NCT00002431

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

November 1, 1993

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Candidiasis, OralHIV Infections

Keywords

AIDS-Related Opportunistic Infectionschlorhexidine gluconateAcquired Immunodeficiency SyndromeAnti-Infective Agents, LocalAIDS-Related ComplexCandidiasis, Oral

Interventions

Chlorhexidine gluconateDRUG

Eligibility Criteria

Age13 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Prior Medication:
  • Allowed within 6 months of study entry:
  • Treatment for oral candidiasis.

You may not qualify if:

  • 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:
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Dental Research Institute / UCLA Med Ctr

Los Angeles, California, 900951762, United States

Location

UCSF / Stomatology Clinical Ctr

San Francisco, California, 94143, United States

Location

Ohio State Univ Hosp Clinic

Columbus, Ohio, 432101228, United States

Location

Bering Dental Clinic

Houston, Texas, 77006, United States

Location

Hermann Hosp / Univ Texas Health Science Ctr

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 7936591BACKGROUND

MeSH Terms

Conditions

Candidiasis, OralHIV InfectionsAIDS-Related Opportunistic InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

chlorhexidine gluconate

Condition Hierarchy (Ancestors)

CandidiasisMycosesBacterial Infections and MycosesInfectionsMouth DiseasesStomatognathic DiseasesBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesOpportunistic InfectionsSlow Virus Diseases

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1993-11

Locations

US(5)