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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 2, 1999 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00002431 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | The Safety and Effectiveness of Peridex in Preventing or Delaying Fungal Infections of the Mouth in HIV-Infected Patients |
| Official Title ICMJE | 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 |
| 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. |
| Detailed Description | |
| Study Phase | |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Dose Comparison |
| Condition ICMJE |
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| Intervention ICMJE | Drug: Chlorhexidine gluconate |
| Study Arms / Comparison Groups | |
| Publications * | Greenspan D. Treatment of oral candidiasis in HIV infection. Oral Surg Oral Med Oral Pathol. 1994 Aug;78(2):211-5. Review. |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria Prior Medication: Allowed within 6 months of study entry:
Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded:
Concurrent Medication: Excluded:
Concurrent Treatment: Excluded:
Patients with the following are excluded:
Prior Medication: Excluded within 7 days of study entry:
Prior Treatment: Excluded within 2 weeks of starting study drug:
Patients must be:
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| Gender | Both |
| Ages | 13 Years to 75 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00002431 |
| Responsible Party | |
| Study ID Numbers ICMJE | 050A, CC-220 |
| Study Sponsor ICMJE | Procter and Gamble |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | November 1993 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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