Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-27 @ 6:45 AM
Study NCT ID:
NCT00352066
Status:
COMPLETED
Last Update Posted:
2011-06-23
First Post:
2006-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Apricitabine and Tipranavir When Dosed Alone or Together
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'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': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C508042', 'term': 'apricitabine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-21', 'studyFirstSubmitDate': '2006-07-12', 'studyFirstSubmitQcDate': '2006-07-12', 'lastUpdatePostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the single dose pharmacokinetics of apricitabine when administered alone and in the presence of steady state concentrations of tipranavir 500 mg administered twice daily in combination with ritonavir 200 mg twice daily.', 'timeFrame': 'day 1 and day 10'}], 'secondaryOutcomes': [{'measure': 'To compare the steady state pharmacokinetics of tipranavir 500 mg administered twice daily with ritonavir 200mg in the presence and absence of apricitabine.', 'timeFrame': 'day 9 and day 10'}, {'measure': 'To evaluate the safety and tolerability of apricitabine administered in combination with tipranavir and ritonavir.', 'timeFrame': 'day 10'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Human Immunodeficiency Virus', 'anti-retroviral therapy', 'nucleoside analogue', 'reverse transcriptase', 'apricitabine', 'tipranavir', 'bioequivalence', 'drug-drug interaction', 'pharmacokinetics'], 'conditions': ['HIV Infection']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to see if apricitabine or tipranavir affect the levels of each other in the blood (pharmacokinetic interaction) when they are dosed together.', 'detailedDescription': 'Apricitabine is a new NRTI in development for treatment of drug resistant HIV. Tipranavir is a recently licensed protease inhibitor for treatment of drug resistant HIV. Tipranavir affects the plasma concentration of some other drugs when they are used together with tipranavir. This study will examine whether the pharmacokinetics of apricitabine are changed when it is dosed together with tipranavir compared to apricitabine alone. Also, the pharmacokinetics of tipranavir will be examined at steady state when it is dosed alone and when it is dosed together with apricitabine. Information on the safety and tolerability of the two drugs when dosed together will also be obtained.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy males 18-40 years old\n* non-smokers\n* no clinically significant medical history\n\nExclusion Criteria:\n\n* current or relevant previous medical history of significance\n* hepatitis B, hepatitis C, or HIV positive\n* current use of prescription or OTC medications\n* use of illicit substances or alcohol (\\>14 drinks/week)'}, 'identificationModule': {'nctId': 'NCT00352066', 'briefTitle': 'Pharmacokinetics of Apricitabine and Tipranavir When Dosed Alone or Together', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avexa'}, 'officialTitle': 'A Phase I, Open Label, Controlled, Intra-subject Comparison Study to Investigate the Effect of Co-administration Upon the Pharmacokinetics of Tipranavir (Ritonavir Boosted) and Apricitabine.', 'orgStudyIdInfo': {'id': 'AVX-102'}}, 'armsInterventionsModule': {'interventions': [{'name': 'apricitabine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '49007', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Jasper Clinic Inc', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}], 'overallOfficials': [{'name': 'Susan W Cox, Ph D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Avexa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avexa', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Susan Cox', 'oldOrganization': 'Avexa'}}}}