Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT01220232
Status:
COMPLETED
Last Update Posted:
2011-02-04
First Post:
2010-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C492871', 'term': 'abacavir, lamivudine drug combination'}, {'id': 'C531151', 'term': 'UK 453,061'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-03', 'studyFirstSubmitDate': '2010-10-12', 'studyFirstSubmitQcDate': '2010-10-12', 'lastUpdatePostDateStruct': {'date': '2011-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To estimate the effect of steady state lersivirine 750 mg on the steady state pharmacokinetics of abacavir/lamivudine.', 'timeFrame': '17 days'}], 'secondaryOutcomes': [{'measure': 'To investigate the safety and tolerability of lersivirine when co-administered with abacavir/lamivudine.', 'timeFrame': '17 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lersivirine', 'UK-453', '061', 'NNRTI', 'Abacavir', 'Lamivudine', 'Combivir', 'Pharmacokinetics', 'Drug Interaction', 'HIV', 'AIDS'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5271048&StudyName=Estimate%20The%20Effect%20Of%20Lersivirine%20On%20The%20Pharmacokinetics%20Of%20Abacavir/Lamivudine%20In%20Healthy%20Subjects%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This will be an open-label, fixed-sequence, multiple dose crossover study in 14 healthy male and/or female subjects, to estimate the effect of steady state lersivirine on the steady state pharmacokinetics of abacavir/lamivudine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and/or female subjects.\n* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.\n* Total body weight \\>50 kg (110 lbs).\n\nExclusion Criteria:\n\n* History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.\n* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.\n* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.\n* History of hypersensitivity to abacavir, lamivudine and/or lersivirine.'}, 'identificationModule': {'nctId': 'NCT01220232', 'briefTitle': 'Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Open-Label, Fixed-Sequence, Crossover Study To Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects', 'orgStudyIdInfo': {'id': 'A5271048'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Abacavir/Lamivudine', 'interventionNames': ['Drug: Abacavir/Lamivudine']}, {'type': 'EXPERIMENTAL', 'label': 'Lersivirine + Abacavir/Lamivudine', 'interventionNames': ['Drug: Abacavir/Lamivudine', 'Drug: Lersivirine']}], 'interventions': [{'name': 'Abacavir/Lamivudine', 'type': 'DRUG', 'description': 'Abacavir/Lamivudine 600/300 mg QD for 5 days', 'armGroupLabels': ['Abacavir/Lamivudine']}, {'name': 'Abacavir/Lamivudine', 'type': 'DRUG', 'description': 'Abacavir/Lamivudine 600/300 mg QD for 10 days', 'armGroupLabels': ['Lersivirine + Abacavir/Lamivudine']}, {'name': 'Lersivirine', 'type': 'DRUG', 'description': 'Lersivirine 750 mg QD for 10 days', 'armGroupLabels': ['Lersivirine + Abacavir/Lamivudine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ViiV Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}