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

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-Center Trial to Evaluate the Safety and Effectiveness of Peridex Dosed Twice or Three Times Daily for Preventing or Delaying the Occurrence of Lesions Due to Oral Candidiasis in HIV-Positive Individuals

Conditions
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Candidiasis, Oral, HIV Infections

Intervention / Treatment
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* Drug: Chlorhexidine gluconate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Chlorhexidine gluconate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AIDS-Related Opportunistic Infections, chlorhexidine gluconate, Acquired Immunodeficiency Syndrome, Anti-Infective Agents, Local, AIDS-Related Complex, Candidiasis, Oral