
HIV Seropositivity
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 April 15, 2014