Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT00002251
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 Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir
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': 'D017088', 'term': 'AIDS-Related Opportunistic 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': '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': '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': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1991-05', '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', 'Cytomegalovirus Infections', 'Acquired Immunodeficiency Syndrome', 'Biological Availability'], 'conditions': ['Cytomegalovirus Infections', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '8690817', 'type': 'BACKGROUND', 'citation': 'Lavelle J, Follansbee S, Trapnell CB, Buhles WC, Griffy KG, Jung D, Dorr A, Connor J. Effect of food on the relative bioavailability of oral ganciclovir. J Clin Pharmacol. 1996 Mar;36(3):238-41. doi: 10.1002/j.1552-4604.1996.tb04193.x.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to determine the influence of food on the absorption and relative bioavailability of oral ganciclovir by comparing the absorption of oral ganciclovir in a fed and fasting state at steady state plasma levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', '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, or culture of HIV.\n* Documented confirmation of present or past CMV infection.\n* Must understand the nature of the study, agree to tests required in the protocol, and must understand and sign an informed Consent form approved by the appropriate Institutional Review Board and by Syntex.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Uncontrolled diarrhea or clinically significant gastrointestinal symptoms including persistent nausea or abdominal pain.\n\nConcurrent Medication:\n\nExcluded:\n\n* Antimetabolites. Interferons. Other nucleoside analogs. Zidovudine (AZT). Any investigational drug.\n\nPatients with the following are excluded:\n\n* Any concomitant conditions listed in Exclusion Co-Existing Conditions.\n* Karnofsky score \\< 70.\n* Hypersensitivity to acyclovir.\n* Displaying signs of dementia or decreased mentation which would interfere with the ability of the subject to follow protocol schedule.\n\nPrior Medication:\n\nExcluded:\n\n* Anti-cytomegalovirus therapy including ganciclovir therapy for treatment of CMV disease.\n* Excluded within 4 days of study entry:\n* Antimetabolites.\n* Interferons.\n* Other nucleoside analogs.\n* Zidovudine (AZT).'}, 'identificationModule': {'nctId': 'NCT00002251', 'briefTitle': 'A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir', 'orgStudyIdInfo': {'id': '059A'}, 'secondaryIdInfos': [{'id': 'ICM 1775'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Ganciclovir', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94114', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Davies Med Ctr', '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}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}}}}