Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-27 @ 11:34 PM
Study NCT ID:
NCT01009034
Status:
COMPLETED
Last Update Posted:
2014-09-09
First Post:
2009-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Concentrations of Maraviroc in the Semen of HIV-Infected Men
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tantoniou@smh.toronto.on.ca', 'phone': '4164657936', 'title': 'Tony Antoniou', 'organization': 'Maple Leaf Research'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '12 Male HIV-positive Patients', 'description': 'Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.\n\nMeasuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Semen to Plasma Ratio of HIV Concentration During the Dosing Interval for Dar, Evr, Mar & Ral.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '10 Male HIV-positive Patients', 'description': 'Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.\n\nMeasuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period.'}], 'classes': [{'title': 'dar', 'categories': [{'measurements': [{'value': '0.20', 'groupId': 'OG000', 'lowerLimit': '0.14', 'upperLimit': '0.24'}]}]}, {'title': 'evr', 'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '0.23'}]}]}, {'title': 'mar', 'categories': [{'measurements': [{'value': '0.92', 'groupId': 'OG000', 'lowerLimit': '0.59', 'upperLimit': '1.91'}]}]}, {'title': 'ral', 'categories': [{'measurements': [{'value': '4.32', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '5.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. Blood samples were collected within 1 hour of the semen sample.', 'description': 'We used a staggered sampling approach in which semen samples were produced by participants over several days at different sampling times relative to the morning dose of antiretrovirals. Specifi- cally, semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. We collected corresponding blood samples within 1 hour of the semen sample. For each participant a single value (the HIV concentration ratio) was calculated as the minimum HIV concentration in the semen over the minimum HIV concentration in the blood throughout the dosing interval.', 'unitOfMeasure': 'Inhibitory concentration ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'We used a staggered sampling approach in which semen samples were produced by participants over several days at different sampling times relative to the morning dose of antiretrovirals.'}, {'type': 'SECONDARY', 'title': 'Determine the Extent of Maraviroc Penetration Into Semen by Obtaining Semen to Plasma Ratios Across the Dosing Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '10 Male HIV-positive Patients', 'description': 'Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.\n\nMeasuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.62', 'groupId': 'OG000', 'lowerLimit': '0.23', 'upperLimit': '2.45'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. Blood samples were collected within 1 hour of the semen sample', 'description': 'For each participant, the Maraviroc penetration ratio was calculated as the maximum Maraviroc concentration in the semen over the maximum Maraviroc concentration in the blood throughout the dosing interval.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Determine the Area Under the Concentration Time Curve of Maraviroc in Semen.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '10 Male HIV-positive Patients', 'description': 'Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.\n\nMeasuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.43', 'groupId': 'OG000', 'lowerLimit': '1.83', 'upperLimit': '7.96'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'unitOfMeasure': 'h*mg/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '10 Male HIV-positive Patients', 'description': 'Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.\n\nMeasuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '10 Male HIV-positive Patients', 'description': 'Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.\n\nMeasuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000', 'lowerLimit': '46', 'upperLimit': '57'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '10 HIV+ men on maraviroc with VL \\<50 copies per M'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-08', 'studyFirstSubmitDate': '2009-11-05', 'resultsFirstSubmitDate': '2014-06-16', 'studyFirstSubmitQcDate': '2009-11-05', 'lastUpdatePostDateStruct': {'date': '2014-09-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-08', 'studyFirstPostDateStruct': {'date': '2009-11-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Semen to Plasma Ratio of HIV Concentration During the Dosing Interval for Dar, Evr, Mar & Ral.', 'timeFrame': 'Semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. Blood samples were collected within 1 hour of the semen sample.', 'description': 'We used a staggered sampling approach in which semen samples were produced by participants over several days at different sampling times relative to the morning dose of antiretrovirals. Specifi- cally, semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. We collected corresponding blood samples within 1 hour of the semen sample. For each participant a single value (the HIV concentration ratio) was calculated as the minimum HIV concentration in the semen over the minimum HIV concentration in the blood throughout the dosing interval.'}], 'secondaryOutcomes': [{'measure': 'Determine the Extent of Maraviroc Penetration Into Semen by Obtaining Semen to Plasma Ratios Across the Dosing Interval', 'timeFrame': 'Semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. Blood samples were collected within 1 hour of the semen sample', 'description': 'For each participant, the Maraviroc penetration ratio was calculated as the maximum Maraviroc concentration in the semen over the maximum Maraviroc concentration in the blood throughout the dosing interval.'}, {'measure': 'Determine the Area Under the Concentration Time Curve of Maraviroc in Semen.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Maraviroc Concentrations in Semen']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine if concentrations of maraviroc in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dose interval.\n\nThe secondary objective is to determine the extent of maraviroc penetration into semen by obtaining semen to plasma ratios across the dosing interval, to determine the area under the concentration time curve of maraviroc in semen, and to determine the variability in the penetration of maraviroc into the seminal compartment over the maraviroc dosing period.', 'detailedDescription': 'The patient population will consist of 12 male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months. Patients will be enrolled from one clinic in downtown Toronto and a hospital affiliated HIV specialty clinic in Ottawa, Ontario. Eligible patients will have evidence of full virologic suppression (HIV viral load \\< 50 copies/mL) at least one month prior to enrollment in the study. No changes will be made to the patients antiretroviral therapy during the course of the study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '12 HIV-positive males', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* HIV infected male\n* 18 years old or older\n* on maraviroc twice daily as part of their antiretroviral regimen for at least 3 months prior to screening\n* viral load \\< 50 copies/mL at least one month prior to enrolling\n* able to read, understand and sign a written informed consent prior to initiation of the study\n* medically stable at the time of the study, with no evidence of acute illness\n\nExclusion Criteria:\n\n* having difficulty adhering to current antiretroviral therapy\n* patient is expected to have difficulties adhering with study protocol\n* patients with malignancy, or acute renal or liver disease\n* patient with active AIDS-defining illness\n* patient with any medical, psychiatric or other circumstance that may impede the provision of informed consent\n* patient with any of the following abnormalities at the time of screening:\n* hemoglobin \\< 85 g/L\n* absolute neutrophil count \\< 1000 cells/uL\n* platelet count \\< 50,000 cells/uL\n* AST, ALT or total bilirubin \\> 3 times the upper limit of normal\n* serum creatinine \\> 1.5 times upper limit of normal\n* patient receiving concomitant therapy with rifampin or St. John's wort"}, 'identificationModule': {'nctId': 'NCT01009034', 'acronym': 'NCT01009034', 'briefTitle': 'Concentrations of Maraviroc in the Semen of HIV-Infected Men', 'organization': {'class': 'OTHER', 'fullName': 'Canadian Immunodeficiency Research Collaborative'}, 'officialTitle': 'Study to Determine the Concentrations of Maraviroc in Semen, the Seminal to Plasma Ratio of Maraviroc and the Variability in Seminal to Plasma Ratios Over the Maraviroc Dosing Period.', 'orgStudyIdInfo': {'id': 'WS 353380'}}, 'armsInterventionsModule': {'armGroups': [{'label': '12 male HIV-positive patients', 'description': 'Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.', 'interventionNames': ['Other: Measuring semen samples']}], 'interventions': [{'name': 'Measuring semen samples', 'type': 'OTHER', 'description': 'Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period.', 'armGroupLabels': ['12 male HIV-positive patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5B1L6', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Canadian Immunodeficiency Research Collaborative', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Canadian Immunodeficiency Research Collaborative', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}