Expired Study
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Columbus, Ohio 43210


Purpose:

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.


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.


Study is Available At:


Original ID:

050A


NCT ID:

NCT00002431


Secondary ID:

CC-220


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

13 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NIH AIDS Clinical Trials Information Service


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Study Dates

Verification Date:November 1993
Last Changed Date:June 23, 2005
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Chlorhexidine gluconate

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Procter and Gamble

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Greenspan D. Treatment of oral candidiasis in HIV infection. Oral Surg Oral Med Oral Pathol. 1994 Aug;78(2):211-5. Review.
PMID:7936591

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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