Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-28 @ 7:56 PM
Study NCT ID:
NCT00002257
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment With Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People With AIDS
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': 'D012173', 'term': 'Retinitis'}, {'id': 'D054069', 'term': 'Multiple Acyl Coenzyme A Dehydrogenase Deficiency'}, {'id': 'D003586', 'term': 'Cytomegalovirus Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015828', 'term': 'Eye Infections, Viral'}, {'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'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': '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': '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1992-07', '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': ['Retinitis', 'Ganciclovir', 'Cytomegalovirus Infections', 'Acquired Immunodeficiency Syndrome'], 'conditions': ['Cytomegalovirus Retinitis', 'HIV Infections']}, 'descriptionModule': {'briefSummary': 'To compare the time to progression of CMV retinitis between oral ganciclovir and IV ganciclovir during 20 weeks of maintenance treatment. To compare the safety and tolerance of oral ganciclovir with IV ganciclovir therapy during 20 weeks of maintenance treatment. To describe the safety and tolerance of oral ganciclovir treatment when given concurrently with anti-retroviral treatment, e.g. zidovudine or ddI. To describe the survival of people with AIDS and CMV retinitis.', 'detailedDescription': 'Approximately 150 subjects with AIDS and newly diagnosed CMV retinitis will be enrolled in the study to achieve 120 randomized subjects. Eligible subjects will have CMV retinitis which has been diagnosed within one month of study entry by an ophthalmologist using indirect ophthalmoscopy. Subjects will be accrued by recruitment or referral. Anyone who volunteers for the study, meets the eligibility criteria, and signs an informed consent will be eligible for entry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPatients must have the following:\n\n* Confirmation of HIV infection by HIV-antibody testing, p24 antigen assay, or culture of HIV, or have diagnosis of AIDS by CDC criteria.\n* CMV retinitis diagnosed within one month of study entry.\n* Understand the nature of the study, agree to its provisions, and sign the informed consent approved by the appropriate institutional review board and Syntex.\n\nExclusion Criteria\n\nConcurrent Medication:\n\nThe following are excluded:\n\n* Antimetabolites. Alkylating agents. Selected nucleoside analogs. Selected Cytokines.\n\nPatients with the following are excluded:\n\n* Persistent diarrhea, nausea, or abdominal pain or other clinically significant GI symptoms or uncontrolled gastrointestinal disease. Diarrhea is defined as 3 or more unformed stools per day.\n* Have ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic retinal assessment and photography.\n* Have ocular conditions requiring immediate surgical correction (e.g. retinal tear or detachment).\n* Require continuation of concomitant medications precluded by this protocol, e.g., antimetabolites, alkylating agents, selected nucleoside analogs, and selected cytokines and other medications listed in the protocol.\n* History of hypersensitivity to acyclovir or ganciclovir.\n* Dementia, decreased mentation or other encephalopathic signs and symptoms which would interfere with the ability of the subject to give informed consent or comply with the protocol.\n\nPrior Medication:\n\nThe following are excluded:\n\n\\- Previous use of anti-cytomegalovirus drug (e.g., ganciclovir, foscarnet, FIAC, or CMV hyperimmune globulin) within one month of study entry.'}, 'identificationModule': {'nctId': 'NCT00002257', 'briefTitle': 'A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment With Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People With AIDS', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment With Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People With AIDS', 'orgStudyIdInfo': {'id': '059B'}, 'secondaryIdInfos': [{'id': 'ICM 1653'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Ganciclovir', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94704', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'East Bay AIDS Ctr', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '94114', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Davies Med Ctr / c/o HIV Institute', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Dr David Busch', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown Univ Med Ctr', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Med Service', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Veterans Administration Med Ctr', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Rush Presbyterian - Saint Luke's Med Ctr", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Med Ctr', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Univ Med Ctr', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Cornell Univ Med College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Buckley Braffman Stern Med Associates', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77550', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ TX Galveston Med Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "Saint Paul's Hosp", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}}}}