Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT00002156
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )
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': 'D017088', 'term': 'AIDS-Related Opportunistic Infections'}, {'id': 'D054069', 'term': 'Multiple Acyl Coenzyme A Dehydrogenase Deficiency'}, {'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': 'D009894', 'term': 'Opportunistic Infections'}, {'id': 'D000592', 'term': 'Amino Acid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D028361', 'term': 'Mitochondrial Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C091346', 'term': 'fomivirsen'}, {'id': 'D015774', 'term': 'Ganciclovir'}], 'ancestors': [{'id': 'D000212', 'term': 'Acyclovir'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 194}}, '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': ['AIDS-Related Opportunistic Infections', 'Ganciclovir', 'Drug Therapy, Combination', 'Acquired Immunodeficiency Syndrome', 'Antiviral Agents', 'Cytomegalovirus Retinitis', 'Injections'], 'conditions': ['Cytomegalovirus Retinitis', 'HIV Infections']}, 'descriptionModule': {'briefSummary': 'To determine the clinically safe and effective dose of intravitreal ISIS 2922 alone and as an additive antiviral therapy to ganciclovir in AIDS patients with cytomegalovirus (CMV) retinitis.', 'detailedDescription': 'In Stage 1 of the study, 20 patients receive one of two doses of ISIS 2922 on days 1, 8, and 15 (Induction) then every 14 days (maintenance), with ganciclovir given daily during both Induction and Maintenance. Escalation to the second dose does not occur until all patients at the first dose level have reached their first maintenance dose (day 29). In Stage 2 of the study, 174 patients are randomized to receive either a) ISIS 2922 at the dose established in Stage 1 on days 1, 8, and 15 and then every 14 days, with ganciclovir given daily during both Induction and Maintenance, or b) ganciclovir daily for 14 consecutive days and then a lower dose as maintenance. Patients may continue to receive ISIS 2922 biweekly if the dose is safe and their CMV retinitis is clinically controlled. Per 2/8/96 amendment, patients are now in Stage 2 at 150 mcg.'}, '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 that is not adequately controlled (previously diagnosed patients with smoldering CMV retinitis or those with active CMV retinitis borders on indirect ophthalmoscopy).\n* No more than one previous progression of CMV retinitis.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions in the eye to be treated are excluded:\n\n* External ocular infection.\n* Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other disease of the fundus.\n* Ocular condition that will obstruct visualization of the posterior ocular structures.\n* Retinal detachment.\n* Silicone oil in eye.\n\nPatients with the following other symptoms or conditions are excluded:\n\n* Known or suspected allergy to phosphorothioate oligonucleotides.\n* Syphilis.\n* Retinal pigment epithelial stippling not associated with CMV retinitis.\n* Pseudoretinitis pigmentosa.\n* Chronic diarrhea that would impair absorption of oral ganciclovir.\n* Intolerance to ganciclovir.\n\nConcurrent Medication:\n\nExcluded:\n\n* Foscarnet or other anti-CMV agents other than ganciclovir.\n* Mellaril.\n* Stelazine.\n* Thorazine.\n* Clofazimine.\n* Ethambutol/fluconazole combination.\n* Investigational medications for CMV retinitis.\n\nConcurrent Treatment:\n\nExcluded:\n\n* Investigational procedures 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 intolerance to ISIS 2922.\n\nPrior Medication:\n\nExcluded:\n\n* Prior ganciclovir implant for CMV retinitis.\n* More than 4 months of prior ganciclovir.'}, 'identificationModule': {'nctId': 'NCT00002156', 'briefTitle': 'A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )', 'orgStudyIdInfo': {'id': '251B'}, 'secondaryIdInfos': [{'id': 'ISIS 2922-CS3'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Fomivirsen sodium', 'type': 'DRUG'}, {'name': 'Ganciclovir', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'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': '33060', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Dr Julio Perez', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'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': '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 and Throat Association', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'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': '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'}}}}