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

Completed · Not applicable

Conditions studied: Candidiasis, Oral, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002431

Run by

Procter and Gamble

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Prior Medication:
• Allowed within 6 months of study entry:
• Treatment for oral candidiasis.

You may not qualify if…

• 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.

Where it is running

• Dental Research Institute / UCLA Med Ctr — Los Angeles, California, United States
• UCSF / Stomatology Clinical Ctr — San Francisco, California, United States
• Ohio State Univ Hosp Clinic — Columbus, Ohio, United States
• Bering Dental Clinic — Houston, Texas, United States
• Hermann Hosp / Univ Texas Health Science Ctr — Houston, Texas, United States

Full record on ClinicalTrials.gov

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