Expired Study
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Houston, Texas 77006


Purpose:

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.


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.


NCT ID:

NCT00002431


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Houston, Texas 77006
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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