Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-03-03 @ 4:15 AM
Study NCT ID:
NCT00666705
Status:
COMPLETED
Last Update Posted:
2013-01-25
First Post:
2008-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study To Evaluate An Interaction Between Maraviroc And Raltegravir In Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077592', 'term': 'Maraviroc'}, {'id': 'D000068898', 'term': 'Raltegravir Potassium'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.govCallCenter@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of \\< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \\< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Maraviroc', 'description': '300 milligrams (mg) every 12 hours on Study Days 6-11', 'otherNumAffected': 4, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Maraviroc + Raltegravir', 'description': 'On Study Days 12-14: Raltegravir 400 milligrams (mg) every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)', 'otherNumAffected': 4, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Raltegravir', 'description': '400 milligrams (mg) every 12 hours on Study Days 1-3 Followed by washout on Study Days 4-5', 'otherNumAffected': 3, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Peripheral neurophathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maraviroc Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc + Raltegravir (Test)', 'description': 'On Study Days 12-14: Raltegravir 400 mg every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)'}, {'id': 'OG001', 'title': 'Maraviroc (Reference)', 'description': '300 mg every 12 hours on Study Days 6-11'}], 'classes': [{'categories': [{'measurements': [{'value': '2551.9', 'spread': '786.68', 'groupId': 'OG000'}, {'value': '2971.6', 'spread': '841.65', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio (percent)', 'ciPctValue': '90', 'paramValue': '85.76', 'ciLowerLimit': '79.89', 'ciUpperLimit': '92.07', 'estimateComment': 'Ratio (percent) (Test/Reference) of Adjusted Geometric Means', 'groupDescription': 'The alternate hypothesis of bioequivalence is that there is no difference between treatment groups. For maraviroc, a sample size of 18 subjects provided 99% power that the 90% confidence interval (CI) for the ratio of Test (raltegravir co-administered with maraviroc) to Reference (maraviroc administered alone) treatment for the area under the plasma concentration-time profile over the dosing interval (AUCτ) would lie within the acceptance region of (80%, 125%).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Natural log transformed AUCτ was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Days 11 and 14', 'description': 'Effect of raltegravir on pharmacokinetics of maraviroc (comparison of AUCτ of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir).', 'unitOfMeasure': 'ng.hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.'}, {'type': 'PRIMARY', 'title': 'Maraviroc Pharmacokinetic (PK) Parameter: Maximum Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc + Raltegravir (Test)', 'description': 'On Study Days 12-14: Raltegravir 400 mg every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)'}, {'id': 'OG001', 'title': 'Maraviroc (Reference)', 'description': '300 mg every 12 hours on Study Days 6-11'}], 'classes': [{'categories': [{'measurements': [{'value': '691.6', 'spread': '322.24', 'groupId': 'OG000'}, {'value': '851.4', 'spread': '349.38', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio (percent)', 'ciPctValue': '90', 'paramValue': '79.48', 'ciLowerLimit': '67.19', 'ciUpperLimit': '94.02', 'estimateComment': 'Ratio (percent) (Test/Reference) of Adjusted Geometric Means', 'groupDescription': 'The alternate hypothesis of bioequivalence is that there is no difference between treatment groups. For maraviroc, a sample size of 18 subjects provided 91% power that the 90% CI for the ratio of Test (raltegravir co-administered with maraviroc) to Reference (maraviroc administered alone) treatment for the maximum concentration (Cmax) would lie within the acceptance region of (80%, 125%).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Natural log transformed Cmax was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Days 11 and 14', 'description': 'Effect of raltegravir on pharmacokinetics of maraviroc (comparison of Cmax of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir). Cmax is the maximum plasma concentration.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.'}, {'type': 'PRIMARY', 'title': 'Raltegravir Pharmacokinetics (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc + Raltegravir (Test)', 'description': 'On Study Days 12-14: Raltegravir 400mg every 12 hours, maraviroc 300mg every 12 hours (AM doses only on Day 14)'}, {'id': 'OG001', 'title': 'Raltegravir (Reference)', 'description': '400 mg every 12 hours on Study Days 1-3 Followed by washout on Study Days 4-5'}], 'classes': [{'categories': [{'measurements': [{'value': '6287.5', 'spread': '3979.30', 'groupId': 'OG000'}, {'value': '9122.4', 'spread': '5311.34', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio (percent)', 'ciPctValue': '90', 'paramValue': '63.25', 'ciLowerLimit': '44.27', 'ciUpperLimit': '90.39', 'estimateComment': 'Ratio (percent) (Test/Reference) of Adjusted Geometric Means', 'groupDescription': 'For raltegravir, a sample size of 18 subjects provided 90% CIs for the difference between treatments of raltegravir (±0.205) on the natural log scale for AUCτ, with 90% coverage probability.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Natural log transformed AUCτ was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Days 3 and 14', 'description': 'Effect of maraviroc on pharmacokinetics of raltegravir (comparison of AUCτ of raltegravir co-administered with maraviroc (Test) versus raltegravir administered alone (Reference)). Pharmacokinetics were assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir).', 'unitOfMeasure': 'ng.hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Maraviroc Pharmacokinetic (PK) Parameter: 12-Hour Trough Concentration (C12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc + Raltegravir (Test)', 'description': 'On Study Days 12-14: Raltegravir 400 mg every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)'}, {'id': 'OG001', 'title': 'Maraviroc (Reference)', 'description': '300 mg every 12 hours on Study Days 6-11'}], 'classes': [{'categories': [{'measurements': [{'value': '48.34', 'spread': '13.70', 'groupId': 'OG000'}, {'value': '53.36', 'spread': '14.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio (percent)', 'ciPctValue': '90', 'paramValue': '90.33', 'ciLowerLimit': '85.28', 'ciUpperLimit': '95.68', 'estimateComment': 'Ratio (percent) (Test/Reference) of Adjusted Geometric Means', 'groupDescription': 'The alternate hypothesis of bioequivalence is that there is no difference between treatment groups.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Natural log transformed C12 was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Days 11 and 14', 'description': 'Effect of raltegravir on pharmacokinetics of maraviroc (comparison of C12 of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir). C12 is the 12-hour trough concentration.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.'}, {'type': 'PRIMARY', 'title': 'Raltegravir Pharmacokinetics (PK) Parameter: Maximum Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc + Raltegravir (Test)', 'description': 'On Study Days 12-14: Raltegravir 400mg every 12 hours, maraviroc 300mg every 12 hours (AM doses only on Day 14)'}, {'id': 'OG001', 'title': 'Raltegravir (Reference)', 'description': '400 mg every 12 hours on Study Days 1-3 Followed by washout on Study Days 4-5'}], 'classes': [{'categories': [{'measurements': [{'value': '2169.6', 'spread': '1570.58', 'groupId': 'OG000'}, {'value': '3026.6', 'spread': '2030.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio (percent)', 'ciPctValue': '90', 'paramValue': '66.77', 'ciLowerLimit': '41.22', 'ciUpperLimit': '108.15', 'estimateComment': 'Ratio (percent) (Test/Reference) of Adjusted Geometric Means', 'groupDescription': 'For raltegravir, a sample size of 18 subjects provided 90% CIs for the difference between treatments of raltegravir (±0.293) on the natural log scale for Cmax, with 90% coverage probability.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Natural log transformed Cmax was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Days 3 and 14', 'description': 'Effect of maraviroc on pharmacokinetics of raltegravir (comparison of Cmax of raltegravir co-administered with maraviroc (Test) versus raltegravir administered alone (Reference)). Pharmacokinetics assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir). Cmax is the maximum plasma concentration.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Raltegravir Pharmacokinetics (PK) Parameter: 12-Hour Trough Concentration (C12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc + Raltegravir (Test)', 'description': 'On Study Days 12-14: Raltegravir 400mg every 12 hours, maraviroc 300mg every 12 hours (AM doses only on Day 14)'}, {'id': 'OG001', 'title': 'Raltegravir (Reference)', 'description': '400 mg every 12 hours on Study Days 1-3 Followed by washout on Study Days 4-5'}], 'classes': [{'categories': [{'measurements': [{'value': '51.16', 'spread': '22.64', 'groupId': 'OG000'}, {'value': '73.69', 'spread': '36.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio (percent)', 'ciPctValue': '90', 'paramValue': '72.42', 'ciLowerLimit': '57.82', 'ciUpperLimit': '90.71', 'estimateComment': 'Ratio (percent) (Test/Reference) of Adjusted Geometric Means', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Natural log transformed C12 was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Days 3 and 14', 'description': 'Effect of maraviroc on pharmacokinetics of raltegravir (comparison of C12 of raltegravir co-administered with maraviroc (Test) vs. raltegravir administered alone (Reference)). Pharmacokinetics were assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir). C12 is the 12-hour trough concentration.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Maraviroc / Raltegravir (Alone and Co-administered)', 'description': 'All subjects received the following fixed sequence study treatments:\n\nDays 1-3: raltegravir 400 milligrams (mg) every 12 hours (AM dose on Day 3) Days 4-5: washout Days 6-11: maraviroc 300 mg every 12 hours Days 12-14: raltegravir 400 mg every 12 hours and maraviroc 300 mg every 12 hours (AM doses on Day 14).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Raltegravir Alone (Days 1 - 3)', 'achievements': [{'comment': '400 mg Raltegravir every 12 hours (AM dose on Day 3)', 'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Washout (Days 4 - 5)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Maraviroc Alone (Days 6 - 11)', 'achievements': [{'comment': '300 mg Maraviroc every 12 hours', 'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Raltegravir + Maraviroc (Days 12 - 14)', 'achievements': [{'comment': '400 mg Raltegravir every 12 hours plus 300 mg Maraviroc every 12 hours (AM doses only on Day 14)', 'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'One site in the United States', 'preAssignmentDetails': 'Subjects were to be healthy male or female subjects between the ages of 18 and 55 years, inclusive. Subjects were required to meet all eligibility criteria prior to randomization into the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Maraviroc / Raltegravir (Alone and Co-administered)', 'description': 'All subjects received the following fixed sequence study treatments:\n\nDays 1-3: raltegravir 400 mg every 12 hours (AM dose on Day 3) Days 4-5: washout Days 6-11: maraviroc 300 mg every 12 hours Days 12-14: raltegravir 400 mg every 12 hours and maraviroc 300 mg every 12 hours (AM doses on Day 14).'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.3', 'spread': '9.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-16', 'studyFirstSubmitDate': '2008-04-23', 'resultsFirstSubmitDate': '2009-03-05', 'studyFirstSubmitQcDate': '2008-04-23', 'lastUpdatePostDateStruct': {'date': '2013-01-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-04-10', 'studyFirstPostDateStruct': {'date': '2008-04-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Maraviroc Pharmacokinetic (PK) Parameter: 12-Hour Trough Concentration (C12)', 'timeFrame': 'Days 11 and 14', 'description': 'Effect of raltegravir on pharmacokinetics of maraviroc (comparison of C12 of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir). C12 is the 12-hour trough concentration.'}, {'measure': 'Raltegravir Pharmacokinetics (PK) Parameter: 12-Hour Trough Concentration (C12)', 'timeFrame': 'Days 3 and 14', 'description': 'Effect of maraviroc on pharmacokinetics of raltegravir (comparison of C12 of raltegravir co-administered with maraviroc (Test) vs. raltegravir administered alone (Reference)). Pharmacokinetics were assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir). C12 is the 12-hour trough concentration.'}], 'primaryOutcomes': [{'measure': 'Maraviroc Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)', 'timeFrame': 'Days 11 and 14', 'description': 'Effect of raltegravir on pharmacokinetics of maraviroc (comparison of AUCτ of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir).'}, {'measure': 'Maraviroc Pharmacokinetic (PK) Parameter: Maximum Concentration (Cmax)', 'timeFrame': 'Days 11 and 14', 'description': 'Effect of raltegravir on pharmacokinetics of maraviroc (comparison of Cmax of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir). Cmax is the maximum plasma concentration.'}, {'measure': 'Raltegravir Pharmacokinetics (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)', 'timeFrame': 'Days 3 and 14', 'description': 'Effect of maraviroc on pharmacokinetics of raltegravir (comparison of AUCτ of raltegravir co-administered with maraviroc (Test) versus raltegravir administered alone (Reference)). Pharmacokinetics were assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir).'}, {'measure': 'Raltegravir Pharmacokinetics (PK) Parameter: Maximum Concentration (Cmax)', 'timeFrame': 'Days 3 and 14', 'description': 'Effect of maraviroc on pharmacokinetics of raltegravir (comparison of Cmax of raltegravir co-administered with maraviroc (Test) versus raltegravir administered alone (Reference)). Pharmacokinetics assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir). Cmax is the maximum plasma concentration.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['maraviroc', 'raltegravir', 'drug interaction study', 'healthy volunteers'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4001082&StudyName=A%20Study%20To%20Evaluate%20An%20Interaction%20Between%20Maraviroc%20And%20Raltegravir%20In%20Healthy%20Subjects', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'An open label study to evaluate an interaction between maraviroc and raltegravir in healthy subjects.', 'detailedDescription': 'Drug interaction study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and/or female subjects between 18 and 55 years of age.\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant disease or clinical findings at screening'}, 'identificationModule': {'nctId': 'NCT00666705', 'briefTitle': 'A Study To Evaluate An Interaction Between Maraviroc And Raltegravir In Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'An Open Label Phase 4 Study To Evaluate An Interaction Between Maraviroc And Raltegravir In Healthy Subjects', 'orgStudyIdInfo': {'id': 'A4001082'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Maraviroc alone', 'interventionNames': ['Drug: Maraviroc']}, {'type': 'EXPERIMENTAL', 'label': 'Maraviroc + Raltegravir', 'interventionNames': ['Drug: Maraviroc', 'Drug: Raltegravir']}, {'type': 'EXPERIMENTAL', 'label': 'Raltegravir alone', 'interventionNames': ['Drug: Raltegravir']}], 'interventions': [{'name': 'Maraviroc', 'type': 'DRUG', 'otherNames': ['Selzentry, Celsentri'], 'description': '300 milligrams(mg) every 12 hours Days 6-11', 'armGroupLabels': ['Maraviroc alone']}, {'name': 'Maraviroc', 'type': 'DRUG', 'description': 'Days 12-14: Raltegravir 400 milligrams(mg) every 12 hours, maraviroc 300 milligrams(mg) every 12 hours (AM doses only on Day 14)', 'armGroupLabels': ['Maraviroc + Raltegravir']}, {'name': 'Raltegravir', 'type': 'DRUG', 'description': 'Days 12-14: Raltegravir 400 milligrams(mg) every 12 hours, maraviroc 300 milligrams(mg) every 12 hours (AM doses only on Day 14)', 'armGroupLabels': ['Maraviroc + Raltegravir']}, {'name': 'Raltegravir', 'type': 'DRUG', 'description': '400 milligrams(mg) every 12 hours Days 1-3 Followed by washout Days 4-5', 'armGroupLabels': ['Raltegravir alone']}]}, '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': 'ViiV Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}