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A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients with AIDS or AIDS-Related Syndromes



A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients with AIDS or AIDS-Related Syndromes

For Condition: Candidiasis, Oral,HIV Infections
Status: No longer recruiting
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: To determine a safe, effective, and convenient dosing schedule for nystatin pastilles in the prophylaxis of oral candidiasis in patients with AIDS or AIDS related syndromes (group III or IV, CDC classification)
Details:
Eligibility:
Study Type:  Interventional, Treatment, Dose Comparison
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Experimental drugs (IND drugs) which are targeted specifically against the AIDS virus or which stimulate the immune system. - Systemic or oral antibiotics. Patients must have AIDS or AIDS-related syndromes (HIV infection: - Group III or IV, CDC classification) and not have been treated for oral candidiasis during the past year. - Patients can be entered into the study who have: - Other oral lesions due to Kaposi's sarcoma, herpes zoster, and herpes simplex. - A positive or negative oral culture for Candida. - Must be able to follow instructions regarding the use of a pastille. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - Oral lesions diagnostic of oral candidiasis or systemic candidiasis. - Suspected or proven candidal esophagitis. Patients with the following are excluded: - Oral lesions diagnostic of oral candidiasis or systemic candidiasis. - Receiving any effective antifungal agent orally or intravenously within 72 hours of study entry. - Not expected to survive for at least 6 months. - Unable to voluntarily maintain a pastille in the buccal cavity for approximately 20 minutes twice a day. - Known hypersensitivity to nystatin. - Suspected or proven candidal esophagitis. Prior Medication: Excluded within 72 hours of study entry: - Any oral or intravenous antifungal agent.
Total Enrollment: 

Location and Contact Information:

Bristol - Myers Squibb Co
Princeton,  New Jersey,  085434000
United States
 

Birmingham Veterans Administration Med Ctr / Univ of Alabama
Birmingham,  Alabama,  35233
United States
 


Additional Information:
Study ID Numbers:  026B;  5
Study Start Date: 
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002293

Other Hiv Infections Studies:
1. The Effect of Oral Candidiasis on the Speech Production, Feeding Skills, and Self-Concept of Children and Adolescents with Symptomatic HIV Infection

2. A Study of Treatments for Fungal Infections of the Mouth and Throat in HIV-Infected Patients Who Have Had Success with Itraconazole But Not with Fluconazole

3. Oral Manifestations of Human Immunodeficiency Virus Infection in High Risk Groups

4. A Study of Amphotericin B in the Treatment of Fungal Infections of the Mouth in HIV-Infected Patients Who Have Not Had Success with Fluconazole

5. A Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Impact of Nystatin on the Development of Oral Irritation in Patients Receiving High Dose Intravenous Interleukin-2

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