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OpenTrials
Completed

NCT Number: NCT00002431

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

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chlorhexidine gluconate

Drug

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Official study title

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

Important dates

First posted
Aug 31, 2001
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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