Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:24 PM
Study NCT ID:
NCT00002356
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Safety and Effectiveness of ISIS 2922 in Patients With AIDS Who Have Cytomegalovirus (CMV) of the Eyes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017726', 'term': 'Cytomegalovirus Retinitis'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015828', 'term': 'Eye Infections, Viral'}, {'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003586', 'term': 'Cytomegalovirus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012173', 'term': 'Retinitis'}, {'id': 'D012164', 'term': 'Retinal 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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C091346', 'term': 'fomivirsen'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1998-12', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Acquired Immunodeficiency Syndrome', 'Antiviral Agents', 'Cytomegalovirus Retinitis'], 'conditions': ['Cytomegalovirus Retinitis', 'HIV Infections']}, 'descriptionModule': {'briefSummary': "To evaluate the efficacy and safety of ISIS 2922 in AIDS patients with Cytomegalovirus ( CMV ) retinitis who are unresponsive or intolerant to ganciclovir and/or foscarnet but are otherwise ineligible for ISIS Pharmaceuticals' controlled trials OR who have failed ISIS 2922 therapy on another controlled clinical trial.\n\nPER 2/8/96 AMENDMENT: Patients must rollover from another ISIS 2922 controlled trial.", 'detailedDescription': 'Patients receive intravitreal injections of ISIS 2922 at doses of either 150 or 300 mcg, depending on CMV retinitis location and extent of retinal involvement. There is a 3-week Induction period followed by at least 18 weeks of Maintenance. Induction is given on days 1, 8, and 15, and Maintenance doses are given every 14 days, beginning on day 29.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPatients must have:\n\n* AIDS.\n* CMV retinitis in one or both eyes that was previously treated but is presently uncontrolled.\n* Intolerance or resistance to other therapies.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Eligibility to participate in a controlled clinical trial of ISIS 2922.\n* External ocular infection in eye to be treated.\n* Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other diseases of the fundus in eye to be treated.\n* Ocular condition that would obstruct visualization of the posterior ocular structures in eye to be treated.\n* Retinal detachment in eye to be treated.\n* Known or suspected allergy to phosphorothioate oligonucleotides.\n* Silicone oil in eye to be treated.\n* Syphilis.\n* Clinical evidence of retinal pigment epithelial stippling.\n* Pseudoretinitis pigmentosa.\n\nConcurrent Medication:\n\nExcluded:\n\n* Foscarnet.\n* Mellaril, Stelazine, Thorazine, and Clofazimine.\n* Ethambutol / fluconazole combination.\n* Other investigational drugs for CMV retinitis.\n\nPatients with the following prior conditions are excluded:\n\n* History of surgery to correct retinal detachment in eye to be treated.\n* History of ganciclovir implant for treatment of CMV retinitis.\n* History of intolerance to ISIS 2922.\n* History of syphilis.\n\nRequired:\n\n* Prior CMV retinitis therapy with ganciclovir, foscarnet, or ISIS 2922.'}, 'identificationModule': {'nctId': 'NCT00002356', 'briefTitle': 'The Safety and Effectiveness of ISIS 2922 in Patients With AIDS Who Have Cytomegalovirus (CMV) of the Eyes', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'An Open-Label Study of the Safety and Efficacy of Intravitreal ISIS 2922 in Acquired Immune Deficiency Syndrome (AIDS) Patients With Cytomegalovirus Retinitis (NOTE: Restricted to Patients Who Rollover From Another Controlled ISIS 2922 Trial)', 'orgStudyIdInfo': {'id': '251C'}, 'secondaryIdInfos': [{'id': 'ISIS 2922-CS7'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Fomivirsen sodium', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92715', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'UCI College of Medicine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Retina - Vitreous Associates Med Group', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '911052536', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Community Eye Med Group', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '92134', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Naval Hosp', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Univ of California San Francisco / SF Gen Hosp', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '95128', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Santa Clara Valley Med Ctr', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '80262', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Univ of Colorado Health Sciences Ctr', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '20036', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Dr Alan Palestine', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33060', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Dr Julio Perez', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Bascon Palmer Eye Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Univ School of Medicine / Emory Eye Ctr', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30327', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Retina', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Univ of Illinois', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Univ Med Ctr', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane Univ', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '10028', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Vitreo - Retinal Consultants', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Charlotte Eye Ear Nose & Throat Association', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Univ', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '19102', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hahnemann Univ Hosp', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '191461192', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Graduate Hosp', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '752359057', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ of Texas Southwestern Med Ctr of Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Vitreoretinal Consultants', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Eye Consultants', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Novum Inc', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ionis Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}}}}