The Safety and Effectiveness of Peridex in Preventing or Delaying Fungal Infections of the Mouth in HIV-Infected Patients

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002431
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1993

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002431 on ClinicalTrials.gov Archive Site
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The Safety and Effectiveness of Peridex in Preventing or Delaying Fungal Infections of the Mouth in HIV-Infected Patients
A Multi-Center Trial to Evaluate the Safety and Effectiveness of Peridex Dosed Twice or Three Times Daily for Preventing or Delaying the Occurrence of Lesions Due to Oral Candidiasis in HIV-Positive Individuals

To evaluate the safety and effectiveness of Peridex (an oral rinse containing chlorhexidine gluconate) for preventing the occurrence of clinically-evident microbiologically-documented oral candidiasis in HIV-positive patients, who are at risk of the disease based on previous history of candidiasis.

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Interventional
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Primary Purpose: Treatment
  • Candidiasis, Oral
  • HIV Infections
Drug: Chlorhexidine gluconate
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Greenspan D. Treatment of oral candidiasis in HIV infection. Oral Surg Oral Med Oral Pathol. 1994 Aug;78(2):211-5. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria

Prior Medication:

Allowed within 6 months of study entry:

  • Treatment for oral candidiasis.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Either history of esophageal candidiasis or current mucocutaneous candidiasis (angular cheilitis).
  • Allergies to chlorhexidine.
  • Gross periodontal neglect or need for periodontal treatment within the past two weeks.

Concurrent Medication:

Excluded:

  • Systemic or oral topical mucocutaneous antifungal therapy.
  • Systemic or oral topical corticosteroids.
  • Antibiotics.
  • Mouth rinses other than the study drug.

Concurrent Treatment:

Excluded:

  • Dental prophylaxis.

Patients with the following are excluded:

  • Complete dentures, full partial dentures, removable dentures which fit poorly, or any prosthetic appliances which cannot be cleaned with sodium hypochlorite.
  • Allergies to chlorhexidine.
  • Sensitivity/intolerance to alcohol.
  • Anterior composite/acrylic restorations with poor marginal adaption.
  • Gross periodontal neglect or periodontal treatment within the past two weeks.
  • Inability to comply with the study protocol based on the investigator's discretion.

Prior Medication:

Excluded within 7 days of study entry:

  • Systemic or oral topical mucocutaneous antifungal therapy.
  • Antibiotics.
  • Daily use of mouth rinses.
  • Excluded within 1 month of study entry:
  • Systemic or oral topical corticosteroids.

Prior Treatment:

Excluded within 2 weeks of starting study drug:

  • Dental prophylaxis or periodontal treatment.

Patients must be:

  • HIV positive.
  • Previously experienced at least one episode of clinically diagnosed oral candidiasis but currently free of clinical signs of oral candidiasis.
  • Willing to sign informed consent.
  • Willing to complete a medical history.
Both
13 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002431
050A, CC-220
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Procter and Gamble
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NIH AIDS Clinical Trials Information Service
November 1993

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