Clinical trial NCT00002431: 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
Overall status: COMPLETED
Phase: NA
Conditions: Candidiasis, Oral
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
chlorhexidine gluconate
Acquired Immunodeficiency Syndrome
Anti-Infective Agents, Local
AIDS-Related Complex
Candidiasis, Oral
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 13
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Dental Research Institute / UCLA Med Ctr
state: California
city: San Francisco
country: United States
facility: UCSF / Stomatology Clinical Ctr
state: California
city: Columbus
country: United States
facility: Ohio State Univ Hosp Clinic
state: Ohio
city: Houston
country: United States
facility: Bering Dental Clinic
state: Texas
city: Houston
country: United States
facility: Hermann Hosp / Univ Texas Health Science Ctr
state: Texas
Study officials:
References:
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.