Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:10 AM
Study NCT ID:
NCT00630734
Status:
COMPLETED
Last Update Posted:
2014-05-22
First Post:
2008-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Genetic Predictors of Variability in the Drug-drug Interaction Between Darunavir/Ritonavir and Pravastatin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}], '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': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017035', 'term': 'Pravastatin'}, {'id': 'D000069454', 'term': 'Darunavir'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'C573645', 'term': 'WASH protein, Drosophila'}], 'ancestors': [{'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D005663', 'term': 'Furans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'christina.aquilante@ucdenver.edu', 'phone': '303-724-6126', 'title': 'Christina Aquilante, Pharm.D.', 'organization': 'University of Colorado Denver'}, 'certainAgreement': {'otherDetails': 'Prior to publication or presentation, the PI will provide the sponsor with at least 60 days for review of a manuscript', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study included only heterozygous carriers of the SLCO1B1 \\*15 and \\*17 haplotypes. Pravastatin urine concentrations were not measured; therefore the impact of darunavir/ritonavir on pravastatin renal clearance was not assessed in this population.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pravastatin Alone', 'description': 'Pravastatin 40 mg by mouth daily on days 1-4; Includes 32 participants who received at least one dose of pravastatin 40 mg during days 1-4.', 'otherNumAtRisk': 32, 'otherNumAffected': 13, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Darunavir/Ritonavir Alone', 'description': 'Darunavir/Ritonavir 600/100 mg by mouth twice daily on days 12-14; Includes 31 participants who received at least one dose of darunavir/ritonavir during days 12-14.', 'otherNumAtRisk': 31, 'otherNumAffected': 22, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Pravastatin + Darunavir/Ritonavir', 'description': 'Darunavir/ritonavir 600/100 mg by mouth twice daily and pravastatin 40 mg by mouth once daily on days 15-18. Includes 28 participants who received at least one dose of darunavir/ritonavir and pravastatin during days 15-18.', 'otherNumAtRisk': 28, 'otherNumAffected': 18, 'seriousNumAtRisk': 28, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Headache', 'notes': 'Grade 1 per DAIDS criteria.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'notes': 'Grade 1 per DAIDS criteria.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'notes': 'Grade 1 per DAIDS criteria.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle pain', 'notes': 'Grade 1 per DAIDS criteria.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'notes': 'Grade 1 per DAIDS criteria.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoalbuminemia', 'notes': 'Grade 1 per DAIDS criteria.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea/Vomiting/Dyspepsia/Abdominal Pain', 'notes': 'Grade 1 per DAIDS criteria.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'notes': 'Grade 1 per DAIDS criteria.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anorexia', 'notes': 'Grade 1 per DAIDS criteria.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shoulder/Neck Pain', 'notes': 'Grade 1 per DAIDS criteria.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Angioedema', 'notes': '1 patient experienced grade 2 angioedema (as described by DAIDS criteria). This was not technically SAE, but did require pharmacologic intervention to prevent a more serious reaction.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Relative Change in Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SLCO1B1 Group 1', 'description': 'SLCO1B1\\*1A/\\*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}, {'id': 'OG001', 'title': 'SLCO1B1 Group 2', 'description': 'SLCO1B1 \\*1A/\\*1B or \\*1B/\\*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}, {'id': 'OG002', 'title': 'SLCO1B1 Group 3', 'description': 'Carriers of at least one SLCO1B1 \\*5, \\*15, or \\*17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}], 'classes': [{'categories': [{'measurements': [{'value': '1.09', 'groupId': 'OG000', 'lowerLimit': '0.73', 'upperLimit': '1.46'}, {'value': '1.59', 'groupId': 'OG001', 'lowerLimit': '0.83', 'upperLimit': '2.36'}, {'value': '1.75', 'groupId': 'OG002', 'lowerLimit': '0.52', 'upperLimit': '2.97'}]}]}], 'analyses': [{'pValue': '0.43', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'Threshold of significance was P\\<0.05.', 'groupDescription': 'Relative change data were compared between SLCO1B1 diplotype groups using one-way ANOVA (with post-hoc Bonferroni tests).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose', 'description': 'AUC of pravastatin when administered with darunavir/ritonavir divided by AUC of pravastatin when administered alone. The AUC was measured over a 24-hour dosing interval.', 'unitOfMeasure': 'ng*hr/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.'}, {'type': 'PRIMARY', 'title': 'Relative Change in Pravastatin Maximum Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SLCO1B1 Group 1', 'description': 'SLCO1B1 \\*1A/\\*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}, {'id': 'OG001', 'title': 'SLCO1B1 Group 2', 'description': 'SLCO1B1 \\*1A/\\*1B or \\*1B/\\*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}, {'id': 'OG002', 'title': 'SLCO1B1 Group 3', 'description': 'Carriers of at least one SLCO1B1 \\*5, \\*15, or \\*17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}], 'classes': [{'categories': [{'measurements': [{'value': '1.11', 'groupId': 'OG000', 'lowerLimit': '0.69', 'upperLimit': '1.53'}, {'value': '1.69', 'groupId': 'OG001', 'lowerLimit': '0.83', 'upperLimit': '2.55'}, {'value': '2.32', 'groupId': 'OG002', 'lowerLimit': '0.24', 'upperLimit': '4.40'}]}]}], 'analyses': [{'pValue': '0.28', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose', 'description': 'Cmax of pravastatin when administered with darunavir/ritonavir divided by the Cmax of pravastatin when administered alone.', 'unitOfMeasure': 'ng/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Darunavir Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SLCO1B1 Group 1', 'description': 'SLCO1B1 \\*1A/\\*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}, {'id': 'OG001', 'title': 'SLCO1B1 Group 2', 'description': 'SLCO1B1 \\*1A/\\*1B or \\*1B/\\*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}, {'id': 'OG002', 'title': 'SLCO1B1 Group 3', 'description': 'Carriers of at least one SLCO1B1 \\*5, \\*15, or \\*17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}], 'classes': [{'categories': [{'measurements': [{'value': '58552', 'spread': '29442', 'groupId': 'OG000'}, {'value': '63679', 'spread': '16985', 'groupId': 'OG001'}, {'value': '60156', 'spread': '13909', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.66', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose', 'description': 'AUC of darunavir over a 12-hour dosing interval.', 'unitOfMeasure': 'ng*h/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Darunavir Maximum Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SLCO1B1 Group 1', 'description': 'SLCO1B1 \\*1A/\\*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}, {'id': 'OG001', 'title': 'SLCO1B1 Group 2', 'description': 'SLCO1B1 \\*1A/\\*1B or \\*1B/\\*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}, {'id': 'OG002', 'title': 'SLCO1B1 Group 3', 'description': 'Carriers of at least one SLCO1B1 \\*5, \\*15, or \\*17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}], 'classes': [{'categories': [{'measurements': [{'value': '7770', 'spread': '3483', 'groupId': 'OG000'}, {'value': '8047', 'spread': '2023', 'groupId': 'OG001'}, {'value': '7789', 'spread': '1467', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.85', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose', 'description': 'Cmax of darunavir over a 12-hour dosing interval', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Ritonavir Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SLCO1B1 Group 1', 'description': 'SLCO1B1 \\*1A/\\*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}, {'id': 'OG001', 'title': 'SLCO1B1 Group 2', 'description': 'SLCO1B1 \\*1A/\\*1B or \\*1B/\\*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}, {'id': 'OG002', 'title': 'SLCO1B1 Group 3', 'description': 'Carriers of at least one SLCO1B1 \\*5, \\*15, or \\*17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}], 'classes': [{'categories': [{'measurements': [{'value': '5239', 'spread': '3835', 'groupId': 'OG000'}, {'value': '7178', 'spread': '3520', 'groupId': 'OG001'}, {'value': '7907', 'spread': '3618', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose', 'description': 'AUC of ritonavir over a 12-hour dosing interval.', 'unitOfMeasure': 'ng*hr/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Ritonavir Maximum Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SLCO1B1 Group 1', 'description': 'SLCO1B1 \\*1A/\\*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}, {'id': 'OG001', 'title': 'SLCO1B1 Group 2', 'description': 'SLCO1B1 \\*1A/\\*1B or \\*1B/\\*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}, {'id': 'OG002', 'title': 'SLCO1B1 Group 3', 'description': 'Carriers of at least one SLCO1B1 \\*5, \\*15, or \\*17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}], 'classes': [{'categories': [{'measurements': [{'value': '844', 'spread': '708', 'groupId': 'OG000'}, {'value': '1143', 'spread': '649', 'groupId': 'OG001'}, {'value': '1279', 'spread': '748', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.15', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0,1, 2, 3, 4, 5, 6, 8, 12 hours post-dose', 'description': 'Cmax of ritonavir over a 12-hour dosing interval', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.'}, {'type': 'SECONDARY', 'title': 'Pravastatin Alone: Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SLCO1B1 Group 1', 'description': 'SLCO1B1 \\*1A/\\*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}, {'id': 'OG001', 'title': 'SLCO1B1 Group 2', 'description': 'SLCO1B1 \\*1A/\\*1B or \\*1B/\\*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.'}, {'id': 'OG002', 'title': 'SLCO1B1 Group 3', 'description': 'Carriers of at least one SLCO1B1 \\*5, \\*15, or \\*17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'spread': '25.2', 'groupId': 'OG000'}, {'value': '86.6', 'spread': '36.3', 'groupId': 'OG001'}, {'value': '123.4', 'spread': '80.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.22', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose', 'description': 'Dosing interval of 24 hours', 'unitOfMeasure': 'ng*h/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.'}, {'type': 'SECONDARY', 'title': 'Pravastatin Alone: Pravastatin Maximum Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SLCO1B1 Group 1', 'description': 'SLCO1B1 \\*1A/\\*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}, {'id': 'OG001', 'title': 'SLCO1B1 Group 2', 'description': 'SLCO1B1 \\*1A/\\*1B or \\*1B/\\*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.'}, {'id': 'OG002', 'title': 'SLCO1B1 Group 3', 'description': 'Carriers of at least one SLCO1B1 \\*5, \\*15, or \\*17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}], 'classes': [{'categories': [{'measurements': [{'value': '27.7', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '33.3', 'spread': '17.1', 'groupId': 'OG001'}, {'value': '46.2', 'spread': '38.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.67', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.'}, {'type': 'SECONDARY', 'title': 'Pravastatin + Darunavir/Ritonavir: Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SLCO1B1 Group 1', 'description': 'SLCO1B1 \\*1A/\\*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}, {'id': 'OG001', 'title': 'SLCO1B1 Group 2', 'description': 'SLCO1B1 \\*1A/\\*1B or \\*1B/\\*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.'}, {'id': 'OG002', 'title': 'SLCO1B1 Group 3', 'description': 'Carriers of at least one SLCO1B1 \\*5, \\*15, or \\*17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}], 'classes': [{'categories': [{'measurements': [{'value': '68.4', 'spread': '37.3', 'groupId': 'OG000'}, {'value': '106.8', 'spread': '47.9', 'groupId': 'OG001'}, {'value': '145.7', 'spread': '36.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose', 'description': 'Dosing interval of 24 hours', 'unitOfMeasure': 'ng*h/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.'}, {'type': 'SECONDARY', 'title': 'Pravastatin + Darunavir/Ritonavir: Pravastatin Maximum Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SLCO1B1 Group 1', 'description': 'SLCO1B1 \\*1A/\\*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}, {'id': 'OG001', 'title': 'SLCO1B1 Group 2', 'description': 'SLCO1B1 \\*1A/\\*1B or \\*1B/\\*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.'}, {'id': 'OG002', 'title': 'SLCO1B1 Group 3', 'description': 'Carriers of at least one SLCO1B1 \\*5, \\*15, or \\*17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}], 'classes': [{'categories': [{'measurements': [{'value': '30.1', 'spread': '19.7', 'groupId': 'OG000'}, {'value': '42.4', 'spread': '23.0', 'groupId': 'OG001'}, {'value': '52.8', 'spread': '11.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SLCO1B1 Group 1', 'description': 'SLCO1B1 \\*1A/\\*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}, {'id': 'FG001', 'title': 'SLCO1B1 Group 2', 'description': 'SLCO1B1 \\*1A/\\*1B or \\*1B/\\*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.'}, {'id': 'FG002', 'title': 'SLCO1B1 Group 3', 'description': 'Carriers of at least one SLCO1B1 \\*5, \\*15, or \\*17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Healthy volunteers were recruited from the Denver metro area between March 2008 and September 2009.', 'preAssignmentDetails': 'Participants were genetically screened for solute carrier organic anion transporter family, member 1B1 (SLCO1B1) diplotypes as follows: Group 1, \\*1A/\\*1A (reference diplotype); Group 2, \\*1A/\\*1B or \\*1B/\\*1B diplotypes; and Group 3, subjects with at least one copy of the \\*5, \\*15, or \\*17 haplotype.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'SLCO1B1 Group 1', 'description': 'SLCO1B1 \\*1A/\\*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}, {'id': 'BG001', 'title': 'SLCO1B1 Group 2', 'description': 'SLCO1B1 \\*1A/\\*1B or \\*1B/\\*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}, {'id': 'BG002', 'title': 'SLCO1B1 Group 3', 'description': 'Carriers of at least one SLCO1B1 \\*5, \\*15, or \\*17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36', 'spread': '11', 'groupId': 'BG000'}, {'value': '37', 'spread': '12', 'groupId': 'BG001'}, {'value': '39', 'spread': '11', 'groupId': 'BG002'}, {'value': '36', 'spread': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-20', 'studyFirstSubmitDate': '2008-02-28', 'resultsFirstSubmitDate': '2011-09-12', 'studyFirstSubmitQcDate': '2008-03-06', 'lastUpdatePostDateStruct': {'date': '2014-05-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-10-15', 'studyFirstPostDateStruct': {'date': '2008-03-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Darunavir Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval', 'timeFrame': '0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose', 'description': 'AUC of darunavir over a 12-hour dosing interval.'}, {'measure': 'Darunavir Maximum Plasma Concentration (Cmax)', 'timeFrame': '0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose', 'description': 'Cmax of darunavir over a 12-hour dosing interval'}, {'measure': 'Ritonavir Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval', 'timeFrame': '0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose', 'description': 'AUC of ritonavir over a 12-hour dosing interval.'}, {'measure': 'Ritonavir Maximum Plasma Concentration (Cmax)', 'timeFrame': '0,1, 2, 3, 4, 5, 6, 8, 12 hours post-dose', 'description': 'Cmax of ritonavir over a 12-hour dosing interval'}], 'primaryOutcomes': [{'measure': 'Relative Change in Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose', 'description': 'AUC of pravastatin when administered with darunavir/ritonavir divided by AUC of pravastatin when administered alone. The AUC was measured over a 24-hour dosing interval.'}, {'measure': 'Relative Change in Pravastatin Maximum Plasma Concentration (Cmax)', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose', 'description': 'Cmax of pravastatin when administered with darunavir/ritonavir divided by the Cmax of pravastatin when administered alone.'}], 'secondaryOutcomes': [{'measure': 'Pravastatin Alone: Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose', 'description': 'Dosing interval of 24 hours'}, {'measure': 'Pravastatin Alone: Pravastatin Maximum Plasma Concentration (Cmax)', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose'}, {'measure': 'Pravastatin + Darunavir/Ritonavir: Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose', 'description': 'Dosing interval of 24 hours'}, {'measure': 'Pravastatin + Darunavir/Ritonavir: Pravastatin Maximum Plasma Concentration (Cmax)', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'Pravastatin', 'Darunavir', 'Ritonavir', 'Genetic'], 'conditions': ['HIV Infections', 'Hyperlipidemia']}, 'descriptionModule': {'briefSummary': "Pravastatin (Pravachol) is approved by the Food and Drug Administration (FDA) and is used to treat high cholesterol. Darunavir (Prezista) and ritonavir (Norvir) are approved by the Food and Drug Administration (FDA) to treat HIV infection. When darunavir and ritonavir are given with pravastatin, they can increase the blood levels of pravastatin. The degree of this interaction varies from person to person. The way that darunavir and ritonavir interact with pravastatin may be affected by a person's genetic make-up. Genetic factors (or DNA) are those that people are born with and that make each person unique. Genetic differences are the reason why one person's body traits such as height and hair color are different from another person's body traits. Genetic differences can also affect the way a medication works in the body or the way two medications interact in the body. The purpose of this clinical study is to determine if a person's genetic make-up affects the way darunavir and ritonavir interact with pravastatin in the body."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, HIV-negative volunteers\n\nExclusion Criteria:\n\n* Currently active or chronic cardiovascular, hepatic, renal, pancreatic, gastrointestinal, neurologic, hematologic, psychiatric, metabolic, respiratory, inflammatory, or infectious disease\n* Chronic pancreatitis\n* History of rhabdomyolysis\n* History of statin-associated myopathy\n* Active malignancy\n* History of significant skin disease, food allergy, drug allergy, dermatitis, eczema, psoriasis\n* Pregnancy/breastfeeding\n* HIV positive and/or AIDS\n* serum creatinine grade 1 or greater (≥ 1.1 x upper limit of laboratory normal range \\[ULN\\]);\n* hemoglobin grade 1 or greater (≤ 10.9 g/dL);\n* platelet count grade 1 or greater (≤ 124.999 x 109/L);\n* absolute neutrophil count grade 1 or greater (≤ 1.3 x 109/L);\n* aspartate aminotransferase (AST) or alanine aminotransferase (ALT) grade 1 or greater (≥ 1.25 x ULN);\n* total bilirubin grade 1 or greater (≥ 1.1 x ULN)\n* serum lipase grade 1 or greater (≥ 1.1 x ULN)\n* serum amylase grade 1 or greater (≥ 1.1 x ULN)\n* any other laboratory abnormality of grade 2 or above'}, 'identificationModule': {'nctId': 'NCT00630734', 'briefTitle': 'Genetic Predictors of Variability in the Drug-drug Interaction Between Darunavir/Ritonavir and Pravastatin', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Genetic Predictors of Pharmacokinetic Variability in the Drug-drug Interaction Between Darunavir/Ritonavir and Pravastatin: the Role of SLCO1B1 Polymorphisms.', 'orgStudyIdInfo': {'id': '07-0272'}, 'secondaryIdInfos': [{'id': 'TMC114HIV4003'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SLCO1B1 Group 1', 'description': 'Participants with the SLCO1B1 \\*1A/\\*1A diplotype; Interventions: pravastatin 40 mg by mouth once daily on days 1-4, washout on days 5-11, darunavir 600 mg and ritonavir 100 mg by mouth twice daily on days 12-18, pravastatin 40 mg by mouth once daily on days 15-18.', 'interventionNames': ['Drug: Pravastatin', 'Drug: Darunavir', 'Drug: Ritonavir', 'Other: Washout']}, {'type': 'EXPERIMENTAL', 'label': 'SLCO1B1 Group 2', 'description': 'Participants with the SLCO1B1 \\*1A/\\*1B or \\*1B/\\*1B diplotype; Interventions: Pravastatin 40 mg by mouth once daily on days 1-4, washout on days 5-11, darunavir 600 mg and ritonavir 100 mg by mouth twice daily on days 12-18, pravastatin 40 mg by mouth once daily on days 15-18.', 'interventionNames': ['Drug: Pravastatin', 'Drug: Darunavir', 'Drug: Ritonavir', 'Other: Washout']}, {'type': 'EXPERIMENTAL', 'label': 'SLCO1B1 Group 3', 'description': 'Participants who carry at least one SLCO1B1 \\*5, \\*15, or \\*17 diplotype; Interventions: Pravastatin 40 mg by mouth once daily on days 1-4, washout on days 5-11, darunavir 600 mg and ritonavir 100 mg by mouth twice daily on days 12-18, pravastatin 40 mg by mouth once daily on days 15-18.', 'interventionNames': ['Drug: Pravastatin', 'Drug: Darunavir', 'Drug: Ritonavir', 'Other: Washout']}], 'interventions': [{'name': 'Pravastatin', 'type': 'DRUG', 'otherNames': ['Pravachol'], 'description': 'Pravastatin 40 mg by mouth daily on days 1-4', 'armGroupLabels': ['SLCO1B1 Group 1', 'SLCO1B1 Group 2', 'SLCO1B1 Group 3']}, {'name': 'Darunavir', 'type': 'DRUG', 'otherNames': ['Prezista'], 'description': 'Darunavir 600mg by mouth twice daily on days 12-18', 'armGroupLabels': ['SLCO1B1 Group 1', 'SLCO1B1 Group 2', 'SLCO1B1 Group 3']}, {'name': 'Ritonavir', 'type': 'DRUG', 'otherNames': ['Norvir'], 'description': 'Ritonavir 100mg by mouth twice daily on days 12-18', 'armGroupLabels': ['SLCO1B1 Group 1', 'SLCO1B1 Group 2', 'SLCO1B1 Group 3']}, {'name': 'Pravastatin', 'type': 'DRUG', 'otherNames': ['Pravachol'], 'description': 'Pravastatin 40 mg by mouth daily on days 15-18', 'armGroupLabels': ['SLCO1B1 Group 1', 'SLCO1B1 Group 2', 'SLCO1B1 Group 3']}, {'name': 'Washout', 'type': 'OTHER', 'description': 'Washout (no medication) on days 5-11.', 'armGroupLabels': ['SLCO1B1 Group 1', 'SLCO1B1 Group 2', 'SLCO1B1 Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Christina L Aquilante, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}