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

Procter & Gamble (P&G)

Status: Completed

Conditions: HIV Infections; Candidiasis, Oral

Treatments: Drug: Chlorhexidine gluconate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002431

CC-220

050A

Details and patient eligibility

About

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.

Sex: All

Ages: 13 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.