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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002431
• Other study ID #: 050A
• Secondary ID: CC-220
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: November 1993
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 75 Years

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Oral
• HIV Infections
• Infection

Intervention

Drug:
• Chlorhexidine gluconate

Locations

Country	Name	City	State
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	Dental Research Institute / UCLA Med Ctr	Los Angeles	California
United States	UCSF / Stomatology Clinical Ctr	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Country where clinical trial is conducted

United States, 

References & Publications (1)

Greenspan D. Treatment of oral candidiasis in HIV infection. Oral Surg Oral Med Oral Pathol. 1994 Aug;78(2):211-5. Review. — View Citation