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

Primary Purpose

Candidiasis, Oral, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine gluconate
Sponsored by
Procter and Gamble
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Candidiasis, Oral focused on measuring AIDS-Related Opportunistic Infections, chlorhexidine gluconate, Acquired Immunodeficiency Syndrome, Anti-Infective Agents, Local, AIDS-Related Complex, Candidiasis, Oral

Eligibility Criteria

13 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dental Research Institute / UCLA Med Ctr
  • UCSF / Stomatology Clinical Ctr
  • Ohio State Univ Hosp Clinic
  • Bering Dental Clinic
  • Hermann Hosp / Univ Texas Health Science Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Procter and Gamble
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1. Study Identification

Unique Protocol Identification Number
NCT00002431
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 1993
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Procter and Gamble

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Oral, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, chlorhexidine gluconate, Acquired Immunodeficiency Syndrome, Anti-Infective Agents, Local, AIDS-Related Complex, Candidiasis, Oral

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Dental Research Institute / UCLA Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
900951762
Country
United States
Facility Name
UCSF / Stomatology Clinical Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Ohio State Univ Hosp Clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432101228
Country
United States
Facility Name
Bering Dental Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77006
Country
United States
Facility Name
Hermann Hosp / Univ Texas Health Science Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7936591
Citation
Greenspan D. Treatment of oral candidiasis in HIV infection. Oral Surg Oral Med Oral Pathol. 1994 Aug;78(2):211-5. doi: 10.1016/0030-4220(94)90149-x.
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The Safety and Effectiveness of Peridex in Preventing or Delaying Fungal Infections of the Mouth in HIV-Infected Patients

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