Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-26 @ 6:07 PM
Study NCT ID:
NCT00000766
Status:
COMPLETED
Last Update Posted:
2011-03-01
First Post:
1999-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CMV Retinitis Retreatment Trial
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': 'D017245', 'term': 'Foscarnet'}, {'id': 'D015774', 'term': 'Ganciclovir'}], 'ancestors': [{'id': 'D010746', 'term': 'Phosphonoacetic Acid'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'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': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'lastUpdateSubmitDate': '2011-02-28', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2011-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1995-09', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Retinitis', 'Ganciclovir', 'Foscarnet', 'Cytomegalovirus Infections', 'Acquired Immunodeficiency Syndrome'], 'conditions': ['Cytomegalovirus Retinitis', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '8721550', 'type': 'BACKGROUND', 'citation': 'Jabs DA. Design of clinical trials for drug combinations: cytomegalovirus retinitis--foscarnet and ganciclovir. The CMV retinitis retreatment trial. Antiviral Res. 1996 Jan;29(1):69-71. doi: 10.1016/0166-3542(95)00921-3.'}]}, 'descriptionModule': {'briefSummary': 'To assess the safety and efficacy of three therapeutic regimens (foscarnet, ganciclovir, or the combination) for recurrent or persistent AIDS-related cytomegalovirus (CMV) retinitis.\n\nAlthough therapy with foscarnet or ganciclovir halts retinitis progression in 90 percent of patients treated, relapses are common and may accelerate due to development of drug resistance, deteriorating immune function, or other factors. Treatment strategies currently being investigated include switching patients from one drug to the other or combining the two drugs.', 'detailedDescription': 'Although therapy with foscarnet or ganciclovir halts retinitis progression in 90 percent of patients treated, relapses are common and may accelerate due to development of drug resistance, deteriorating immune function, or other factors. Treatment strategies currently being investigated include switching patients from one drug to the other or combining the two drugs.\n\nPatients are randomized to receive foscarnet, ganciclovir, or a combination of the two drugs (administered sequentially). Initially, patients undergo single or multiple cycles of induction therapy for 14 days followed by maintenance therapy. Patients in whom the retinitis continues to progress or who are intolerant of the initial treatment switch to the alternative drug for further cycles of induction and maintenance. Patients on the combination arm in whom retinitis continues to progress are given further cycles of the combination at an increased dose, or, if one drug is causing toxicity, are given further cycles with the alternative drug. Patients are followed monthly for 6 months and then every 3 months thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nRequired:\n\n* At least 28 days of prior foscarnet or ganciclovir.\n\nConcurrent Medication:\n\nAllowed:\n\n* G-CSF.\n\nRecommended:\n\n* Antiretroviral therapy.\n\nPatients must have:\n\n* HIV infection or AIDS.\n* Active CMV retinitis after 28 or more days of either foscarnet or ganciclovir therapy.\n* At least one lesion with one-quarter disk area or more that can be photographed.\n* Visual acuity of 3 or more letters on ETDRS chart (5/200 Snellen) in an affected eye.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms and conditions are excluded:\n\n* Media opacity severe enough to preclude visualization of both fundi.\n* Retinal detachment not scheduled for surgical repair.\n\nPatients with the following prior conditions are excluded:\n\n* History of intolerance to ganciclovir or foscarnet sufficient to contraindicate use.\n* History of combination foscarnet/ganciclovir therapy.\n\nActive drug or alcohol abuse sufficient to prevent compliance.'}, 'identificationModule': {'nctId': 'NCT00000766', 'briefTitle': 'CMV Retinitis Retreatment Trial', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'CMV Retinitis Retreatment Trial', 'orgStudyIdInfo': {'id': 'ACTG 228'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Foscarnet sodium', 'type': 'DRUG'}, {'name': 'Ganciclovir', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '920930946', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD - Shiley Eye Ctr / SOCA', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '900957003', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA - Jules Stein Eye Institute / SOCA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF - San Francisco Gen Hosp', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Univ / SOCA', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '212879217', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hosp / SOCA', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Univ Med Ctr / SOCA', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Hosp - Cornell Med Ctr / Sloan - Kettering / SOCA', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '100296574', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Med Ctr / SOCA', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '275997030', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Univ of North Carolina / SOCA', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}}}}