Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:47 PM
Study NCT ID:
NCT00717067
Status:
COMPLETED
Last Update Posted:
2010-11-19
First Post:
2008-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077592', 'term': 'Maraviroc'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'D019258', 'term': 'Saquinavir'}], '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': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011804', 'term': 'Quinolines'}]}}, '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': 'Healthy Subjects', 'description': 'Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mild Renal Impairment', 'description': 'Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Moderate Renal Impairment', 'description': 'Maraviroc 150 milligrams (mg) every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Healthy Subjects: Single Dose', 'description': 'Maraviroc 300 mg single dose.', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Severe Renal Impairment:', 'description': 'Maraviroc 300 mg single dose.', 'otherNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'ESRD: Dosing After Dialysis', 'description': 'Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'ESRD: Dosing Before Dialysis', 'description': 'Maraviroc 300 mg single dose three hours prior to start of hemodialysis.', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'sensation of foreign body', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'renal function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'renal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration Time-curve From Zero to the Last Measured Concentration (AUClast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Subjects: Multiple Dose', 'description': 'Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.'}, {'id': 'OG001', 'title': 'Mild Renal Impairment: Multiple Dose', 'description': 'Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment: Multiple Dose', 'description': 'Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.'}, {'id': 'OG003', 'title': 'Healthy Subjects: Single Dose', 'description': 'Maraviroc 300 mg single dose.'}, {'id': 'OG004', 'title': 'Severe Renal Impairment: Single Dose', 'description': 'Maraviroc 300 mg single dose.'}, {'id': 'OG005', 'title': 'ESRD: Single Dose; After Dialysis', 'description': 'Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.'}, {'id': 'OG006', 'title': 'ESRD: Single Dose; Before Dialysis', 'description': 'Maraviroc 300 mg single dose three hours prior to start of hemodialysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '7356.3', 'spread': '2313.45', 'groupId': 'OG000'}, {'value': '9502.1', 'spread': '3599.32', 'groupId': 'OG001'}, {'value': '6496.0', 'spread': '1795.89', 'groupId': 'OG002'}, {'value': '1320.7', 'spread': '988.66', 'groupId': 'OG003'}, {'value': '4255.5', 'spread': '2424.19', 'groupId': 'OG004'}, {'value': '2636.5', 'spread': '1123.34', 'groupId': 'OG005'}, {'value': '2770.1', 'spread': '1356.56', 'groupId': 'OG006'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of adjusted geometric means', 'ciPctValue': '90', 'paramValue': '129.17', 'ciLowerLimit': '92.16', 'ciUpperLimit': '181.04', 'groupDescription': 'Ratio (%) test (mild) / reference (normal). AUClast was calculated using the log-linear trapezoidal method.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'ratio of adjusted geometric means', 'ciPctValue': '90', 'paramValue': '88.31', 'ciLowerLimit': '61.97', 'ciUpperLimit': '125.83', 'groupDescription': 'Ratio (%) test (moderate) / reference (normal). AUClast was calculated using the log-linear trapezoidal method.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'ratio of adjusted geometric means', 'ciPctValue': '90', 'paramValue': '322.23', 'ciLowerLimit': '171.97', 'ciUpperLimit': '603.78', 'groupDescription': 'Ratio (%) test (severe) / reference (normal). AUClast was calculated using the log-linear trapezoidal method.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) measured in nanograms \\* hour divided by milliliters (ng\\*hr/mL).', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.'}, {'type': 'PRIMARY', 'title': 'AUCtau', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Subjects: Multiple Dose', 'description': 'Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.'}, {'id': 'OG001', 'title': 'Mild Renal Impairment: Multiple Dose', 'description': 'Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment: Multiple Dose', 'description': 'Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '5341.4', 'spread': '1498.27', 'groupId': 'OG000'}, {'value': '8118.7', 'spread': '2995.27', 'groupId': 'OG001'}, {'value': '6193.3', 'spread': '1762.41', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of adjusted geometric means', 'ciPctValue': '90', 'paramValue': '151.99', 'ciLowerLimit': '109.53', 'ciUpperLimit': '210.92', 'groupDescription': 'Ratio (%) test (mild) / reference (normal).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'ratio of adjusted geometric means', 'ciPctValue': '90', 'paramValue': '115.95', 'ciLowerLimit': '82.23', 'ciUpperLimit': '163.50', 'groupDescription': 'Ratio (%) test (moderate) / reference (normal).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.', 'description': 'AUCtau: area under the plasma concentration-time profile from time zero to the end of the dosing interval (tau); measured in nanograms \\* hours divided by milliliters (ng.hr/mL).', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest. AUCtau for end stage renal disease subjects was not determined.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Subjects: Multiple Dose', 'description': 'Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.'}, {'id': 'OG001', 'title': 'Mild Renal Impairment: Multiple Dose', 'description': 'Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment: Multiple Dose', 'description': 'Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.'}, {'id': 'OG003', 'title': 'Healthy Subjects: Single Dose', 'description': 'Maraviroc 300 mg single dose.'}, {'id': 'OG004', 'title': 'Severe Renal Impairment: Single Dose', 'description': 'Maraviroc 300 mg single dose.'}, {'id': 'OG005', 'title': 'ESRD: Single Dose; After Dialysis', 'description': 'Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.'}, {'id': 'OG006', 'title': 'ESRD: Single Dose; Before Dialysis', 'description': 'Maraviroc 300 mg single dose three hours prior to start of hemodialysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '950.91', 'spread': '220.368', 'groupId': 'OG000'}, {'value': '1150.74', 'spread': '392.167', 'groupId': 'OG001'}, {'value': '674.20', 'spread': '275.722', 'groupId': 'OG002'}, {'value': '335.60', 'spread': '393.024', 'groupId': 'OG003'}, {'value': '801.16', 'spread': '525.656', 'groupId': 'OG004'}, {'value': '576.7', 'spread': '339.27', 'groupId': 'OG005'}, {'value': '478.5', 'spread': '198.81', 'groupId': 'OG006'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of adjusted geometric means', 'ciPctValue': '90', 'paramValue': '121.01', 'ciLowerLimit': '83.15', 'ciUpperLimit': '176.13', 'groupDescription': 'Ratio (%) test (mild) / reference (normal).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'ratio of adjusted geometric means', 'ciPctValue': '90', 'paramValue': '70.90', 'ciLowerLimit': '47.83', 'ciUpperLimit': '105.10', 'groupDescription': 'Ratio (%) test (moderate) / reference (normal).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'ratio of adjusted geometric means', 'ciPctValue': '90', 'paramValue': '238.73', 'ciLowerLimit': '106.83', 'ciUpperLimit': '533.48', 'groupDescription': 'Ratio (%) test (severe) / reference (normal).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.', 'description': 'Maximum observed plasma concentration (Cmax) within the dosing interval; measured in nanograms per milliliter (ng/mL).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Plasma Protein Binding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Subjects: Multiple Dose', 'description': 'Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.'}, {'id': 'OG001', 'title': 'Mild Renal Impairment: Multiple Dose', 'description': 'Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment: Multiple Dose', 'description': 'Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.'}, {'id': 'OG003', 'title': 'Healthy Subjects: Single Dose', 'description': 'Maraviroc 300 mg single dose.'}, {'id': 'OG004', 'title': 'Severe Renal Impairment: Single Dose', 'description': 'Maraviroc 300 mg single dose.'}, {'id': 'OG005', 'title': 'ESRD', 'description': '(I) Maraviroc 300 mg single dose one hour following completion of morning hemodialysis, followed at least 1 week later by (II) Maraviroc 300 mg single dose three hours prior to start of hemodialysis.'}], 'classes': [{'title': 'minimum protein unbound MVC fraction', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000', 'lowerLimit': '14.6', 'upperLimit': '28.2'}, {'value': '15.3', 'groupId': 'OG001', 'lowerLimit': '15.3', 'upperLimit': '29.1'}, {'value': '18.1', 'groupId': 'OG002', 'lowerLimit': '18.1', 'upperLimit': '31.6'}, {'value': '14.6', 'groupId': 'OG003', 'lowerLimit': '19.2', 'upperLimit': '28.1'}, {'value': '19.2', 'groupId': 'OG004', 'lowerLimit': '18.2', 'upperLimit': '27.8'}, {'value': '18.2', 'groupId': 'OG005', 'lowerLimit': '18.2', 'upperLimit': '27.8'}]}]}, {'title': 'maximum protein unbound MVC fraction', 'categories': [{'measurements': [{'value': '26.6', 'groupId': 'OG000'}, {'value': '29.1', 'groupId': 'OG001'}, {'value': '31.6', 'groupId': 'OG002'}, {'value': '28.2', 'groupId': 'OG003'}, {'value': '28.1', 'groupId': 'OG004'}, {'value': '27.8', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours post-dose; normal Day -3 and Day 7; mild moderate: Day 7; severe and ESRD: Day 1', 'description': 'Percent protein binding (protein unbound maraviroc (MVC) fraction \\[percent free\\]) was determined by rapid equilibrium dialysis. Percent free = 100 - percent bound.', 'unitOfMeasure': 'percent free', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Area Under the Time Curve From 0 to Infinity (AUCinf)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Subjects: Single Dose', 'description': 'Maraviroc 300 mg single dose.'}, {'id': 'OG001', 'title': 'Severe Renal Impairment: Single Dose', 'description': 'Maraviroc 300 mg single dose.'}, {'id': 'OG002', 'title': 'ESRD: Single Dose; After Dialysis', 'description': 'Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.'}, {'id': 'OG003', 'title': 'ESRD: Single Dose; Before Dialysis', 'description': 'Maraviroc 300 mg single dose three hours prior to start of hemodialysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '1348.4', 'spread': '986.65', 'groupId': 'OG000'}, {'value': '4367.7', 'spread': '2518.78', 'groupId': 'OG001'}, {'value': '2677.4', 'spread': '1149.85', 'groupId': 'OG002'}, {'value': '2805.5', 'spread': '1374.71', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of adjusted geometric means', 'ciPctValue': '90', 'paramValue': '323.91', 'ciLowerLimit': '174.32', 'ciUpperLimit': '601.88', 'groupDescription': 'Ratio (%) test (severe) / reference (normal).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72', 'description': 'Area under the plasma concentration-time profile from time zero to the time infinate in subjects who received single dose treatment; measured in nanograms \\* hour divided by millilters (ng\\*hr/mL).', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest. AUC infinity was not determined for subjects in the multiple dose treatment groups.'}, {'type': 'SECONDARY', 'title': 'Time of First Occurrence (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Subjects: Multiple Dose', 'description': 'Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.'}, {'id': 'OG001', 'title': 'Mild Renal Impairment: Multiple Dose', 'description': 'Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment: Multiple Dose', 'description': 'Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.'}, {'id': 'OG003', 'title': 'Healthy Subjects: Single Dose', 'description': 'Maraviroc 300 mg single dose.'}, {'id': 'OG004', 'title': 'Severe Renal Impairment: Single Dose', 'description': 'Maraviroc 300 mg single dose.'}, {'id': 'OG005', 'title': 'ESRD: Single Dose; After Dialysis', 'description': 'Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.'}, {'id': 'OG006', 'title': 'ESRD: Single Dose; Before Dialysis', 'description': 'Maraviroc 300 mg single dose three hours prior to start of hemodialysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.000', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '2.00'}, {'value': '1.500', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '4.00'}, {'value': '2.000', 'groupId': 'OG002', 'lowerLimit': '0.50', 'upperLimit': '4.02'}, {'value': '2.500', 'groupId': 'OG003', 'lowerLimit': '0.50', 'upperLimit': '4.02'}, {'value': '2.500', 'groupId': 'OG004', 'lowerLimit': '0.50', 'upperLimit': '4.00'}, {'value': '3.000', 'groupId': 'OG005', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '2.000', 'groupId': 'OG006', 'lowerLimit': '0.50', 'upperLimit': '4.17'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.', 'description': 'Time (hours) of first occurrence (Tmax); time after dosing when Cmax (maximum plasma concentration) occured.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Half-life (t1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Subjects: Multiple Dose', 'description': 'Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.'}, {'id': 'OG001', 'title': 'Mild Renal Impairment: Multiple Dose', 'description': 'Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment: Multiple Dose', 'description': 'Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.'}, {'id': 'OG003', 'title': 'Healthy Subjects: Single Dose', 'description': 'Maraviroc 300 mg single dose.'}, {'id': 'OG004', 'title': 'Severe Renal Impairment: Single Dose', 'description': 'Maraviroc 300 mg single dose.'}, {'id': 'OG005', 'title': 'ESRD: Single Dose; After Dialysis', 'description': 'Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.'}, {'id': 'OG006', 'title': 'ESRD: Single Dose; Before Dialysis', 'description': 'Maraviroc 300 mg single dose three hours prior to start of hemodialysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.22', 'spread': '1.166', 'groupId': 'OG000'}, {'value': '16.84', 'spread': '5.568', 'groupId': 'OG001'}, {'value': '16.99', 'spread': '3.141', 'groupId': 'OG002'}, {'value': '14.36', 'spread': '4.030', 'groupId': 'OG003'}, {'value': '17.29', 'spread': '4.171', 'groupId': 'OG004'}, {'value': '15.03', 'spread': '3.329', 'groupId': 'OG005'}, {'value': '13.86', 'spread': '1.051', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.', 'description': 'Elimination half-life (t1/2) measured in hours: time required for half the quantity of maraviroc to be metabolized or eliminated by normal biological processes.', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Renal Clearance (CLR) in Subjects With Normal, Mild, Moderate and Severe Renal Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Subjects: Multiple Dose', 'description': 'Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.'}, {'id': 'OG001', 'title': 'Mild Renal Impairment: Multiple Dose', 'description': 'Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment: Multiple Dose', 'description': 'Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.'}, {'id': 'OG003', 'title': 'Healthy Subjects: Single Dose', 'description': 'Maraviroc 300 mg single dose.'}, {'id': 'OG004', 'title': 'Severe Renal Impairment: Single Dose', 'description': 'Maraviroc 300 mg single dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '105.7', 'spread': '56.00', 'groupId': 'OG000'}, {'value': '77.2', 'spread': '36.71', 'groupId': 'OG001'}, {'value': '62.5', 'spread': '12.57', 'groupId': 'OG002'}, {'value': '110.0', 'spread': '38.67', 'groupId': 'OG003'}, {'value': '26.6', 'spread': '18.84', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Hour 0 (prior to MVC dosing [single dose] or prior to last MVC dose [multiple dose]) to 72 hours post-dose ; hours 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.', 'description': 'Renal clearance (CLR) measured in milliliters per minute (mL/min).', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Derivation of Renal Clearance in Subjects With Normal, Mild, Moderate and Severe Renal Function: Ae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Subjects: Multiple Dose', 'description': 'Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.'}, {'id': 'OG001', 'title': 'Mild Renal Impairment: Multiple Dose', 'description': 'Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment: Multiple Dose', 'description': 'Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.'}, {'id': 'OG003', 'title': 'Healthy Subjects: Single Dose', 'description': 'Maraviroc 300 mg single dose.'}, {'id': 'OG004', 'title': 'Severe Renal Impairment: Single Dose', 'description': 'Maraviroc 300 mg single dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.6', 'spread': '22.45', 'groupId': 'OG000'}, {'value': '39.1', 'spread': '11.23', 'groupId': 'OG001'}, {'value': '24.9', 'spread': '8.88', 'groupId': 'OG002'}, {'value': '10.8', 'spread': '7.41', 'groupId': 'OG003'}, {'value': '8.4', 'spread': '6.35', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Hour 0 (prior to MVC dosing [single dose] or prior to last MVC dose [multiple dose]) to 72 hours post-dose ; hours 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.', 'description': 'Ae: amount of drug excreted unchanged in the urine; measured in milligrams (mg).', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Hemodialysis Clearance of Maraviroc (MVC) in Subjects With End Stage Renal Disease (ESRD) Undergoing Hemodialysis: CLdD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ESRD: Single Dose; Before Dialysis', 'description': 'Maraviroc 300 mg single dose three hours prior to start of hemodialysis'}], 'classes': [{'categories': [{'measurements': [{'value': '36.42', 'spread': '12.710', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before dialysis', 'description': 'CLdD: dialysate clearance before dialysis; measured in milliliters per minute.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum Increase and Decrease in Supine Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Subjects: Multiple Dose', 'description': 'Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.'}, {'id': 'OG001', 'title': 'Mild Renal Impairment: Multiple Dose', 'description': 'Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment: Multiple Dose', 'description': 'Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.'}, {'id': 'OG003', 'title': 'Healthy Subjects: Single Dose', 'description': 'Maraviroc 300 mg single dose.'}, {'id': 'OG004', 'title': 'Severe Renal Impairment: Single Dose', 'description': 'Maraviroc 300 mg single dose.'}, {'id': 'OG005', 'title': 'ESRD: Single Dose; After Dialysis', 'description': 'Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.'}, {'id': 'OG006', 'title': 'ESRD: Single Dose; Before Dialysis', 'description': 'Maraviroc 300 mg single dose three hours prior to start of hemodialysis.'}], 'classes': [{'title': 'BL Supine Systolic Blood Pressure (BP) <90 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Maximum Increase from BL: Supine Systolic BP≥ 30', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Maximum Decrease from BL: Supine Systolic BP ≥ 30', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'BL Supine Diastolic Blood Pressure (BP) <50 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Maximum Increase from BL: Supine Diastolic BP≥ 20', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Maximun Decrease from BL: Supine Diastolic BP ≥20', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Normal renal function: screening, Day -3 to Day -1; normal, mild and moderate RI: Day 7 to Day 10 and follow-up; severe RI: Day 1 to Day 4 and follow-up; ESRD: Day 1, Day 4, and follow-up', 'description': 'Number of subjects with absolute values of supine systolic blood pressure (BP) measured in millimeters of mercury (mm/Hg), range: \\<90 mmHg; and supine diastolic blood pressure, range: \\<50 mmHg. Number of subjects with a maximum increase and decrease from Baseline in supine systolic BP ≥ 30 mmHg. Number of subjects with a maximum increase and decrease from Baseline in supine diastolic BP ≥ 20 mmHg.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: all subjects who received study medication. BL: Baseline.'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Pulse Rate < 40 and > 120 Beats Per Minute', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Subjects: Multiple Dose', 'description': 'Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.'}, {'id': 'OG001', 'title': 'Mild Renal Impairment: Multiple Dose', 'description': 'Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment: Multiple Dose', 'description': 'Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.'}, {'id': 'OG003', 'title': 'Healthy Subjects: Single Dose', 'description': 'Maraviroc 300 mg single dose.'}, {'id': 'OG004', 'title': 'Severe Renal Impairment: Single Dose', 'description': 'Maraviroc 300 mg single dose.'}, {'id': 'OG005', 'title': 'ESRD: Single Dose; After Dialysis', 'description': 'Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.'}, {'id': 'OG006', 'title': 'ESRD: Single Dose; Before Dialysis', 'description': 'Maraviroc 300 mg single dose three hours prior to start of hemodialysis.'}], 'classes': [{'title': 'Supine Pulse Rate <40 BPM', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Supine Pulse Rate >120 BPM', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Normal renal function: screening, Day -3 to Day -1; normal, mild and moderate RI: Day 7 to Day 10 and follow-up; severe RI: Day 1 to Day 4 and follow-up; ESRD: Day 1, Day 4, and follow-up', 'description': 'Number of subjects with pulse rate \\< 40 beats per minute (BPM), number of subjects with pulse rate \\> 120 BPM.', 'unitOfMeasure': 'bpm', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: all subjects who received study medication.'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum EGC QTC, QTCB and QTCF Intervals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Subjects: Multiple Dose', 'description': 'Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.'}, {'id': 'OG001', 'title': 'Mild Renal Impairment: Multiple Dose', 'description': 'Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.'}, {'id': 'OG002', 'title': 'Moderate Renal Impairment: Multiple Dose', 'description': 'Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.'}, {'id': 'OG003', 'title': 'Healthy Subjects: Single Dose', 'description': 'Maraviroc 300 mg single dose.'}, {'id': 'OG004', 'title': 'Severe Renal Impairment: Single Dose', 'description': 'Maraviroc 300 mg single dose.'}, {'id': 'OG005', 'title': 'ESRD: Single Dose; After Dialysis', 'description': 'Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.'}, {'id': 'OG006', 'title': 'ESRD: Single Dose; Before Dialysis', 'description': 'Maraviroc 300 mg single dose three hours prior to start of hemodialysis.'}], 'classes': [{'title': 'Maximum QTC Interval: 450 to < 480 msec', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Maximum QTC Interval: 480 to < 500 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Maximum QTC Interval: > 500 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Maximum QTCB Interval: 450 to < 480 msec', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Maximum QTCB Interval: 480 to < 500 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Maximum QTCB Interval: > 500 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Maximum QTCF Interval: 450 to 480 msec', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Maximum QTCF Interval: 480 to < 500 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Maximum QTCF Interval: > 500 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Max. QTC Interval Increase from BL: change ≥30 <60', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'QTC Interval Increase from BL: change ≥ 60', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Normal renal function: screening, Day -3 and Day -1; normal renal function, mild and moderate RI: Day 7 to Day 9 and follow-up; severe RI: screening, Day 1, Day 3, Day 4, and follow-up; ESRD: screening, Day 1, Day 3, Day 4, and follow-up', 'description': "Single 12-lead ECG: number of subjects with maximum QTC interval, maximum QTCB interval (Bazett's correction), and maximum QTCF interval (Friderica's correction) measured in milliseconds (msec); range: 450 to \\<480 msec, 480 to \\<500 msec, and \\>500 msec. Maximum QTC interval increase from Baseline; citeria: change = ≥ 30 msec to \\< 60 msec, and change = ≥ 60 msec.", 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: all subjects who received study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Subjects', 'description': '(I) Maraviroc single 300 mg dose, followed 4 days later by (II) Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.'}, {'id': 'FG001', 'title': 'Mild Renal Impairment', 'description': 'Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.'}, {'id': 'FG002', 'title': 'Moderate Renal Impairment', 'description': 'Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.'}, {'id': 'FG003', 'title': 'Severe Renal Impairment', 'description': 'Maraviroc 300 mg single dose.'}, {'id': 'FG004', 'title': 'ESRD: Single Dose', 'description': '(I) Maraviroc single dose one hour following completion of morning hemodialysis, followed at least 1 week later by (II) Maraviroc single dose three hours prior to start of hemodialysis.'}], 'periods': [{'title': 'Part 1a: Normal/Mild/Moderate Group', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Part 1b: Severe Renal Impairment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Part 2: End Stage Renal Disease', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Two centers took part in this study between 15 July 2008 and 21 November 2008.', 'preAssignmentDetails': 'Subjects were enrolled into treatment groups (healthy subjects, mild, moderate, severe renal impairment, or end stage renal impairment on hemodialysis) based on creatinine clearance results obtained closest to the dosing date at screening as determined by the Cockcroft-Gault equation (with the exception of subjects undergoing hemodialysis).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Subjects', 'description': 'Subjects with Normal Renal Function (Creatinine Clearance \\> 80mL/min)'}, {'id': 'BG001', 'title': 'Mild Renal Impairment', 'description': 'Subjects with Mild Renal Impairment (Creatinine Clearance \\>50 and ≤80 mL/min)'}, {'id': 'BG002', 'title': 'Moderate Renal Impairment', 'description': 'Subjects with Moderate Renal Impairment (Creatinine Clearance ≥30 and ≤50 mL/min)'}, {'id': 'BG003', 'title': 'Severe Renal Impairment', 'description': 'Subjects with Severe Renal Impairment (Creatinine Clearance \\<30 mL/min)'}, {'id': 'BG004', 'title': 'ESRD on Hemodialysis', 'description': 'Subjects with End Stage Renal Disease Requiring Regular Hemodialysis 3 Times a Week for at Least 6 Weeks Prior to Screening (Creatinine Clearance \\<30 mL/min)'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18 - 44 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}, {'title': '45 - 64 years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}]}]}, {'title': '>= 65 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'years'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-10', 'studyFirstSubmitDate': '2008-07-15', 'resultsFirstSubmitDate': '2009-11-16', 'studyFirstSubmitQcDate': '2008-07-15', 'lastUpdatePostDateStruct': {'date': '2010-11-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-11-16', 'studyFirstPostDateStruct': {'date': '2008-07-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Plasma Concentration Time-curve From Zero to the Last Measured Concentration (AUClast)', 'timeFrame': 'Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) measured in nanograms \\* hour divided by milliliters (ng\\*hr/mL).'}, {'measure': 'AUCtau', 'timeFrame': 'Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.', 'description': 'AUCtau: area under the plasma concentration-time profile from time zero to the end of the dosing interval (tau); measured in nanograms \\* hours divided by milliliters (ng.hr/mL).'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': 'Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.', 'description': 'Maximum observed plasma concentration (Cmax) within the dosing interval; measured in nanograms per milliliter (ng/mL).'}], 'secondaryOutcomes': [{'measure': 'Plasma Protein Binding', 'timeFrame': '2 hours post-dose; normal Day -3 and Day 7; mild moderate: Day 7; severe and ESRD: Day 1', 'description': 'Percent protein binding (protein unbound maraviroc (MVC) fraction \\[percent free\\]) was determined by rapid equilibrium dialysis. Percent free = 100 - percent bound.'}, {'measure': 'Area Under the Time Curve From 0 to Infinity (AUCinf)', 'timeFrame': 'Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72', 'description': 'Area under the plasma concentration-time profile from time zero to the time infinate in subjects who received single dose treatment; measured in nanograms \\* hour divided by millilters (ng\\*hr/mL).'}, {'measure': 'Time of First Occurrence (Tmax)', 'timeFrame': 'Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.', 'description': 'Time (hours) of first occurrence (Tmax); time after dosing when Cmax (maximum plasma concentration) occured.'}, {'measure': 'Half-life (t1/2)', 'timeFrame': 'Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.', 'description': 'Elimination half-life (t1/2) measured in hours: time required for half the quantity of maraviroc to be metabolized or eliminated by normal biological processes.'}, {'measure': 'Renal Clearance (CLR) in Subjects With Normal, Mild, Moderate and Severe Renal Function', 'timeFrame': 'Hour 0 (prior to MVC dosing [single dose] or prior to last MVC dose [multiple dose]) to 72 hours post-dose ; hours 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.', 'description': 'Renal clearance (CLR) measured in milliliters per minute (mL/min).'}, {'measure': 'Derivation of Renal Clearance in Subjects With Normal, Mild, Moderate and Severe Renal Function: Ae', 'timeFrame': 'Hour 0 (prior to MVC dosing [single dose] or prior to last MVC dose [multiple dose]) to 72 hours post-dose ; hours 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.', 'description': 'Ae: amount of drug excreted unchanged in the urine; measured in milligrams (mg).'}, {'measure': 'Hemodialysis Clearance of Maraviroc (MVC) in Subjects With End Stage Renal Disease (ESRD) Undergoing Hemodialysis: CLdD', 'timeFrame': 'Before dialysis', 'description': 'CLdD: dialysate clearance before dialysis; measured in milliliters per minute.'}, {'measure': 'Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum Increase and Decrease in Supine Blood Pressure', 'timeFrame': 'Normal renal function: screening, Day -3 to Day -1; normal, mild and moderate RI: Day 7 to Day 10 and follow-up; severe RI: Day 1 to Day 4 and follow-up; ESRD: Day 1, Day 4, and follow-up', 'description': 'Number of subjects with absolute values of supine systolic blood pressure (BP) measured in millimeters of mercury (mm/Hg), range: \\<90 mmHg; and supine diastolic blood pressure, range: \\<50 mmHg. Number of subjects with a maximum increase and decrease from Baseline in supine systolic BP ≥ 30 mmHg. Number of subjects with a maximum increase and decrease from Baseline in supine diastolic BP ≥ 20 mmHg.'}, {'measure': 'Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Pulse Rate < 40 and > 120 Beats Per Minute', 'timeFrame': 'Normal renal function: screening, Day -3 to Day -1; normal, mild and moderate RI: Day 7 to Day 10 and follow-up; severe RI: Day 1 to Day 4 and follow-up; ESRD: Day 1, Day 4, and follow-up', 'description': 'Number of subjects with pulse rate \\< 40 beats per minute (BPM), number of subjects with pulse rate \\> 120 BPM.'}, {'measure': 'Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum EGC QTC, QTCB and QTCF Intervals', 'timeFrame': 'Normal renal function: screening, Day -3 and Day -1; normal renal function, mild and moderate RI: Day 7 to Day 9 and follow-up; severe RI: screening, Day 1, Day 3, Day 4, and follow-up; ESRD: screening, Day 1, Day 3, Day 4, and follow-up', 'description': "Single 12-lead ECG: number of subjects with maximum QTC interval, maximum QTCB interval (Bazett's correction), and maximum QTCF interval (Friderica's correction) measured in milliseconds (msec); range: 450 to \\<480 msec, 480 to \\<500 msec, and \\>500 msec. Maximum QTC interval increase from Baseline; citeria: change = ≥ 30 msec to \\< 60 msec, and change = ≥ 60 msec."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['maraviroc, pharmacokinetics, renal impairment'], 'conditions': ['Human Immunodeficiency Virus (HIV) Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4001075&StudyName=Pharmacokinetics%2C%20Safety%20And%20Toleration%20Of%0AMaraviroc%20Administered%20To%20Subjects%20With%20Various%20Degrees%20Of%20Renal%20Impaired%20And%20Normal%20Renal%20Fu', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess whether a dosing adjustment is needed in patients with renal impairment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable Renal Function defined as ≤20% (25% for normal renal function) difference between 2 measurements of serum creatinine obtained on 2 occasions separated by at least 2 weeks.\n* Body Mass Index (BMI) of approximately 18 to 40 kg/m2 inclusive.\n* Total body weight \\>50 kg (110 lbs).\n* Male or female subjects between the ages of 18 and 85 years.\n\nExclusion Criteria:\n\n* Subjects with acute renal disease and/or history of renal transplant.\n* Supine BP at Screening ≥160 mm Hg systolic or ≥95 mm Hg diastolic.\n* Supine BP at Screening ≤80 mm Hg systolic or ≤40 mm Hg diastolic.'}, 'identificationModule': {'nctId': 'NCT00717067', 'briefTitle': 'Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'An Open-Label, Parallel Group, Single And Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function', 'orgStudyIdInfo': {'id': 'A4001075'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Subjects', 'description': 'Subjects with Normal Renal Function (Creatinine Clearance \\> 80mL/min) (I) Maraviroc single dose, followed by (II) Maraviroc + Saquinavir/Ritonavir', 'interventionNames': ['Drug: Maraviroc', 'Drug: Ritonavir', 'Drug: Saquinavir']}, {'type': 'EXPERIMENTAL', 'label': 'Mild Renal Impairment', 'description': 'Subjects with Mild Renal Impairment (Creatinine Clearance \\>50 and ≤80 mL/min)', 'interventionNames': ['Drug: Maraviroc', 'Drug: Ritonavir', 'Drug: Saquinavir']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate Renal Impairment', 'description': 'Subjects with Moderate Renal Impairment (Creatinine Clearance ≥30 and ≤50 mL/min)', 'interventionNames': ['Drug: Maraviroc', 'Drug: Ritonavir', 'Drug: Saquinavir']}, {'type': 'EXPERIMENTAL', 'label': 'Severe Renal Impairment', 'description': 'Subjects with Severe Renal Impairment (Creatinine Clearance \\<30 mL/min)', 'interventionNames': ['Drug: Maraviroc']}, {'type': 'EXPERIMENTAL', 'label': 'ESRD on Hemodialysis', 'description': 'Subjects with End Stage Renal Impairment receiving Hemodialysis(Creatinine Clearance \\<30 mL/min) (I) Maraviroc single dose one hour following completion of hemodialysis, followed by (II) Maraviroc single dose three hours prior to start of hemodialysis', 'interventionNames': ['Drug: Maraviroc']}], 'interventions': [{'name': 'Maraviroc', 'type': 'DRUG', 'description': 'Maraviroc 300 mg (150 mg x 2 tablets) x single dose', 'armGroupLabels': ['Healthy Subjects']}, {'name': 'Maraviroc', 'type': 'DRUG', 'description': 'Maraviroc 150 mg tablet twice daily x 7 days', 'armGroupLabels': ['Healthy Subjects']}, {'name': 'Ritonavir', 'type': 'DRUG', 'description': 'Ritonavir 100 mg capsule twice daily x 7 days', 'armGroupLabels': ['Healthy Subjects']}, {'name': 'Saquinavir', 'type': 'DRUG', 'description': 'Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days', 'armGroupLabels': ['Healthy Subjects']}, {'name': 'Maraviroc', 'type': 'DRUG', 'description': 'Maraviroc 150 mg tablet once daily x 7 days', 'armGroupLabels': ['Mild Renal Impairment']}, {'name': 'Ritonavir', 'type': 'DRUG', 'description': 'Ritonavir 100 mg capsule twice daily x 7 days', 'armGroupLabels': ['Mild Renal Impairment']}, {'name': 'Saquinavir', 'type': 'DRUG', 'description': 'Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days', 'armGroupLabels': ['Mild Renal Impairment']}, {'name': 'Maraviroc', 'type': 'DRUG', 'description': 'Maraviroc 150 mg tablet once every 48 hours x 7 days', 'armGroupLabels': ['Moderate Renal Impairment']}, {'name': 'Ritonavir', 'type': 'DRUG', 'description': 'Ritonavir 100 mg capsule twice daily x 7 days', 'armGroupLabels': ['Moderate Renal Impairment']}, {'name': 'Saquinavir', 'type': 'DRUG', 'description': 'Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days', 'armGroupLabels': ['Moderate Renal Impairment']}, {'name': 'Maraviroc', 'type': 'DRUG', 'description': 'Maraviroc 300 mg (150 mg x 2 tablets) x single dose', 'armGroupLabels': ['Severe Renal Impairment']}, {'name': 'Maraviroc', 'type': 'DRUG', 'description': 'Maraviroc 300 mg (150 mg x 2 tablets) x single dose one hour following completion of hemodialysis', 'armGroupLabels': ['ESRD on Hemodialysis']}, {'name': 'Maraviroc', 'type': 'DRUG', 'description': 'Maraviroc 300 mg (150 mg x 2 tablets) x single dose three hours prior to start of hemodialysis', 'armGroupLabels': ['ESRD on Hemodialysis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '81241', 'city': 'München', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}], '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': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}