Candidiasis, OralNCT00002431
The Safety and Effectiveness of Peridex in Preventing or Delaying Fungal Infections of the Mouth in HIV-Infected Patients
A study testing Chlorhexidine gluconate in people with Candidiasis, Oral and HIV Infections, run by Procter and Gamble at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 75 years
- Conditions the study is for
- Candidiasis, Oral, HIV Infections
- What is being tested?
- Chlorhexidine gluconate
- How many people
- Not given
- Where
- 5 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Prior Medication:
- Allowed within 6 months of study entry:
- Treatment for oral candidiasis.
Who cannot join
- 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:
Show all 36Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
Bering Dental Clinic
Houston, Texas, 77006
Hermann Hosp / Univ Texas Health Science Ctr
Houston, Texas, 77030
Dental Research Institute / UCLA Med Ctr
Los Angeles, California, 900951762
UCSF / Stomatology Clinical Ctr
San Francisco, California, 94143
About this study
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
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.
- Conditions
- Candidiasis, Oral, HIV Infections
- Being tested
- Chlorhexidine gluconate
- Keywords
- AIDS-Related Opportunistic Infections, chlorhexidine gluconate, Acquired Immunodeficiency Syndrome, Anti-Infective Agents, Local, AIDS-Related Complex, Candidiasis, Oral
- Medical subject headings
- Candidiasis, Oral, HIV Infections, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine gluconateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Candidiasis, OralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002431
- Sponsor's protocol ID
- 050A
- Other IDs
- CC-220
- Status last verified
- Nov 1993
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
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.
PubMed 7936591
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00002431
- Acronym / sponsor ID
- 050A
- Conditions
- Candidiasis, Oral, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, chlorhexidine gluconate, Acquired Immunodeficiency Syndrome, Anti-Infective Agents, Local, AIDS-Related Complex, Candidiasis, Oral
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Treatment for oral candidiasis.
Key exclusion criteria (36 listed)
- 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.
- Systemic or oral topical mucocutaneous antifungal therapy.
- Systemic or oral topical corticosteroids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine gluconate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 7936591Greenspan 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine gluconate in people with Candidiasis, Oral and HIV Infections, run by Procter and Gamble at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002431, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.