- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002431
The Safety and Effectiveness of Peridex in Preventing or Delaying Fungal Infections of the Mouth in HIV-Infected Patients
June 23, 2005 updated by: Procter and Gamble
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 900951762
- Dental Research Institute / UCLA Med Ctr
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San Francisco, California, United States, 94143
- UCSF / Stomatology Clinical Ctr
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Ohio
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Columbus, Ohio, United States, 432101228
- Ohio State Univ Hosp Clinic
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Texas
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Houston, Texas, United States, 77030
- Hermann Hosp / Univ Texas Health Science Ctr
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Houston, Texas, United States, 77006
- Bering Dental Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 73 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
November 1, 1993
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 050A
- CC-220
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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