Completed

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

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What is being tested

Nystatin

Drug
Who is being recruted

Blood-Borne Infections+22

+ Urogenital Diseases

+ Genital Diseases

Over 12 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorBristol-Myers Squibb
Last updated: October 2, 2007
Sourced from a government-validated database.Claim as a partner

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).

Principal SponsorBristol-Myers Squibb
Last updated: October 2, 2007
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesBacterial Infections and MycosesCandidiasisCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsStomatognathic DiseasesMouth DiseasesMycosesOpportunistic InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexCandidiasis, OralHIV InfectionsAIDS-Related Opportunistic Infections

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Birmingham Veterans Administration Med Ctr / Univ of Alabama

Birmingham, United StatesOpen Birmingham Veterans Administration Med Ctr / Univ of Alabama in Google Maps

Bristol - Myers Squibb Co

Princeton, United States
Completed2 Study Centers