Candidiasis, Oral, HIV Infections
Conditions
Keywords
AIDS-Related Opportunistic Infections, chlorhexidine gluconate, Acquired Immunodeficiency Syndrome, Anti-Infective Agents, Local, AIDS-Related Complex, Candidiasis, Oral
Brief 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.
Interventions
DRUGChlorhexidine gluconate
Sponsors
Procter and Gamble
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
13 Years to 75 Years
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed