Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Chlorhexidine gluconate

Drug
Who is being recruted

Blood-Borne Infections+22

+ Urogenital Diseases

+ Genital Diseases

From 13 to 75 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorProcter and Gamble
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

NCT00002431
Principal SponsorProcter and Gamble
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 13 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesBacterial Infections and MycosesCandidiasisCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsStomatognathic DiseasesMouth DiseasesMycosesOpportunistic InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexCandidiasis, OralHIV InfectionsAIDS-Related Opportunistic Infections

Criteria

5 inclusion criteria required to participate
Allowed within 6 months of study entry: Treatment for oral candidiasis
Patients must be HIV positive
Patients must be willing to complete a medical history
Patients must be willing to sign informed consent
Show More Criteria
12 exclusion criteria prevent from participating
Allergies to chlorhexidine
Anterior composite/acrylic restorations with poor marginal adaption
Antibiotics within 7 days of study entry
Complete dentures, full partial dentures, removable dentures which fit poorly, or any prosthetic appliances which cannot be cleaned with sodium hypochlorite
Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Dental Research Institute / UCLA Med Ctr

Los Angeles, United StatesOpen Dental Research Institute / UCLA Med Ctr in Google Maps

UCSF / Stomatology Clinical Ctr

San Francisco, United States

Ohio State Univ Hosp Clinic

Columbus, United States

Bering Dental Clinic

Houston, United States
Completed5 Study Centers