Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-01-05 @ 6:10 PM
Study NCT ID:
NCT00745368
Status:
COMPLETED
Last Update Posted:
2012-10-10
First Post:
2008-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068898', 'term': 'Raltegravir Potassium'}], 'ancestors': [{'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rob.dicenzo@acphs.edu', 'phone': '518 694 7228', 'title': 'Robert DiCenzo', 'organization': 'University of Rochester'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to limited sample size and large intersubject variability, more study comparing male and female GT concentrations is needed.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Raltegravir', 'description': 'Raltegravir 400 mg tablets twice daily', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Raltegravir Male Genital Tract Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir', 'description': 'Raltegravir 400 mg tablets twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '485.1', 'groupId': 'OG000', 'lowerLimit': '428.5', 'upperLimit': '753.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8-10 hours after raltegravir dose', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Raltegravir Female Genital Tract Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir', 'description': 'Raltegravir 400 mg tablets twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '879.1', 'groupId': 'OG000', 'lowerLimit': '128.4', 'upperLimit': '3541.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8-10 hours after raltegravir dose', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Male Paired Plasma Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir', 'description': 'Raltegravir 400 mg tablets twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000', 'lowerLimit': '104.3', 'upperLimit': '231.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8-10 hours after raltegravir dose', 'description': 'This sample was taken as close to the time of genital tract sample as possible', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Female Paired Plasma Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir', 'description': 'Raltegravir 400 mg tablets twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '264.6', 'groupId': 'OG000', 'lowerLimit': '129.4', 'upperLimit': '1256.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8-10 hours after raltegravir dose', 'description': 'This sample was taken as close to the time of genital tract sample as possible', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Male Time Since Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir', 'description': 'Raltegravir 400 mg tablets twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '8.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8-10 hours after raltegravir dose', 'description': 'This measure describes the amount of time that expired between when the dose was administered and when the sample was taken', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Female Time Since Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir', 'description': 'Raltegravir 400 mg tablets twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8-10 hours after raltegravir dose', 'description': 'This measure describes the amount of time that expired between when the dose was administered and when the sample was taken', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Male Genital Tract:Plasma Concentration Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir', 'description': 'Raltegravir 400 mg tablets twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '5.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8-10 hours after raltegravir dose', 'description': 'Units of raltegravir concentration for genital tract and plasma sample are ng/mL', 'unitOfMeasure': 'ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Female Genital Tract:Plasma Concentration Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Raltegravir', 'description': 'Raltegravir 400 mg tablets twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '5.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8-10 hours after raltegravir dose', 'description': 'Units of raltegravir concentration for genital tract and plasma sample are ng/mL', 'unitOfMeasure': 'ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Raltegravir', 'description': 'Raltegravir 400 mg tablets twice daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Of the 28 subjects who enrolled, 19 participated in a study visit', 'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '3 male subjects were unable to provide a sample and are not included in the results', 'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Unable to provide sample', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Raltegravir', 'description': 'Raltegravir 400 mg tablets twice daily'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47', 'spread': '8.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-07', 'studyFirstSubmitDate': '2008-09-01', 'resultsFirstSubmitDate': '2012-07-25', 'studyFirstSubmitQcDate': '2008-09-02', 'lastUpdatePostDateStruct': {'date': '2012-10-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-07', 'studyFirstPostDateStruct': {'date': '2008-09-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Raltegravir Male Genital Tract Concentration', 'timeFrame': '8-10 hours after raltegravir dose'}, {'measure': 'Raltegravir Female Genital Tract Concentration', 'timeFrame': '8-10 hours after raltegravir dose'}, {'measure': 'Male Paired Plasma Concentration', 'timeFrame': '8-10 hours after raltegravir dose', 'description': 'This sample was taken as close to the time of genital tract sample as possible'}, {'measure': 'Female Paired Plasma Concentration', 'timeFrame': '8-10 hours after raltegravir dose', 'description': 'This sample was taken as close to the time of genital tract sample as possible'}, {'measure': 'Male Time Since Last Dose', 'timeFrame': '8-10 hours after raltegravir dose', 'description': 'This measure describes the amount of time that expired between when the dose was administered and when the sample was taken'}, {'measure': 'Female Time Since Last Dose', 'timeFrame': '8-10 hours after raltegravir dose', 'description': 'This measure describes the amount of time that expired between when the dose was administered and when the sample was taken'}, {'measure': 'Male Genital Tract:Plasma Concentration Ratio', 'timeFrame': '8-10 hours after raltegravir dose', 'description': 'Units of raltegravir concentration for genital tract and plasma sample are ng/mL'}, {'measure': 'Female Genital Tract:Plasma Concentration Ratio', 'timeFrame': '8-10 hours after raltegravir dose', 'description': 'Units of raltegravir concentration for genital tract and plasma sample are ng/mL'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'Raltegravir', 'pharmacokinetics', 'Treatment Experienced'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to determine how much raltegravir gets into the male and female genital tract.', 'detailedDescription': 'Although we have many medications to fight the HIV virus, very little is known about how much of these medications get into the genital tract. Raltegravir is a new HIV medication that blocks HIV growth and lowers the amount of virus in the blood in a way that is different than all other currently available HIV medications. Raltegravir was recently approved by the Food and Drug Administration (FDA) for use in HIV infected patients, but there is very little information concerning how much raltegravir will reach the genital tract of men or women. The purpose of this research study is to determine how much raltegravir gets into the male and female genital tract.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documentation of blood seropositive for HIV based on self report and confirmed by ELISA and Western blot or detectable HIV RNA\n\n * Stable anti-retroviral regimen for at least 3 weeks prior to enrollment\n * Capable of giving informed consent\n * Age 18 years and older\n\nExclusion Criteria:\n\n* Neoplasms\n* Women who are pregnant or nursing\n* History or current evidence of any significant acute or chronic medical illness that in the opinion of the investigator would preclude the subject from safely participating in the study\n* Current use of phenobarbital, phenytoin, or rifampin\n* Any major surgery within 4 weeks of enrollment\n* Blood transfusion within 4 weeks of enrollment\n* Inability to tolerate oral medication\n* Inability to tolerate venipuncture, venous access, or genital tract sampling\n* History of recent (within 6 months) drug or alcohol abuse\n* Evidence of organ dysfunction or any clinically significant deviation from normal in the medical history, physical examination, vital signs, and or clinical laboratory determinations that in the opinion of the investigator would preclude the subject from safely participating in the study\n* Any other sound medical, psychiatric and or social reason for exclusion as determined by the investigator\n* History of allergy to study medication or related compounds'}, 'identificationModule': {'nctId': 'NCT00745368', 'briefTitle': 'Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women', 'orgStudyIdInfo': {'id': '33113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Raltegravir', 'description': 'Raltegravir 400 mg tablets twice daily', 'interventionNames': ['Drug: Raltegravir']}], 'interventions': [{'name': 'Raltegravir', 'type': 'DRUG', 'description': '400 mg tablets twice daily during duration of trial', 'armGroupLabels': ['Raltegravir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adjunct Assistant Professor of Medicine', 'investigatorFullName': 'Robert Dicenzo', 'investigatorAffiliation': 'University of Rochester'}}}}