ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
The Safety and Effectiveness of Peridex in Preventing or Delaying Fungal Infections of the Mouth in HIV-Infected Patients

This study has been completed.
Study NCT00002431.   Last updated on June 23, 2005.   Information provided by NIH AIDS Clinical Trials Information Service

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
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
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.

Detailed Description
Study Phase
Study Type  Interventional
Study Design  Treatment, Dose Comparison
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Candidiasis, Oral
HIV Infections
Intervention  Drug: Chlorhexidine gluconate
MEDLINE PMIDs 7936591
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date 
Completion Date
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.
Gender Both
Ages 13 Years to 75 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00002431
Organization ID 050A
Secondary IDs †† CC-220
Study Sponsor  Procter and Gamble
Collaborators ††
Investigators 
Information Provided By NIH AIDS Clinical Trials Information Service
Verification Date November 1993
First Received Date  November 2, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers