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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002431 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	The Safety and Effectiveness of Peridex in Preventing or Delaying Fungal Infections of the Mouth in HIV-Infected Patients
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Dose Comparison
Condition ^ICMJE	Candidiasis, Oral HIV Infections
Intervention ^ICMJE	Drug: Chlorhexidine gluconate
Study Arms / Comparison Groups
Publications *	Greenspan D. Treatment of oral candidiasis in HIV infection. Oral Surg Oral Med Oral Pathol. 1994 Aug;78(2):211-5. Review.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002431
Responsible Party
Study ID Numbers ^ICMJE	050A, CC-220
Study Sponsor ^ICMJE	Procter and Gamble
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	November 1993
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP