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Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC



Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC

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 prevention of oral candidiasis in patients with AIDS or AIDS related complex (ARC) (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: - Systemic or oral antibiotics. - Experimental drugs (IND drugs) which are targeted specifically against the AIDS (group IV CDC classification) virus or stimulate the immune system. Patients with the following conditions are included: - AIDS or AIDS related complex (ARC) (HIV infection Group 3 or 4, CDC classification) who have had culture-proven oral candidiasis clinically cured within 7 days of study entry and are likely to be compliant for the 20 weeks of nystatin pastille prophylaxis. - Able to follow instructions regarding the use of a pastille. - Patients entering part II of this study (randomized double-blind) must have been clinically cured of oral candidiasis within 1 - 7 days of entry into this randomized study. - Oral lesions such as Kaposi's sarcoma, herpes zoster, and herpes simplex can be enrolled. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - Systemic candidiasis. - Hypersensitivity to nystatin. - Suspected or proven candidal esophagitis. Patients with the following are excluded: - Systemic candidiasis. - Projected survival of less than 6 months. - Unable to maintain a pastille in the buccal cavity for approximately 20 minutes twice a day. - Hypersensitivity to nystatin. - Suspected or proven candidal esophagitis.
Total Enrollment: 

Location and Contact Information:

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

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


Additional Information:
Study ID Numbers:  026A;  4
Study Start Date: 
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002057

Other Hiv Infections Studies:
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2. Safety and Effectiveness of Fluconazole Versus SCH 56592 to Treat Thrush in HIV-Positive Patients

3. The Effect of Oral Candidiasis on the Speech Production, Feeding Skills, and Self-Concept of Children and Adolescents with Symptomatic HIV Infection

4. A Comparison of the Safety and Effectiveness of Fluconazole or Clotrimazole in the Treatment of Fungal Infections of the Mouth and Throat in Patients with AIDS

5. Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome

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