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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002431
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1993
  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

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
ClinicalTrials.gov Identifier: NCT00002431     History of Changes
Other Study ID Numbers: 050A, CC-220
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Candidiasis
Candidiasis, Oral
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Mycoses
Mouth Diseases
Stomatognathic Diseases
Chlorhexidine gluconate
Anti-Infective Agents
Chlorhexidine
Anti-Infective Agents, Local
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on July 31, 2014