Overview
The Safety and Effectiveness of Peridex in Preventing or Delaying Fungal Infections of the Mouth in HIV-Infected Patients
Status:
Completed
Completed
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Procter and GambleTreatments:
Chlorhexidine
Chlorhexidine gluconate
Criteria
Inclusion CriteriaPrior 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.