Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-28 @ 5:36 PM
Study NCT ID:
NCT00002057
Status:
COMPLETED
Last Update Posted:
2007-10-02
First Post:
1999-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002180', 'term': 'Candidiasis, Oral'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D017088', 'term': 'AIDS-Related Opportunistic Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D000386', 'term': 'AIDS-Related Complex'}], 'ancestors': [{'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009894', 'term': 'Opportunistic Infections'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009761', 'term': 'Nystatin'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'statusVerifiedDate': '2007-10', 'lastUpdateSubmitDate': '2007-10-01', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2007-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Nystatin', 'AIDS-Related Opportunistic Infections', 'Acquired Immunodeficiency Syndrome', 'AIDS-Related Complex', 'Candidiasis, Oral'], 'conditions': ['Candidiasis, Oral', 'HIV Infections']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Systemic or oral antibiotics.\n* Experimental drugs (IND drugs) which are targeted specifically against the AIDS (group IV CDC classification) virus or stimulate the immune system.\n\nPatients with the following conditions are included:\n\n* 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.\n* Able to follow instructions regarding the use of a pastille.\n* 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.\n* Oral lesions such as Kaposi's sarcoma, herpes zoster, and herpes simplex can be enrolled.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\n* Systemic candidiasis.\n* Hypersensitivity to nystatin.\n* Suspected or proven candidal esophagitis.\n\nPatients with the following are excluded:\n\n* Systemic candidiasis.\n* Projected survival of less than 6 months.\n* Unable to maintain a pastille in the buccal cavity for approximately 20 minutes twice a day.\n* Hypersensitivity to nystatin.\n* Suspected or proven candidal esophagitis."}, 'identificationModule': {'nctId': 'NCT00002057', 'briefTitle': 'Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC', 'orgStudyIdInfo': {'id': '026A'}, 'secondaryIdInfos': [{'id': '4'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Nystatin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Birmingham Veterans Administration Med Ctr / Univ of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '085434000', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Bristol - Myers Squibb Co', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}}}}