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

NCT ID: NCT00002431

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

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.

Conditions

Candidiasis, Oral; HIV Infections

Study Design

• Primary Study Purpose: TREATMENT

Interventions

Chlorhexidine gluconate

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: lead

Locations

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

Countries

United States

References

Greenspan D. Treatment of oral candidiasis in HIV infection. Oral Surg Oral Med Oral Pathol. 1994 Aug;78(2):211-5. doi: 10.1016/0030-4220(94)90149-x.

Reference Type: BACKGROUND

PMID: 7936591 (View on PubMed)

Other Identifiers

CC-220

Identifier Type: -

Identifier Source: secondary_id

050A

Identifier Type: -

Identifier Source: org_study_id