Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC
Nystatin
Infections transmises par le sang+22
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
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).
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 12 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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.
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 2 sites
Birmingham Veterans Administration Med Ctr / Univ of Alabama
Birmingham, United StatesOuvrir Birmingham Veterans Administration Med Ctr / Univ of Alabama dans Google MapsBristol - Myers Squibb Co
Princeton, United States