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

This study has been completed.

Sponsored by: Procter and Gamble
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002431
  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.


Condition Intervention
Candidiasis, Oral
HIV Infections
Drug: Chlorhexidine gluconate

MedlinePlus related topics:   AIDS    Yeast Infections   

Drug Information available for:   Chlorhexidine    Chlorhexidine digluconate    D-Gluconic acid, monosodium salt    Gluconic acid    Manganese gluconate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Dose Comparison
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
  Eligibility
Ages Eligible for Study:   13 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002431

Locations
United States, California
Dental Research Institute / UCLA Med Ctr    
      Los Angeles, California, United States, 900951762
UCSF / Stomatology Clinical Ctr    
      San Francisco, California, United States, 94143
United States, Ohio
Ohio State Univ Hosp Clinic    
      Columbus, Ohio, United States, 432101228
United States, Texas
Hermann Hosp / Univ Texas Health Science Ctr    
      Houston, Texas, United States, 77030
Bering Dental Clinic    
      Houston, Texas, United States, 77006

Sponsors and Collaborators
Procter and Gamble
  More Information


Publications:

Study ID Numbers:   050A, CC-220
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002431
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections  
chlorhexidine gluconate  
Acquired Immunodeficiency Syndrome  
Anti-Infective Agents, Local
AIDS-Related Complex
Candidiasis, Oral

Study placed in the following topic categories:
Mouth Diseases
Opportunistic Infections
Sexually Transmitted Diseases, Viral
Candidiasis, Oral
Chlorhexidine
Candidiasis
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Immunologic Deficiency Syndromes
Virus Diseases
Mycoses
HIV Seropositivity
Chlorhexidine gluconate
HIV Infections
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Stomatognathic Diseases
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Infective Agents, Local
Communicable Diseases
Disinfectants
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Therapeutic Uses
Lentivirus Infections
Infection
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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