Ignite Creation Date:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2025-12-29 @ 9:17 PM
Study NCT ID:
NCT00002095
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, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003586', 'term': 'Cytomegalovirus Infections'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D054069', 'term': 'Multiple Acyl Coenzyme A Dehydrogenase Deficiency'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'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': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 700}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1993-11', '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': ['Ganciclovir', 'Cytomegalovirus Infections', 'Acquired Immunodeficiency Syndrome'], 'conditions': ['Cytomegalovirus Infections', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '8618603', 'type': 'BACKGROUND', 'citation': 'Spector SA, McKinley GF, Lalezari JP, Samo T, Andruczk R, Follansbee S, Sparti PD, Havlir DV, Simpson G, Buhles W, Wong R, Stempien M. Oral ganciclovir for the prevention of cytomegalovirus disease in persons with AIDS. Roche Cooperative Oral Ganciclovir Study Group. N Engl J Med. 1996 Jun 6;334(23):1491-7. doi: 10.1056/NEJM199606063342302.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of oral ganciclovir in preventing progression to cytomegalovirus (CMV) disease (e.g., CMV retinitis, gastrointestinal CMV disease) in CMV-infected people with HIV infection and CD4 lymphocyte counts \\<= 100 cells/mm3. To evaluate the efficacy of this drug in reducing morbidity associated with coinfection by both CMV and HIV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Topical or ophthalmic nucleoside analogs.\n\nPatients must have:\n\n* Confirmation of HIV infection.\n* Documented CMV infection.\n* No past or present CMV disease (e.g., retinitis, colitis, esophagitis).\n* Adequate visualization of the retina of both eyes by ophthalmologist.\n* CD4 count \\<= 50 cells/mm3 (in patients WITHOUT a history of an AIDS-defining opportunistic infection or chronic gynecologic infection) OR CD4 count \\<= 100 cells/mm3 (in patients WITH a history of an AIDS-defining opportunistic infection or chronic gynecologic infection).\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Presence of gastrointestinal disease or symptoms not controlled with medications (e.g., persistent nausea, abdominal pain or persistent diarrhea within the past 4 weeks that is not controllable with medication).\n* Inability to comply with protocol.\n\nConcurrent Medication:\n\nExcluded:\n\n* The following nucleoside analogs:\n* IV ganciclovir, IV acyclovir for more than 2 weeks total duration, oral acyclovir at doses \\> 1000 mg/day, vidarabine, amantadine hydrochloride, cytarabine, idoxuridine.\n* FIAU, FIAC, foscarnet, CMV hyperimmune globulin, IV immune globulin, CMV monoclonal antibody, HPMPC.\n* Imipenem-cilastatin (Primaxin).\n\nPatients with the following prior condition are excluded:\n\nHistory of hypersensitivity to acyclovir.\n\nPrior Medication:\n\nExcluded within the past 60 days:\n\nGanciclovir, foscarnet, FIAC, FIAU, CMV hyperimmune globulin, CMV monoclonal antibody, or HPMPC.'}, 'identificationModule': {'nctId': 'NCT00002095', 'briefTitle': 'A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus', 'orgStudyIdInfo': {'id': '059D'}, 'secondaryIdInfos': [{'id': 'ICM 1654'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Ganciclovir', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94705', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'East Bay AIDS Ctr', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '90028', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kraus - Beer Med Group', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UCSD', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'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': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Mount Zion Med Ctr', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco Veterans Administration Med Ctr', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor - UCLA Med Ctr', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'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': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Community Research Initiative', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'AIDS Research Consortium of Atlanta', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Hosp', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Kaplan Cancer Ctr / New York Univ Med Ctr', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'St Lukes - Roosevelt Hosp Ctr', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Cornell Univ Med College / New York Hosp', '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': '15261', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Univ of Pittsburgh / Graduate School of Public Health', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75219', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Oak Lawn Physicians Group', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Infectious Diseases Association of Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}}}}