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The Safety and Effectiveness of Peridex in Preventing or Delaying Fungal Infections of the Mouth in HIV-Infected Patients Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about The Safety and Effectiveness of Peridex in Preventing or Delaying Fungal Infections of the Mouth in HIV-Infected Patients conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. The Safety and Effectiveness of Peridex in Preventing or Delaying Fungal Infections of the Mouth in HIV-Infected Patients Clinical research trials and The Safety and Effectiveness of Peridex in Preventing or Delaying Fungal Infections of the Mouth in HIV-Infected Patients healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as The Safety and Effectiveness of Peridex in Preventing or Delaying Fungal Infections of the Mouth in HIV-Infected Patients. The Safety and Effectiveness of Peridex in Preventing or Delaying Fungal Infections of the Mouth in HIV-Infected Patients Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a The Safety and Effectiveness of Peridex in Preventing or Delaying Fungal Infections of the Mouth in HIV-Infected Patients clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their The Safety and Effectiveness of Peridex in Preventing or Delaying Fungal Infections of the Mouth in HIV-Infected Patients condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.

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The Safety and Effectiveness of Peridex in Preventing or Delaying Fungal Infections of the Mouth in HIV-Infected Patients



The Safety and Effectiveness of Peridex in Preventing or Delaying Fungal Infections of the Mouth in HIV-Infected Patients

For Condition: Candidiasis, Oral,HIV Infections
Status: Completed
Sponsor(s): Procter & Gamble Pharmaceuticals ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Dose Comparison
Minimum Age/Maximum Age: 13 Years/75 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

Ohio State Univ Hosp Clinic
Columbus,  Ohio,  432101228
United States
 

Bering Dental Clinic
Houston,  Texas,  77006
United States
 

Dental Research Institute / UCLA Med Ctr
Los Angeles,  California,  900951762
United States
 

UCSF / Stomatology Clinical Ctr
San Francisco,  California,  94143
United States
 

Hermann Hosp / Univ Texas Health Science Ctr
Houston,  Texas,  77030
United States
 


Additional Information:
Study ID Numbers:
  050A;  CC-220
Study Start Date: 
Record last reviewed: November 1993
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002431

Other Candidiasis, Oral Studies:
1. A Study of ddI in Children with AIDS Who Have Not Had Success with Zidovudine

2. A Study of Saquinavir Soft Gelatin Capsules Plus Zidovudine Plus Lamivudine in the Treatment of HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs

3. A Phase I Study of the Safety and Immunogenicity of rgp120/HIV-1IIIB Vaccine in Healthy Adult Subjects (NOTE: Study extended ONLY for subjects who have previously received rgp120/HIV-1IIIB or rgp120/HIV-1MN on VEU 006 or VEU 006 Rollover study)

4. Effectiveness of Adding Interleukin-2 to Anti-HIV Drugs in Patients Recently Infected with HIV

5. A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral / Oral Trimethoprim - Sulfamethoxazole in the Treatment of Pneumocystis carinii Pneumonia in AIDS

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