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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Conditions
Age range
13 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Dental Research Institute / UCLA Med Ctr, Los Angeles, California, United States
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
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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