Viewing Study NCT00296504

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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 9:17 PM

Ignite Modification Date: 2025-12-25 @ 7:05 PM

Study NCT ID: NCT00296504

Status: COMPLETED

Last Update Posted: 2013-04-19

First Post: 2006-02-24

Is NOT Gene Therapy: False

Has Adverse Events: True

Brief Title: A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Australia', 'Austria', 'Belgium', 'Canada', 'Costa Rica', 'Germany', 'Hungary', 'Israel', 'Latvia', 'Panama', 'Poland', 'Puerto Rico', 'South Africa', 'Switzerland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C426859', 'term': 'fosamprenavir'}, {'id': 'D019438', 'term': 'Ritonavir'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'ViiV Healthcare'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'FPV Population (APV30001)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)', 'otherNumAtRisk': 119, 'otherNumAffected': 115, 'seriousNumAtRisk': 119, 'seriousNumAffected': 33}, {'id': 'EG001', 'title': 'NFV Population (APV30001)', 'description': 'FPV +/- RTV + background regimen in participants who had received NFV in APV30001', 'otherNumAtRisk': 18, 'otherNumAffected': 16, 'seriousNumAtRisk': 18, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'FPV Population (APV30002)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)', 'otherNumAtRisk': 221, 'otherNumAffected': 209, 'seriousNumAtRisk': 221, 'seriousNumAffected': 62}, {'id': 'EG003', 'title': 'NFV Population (APV30002)', 'description': 'FPV +/- RTV + background regimen in participants who had received NFV in APV30002', 'otherNumAtRisk': 54, 'otherNumAffected': 53, 'seriousNumAtRisk': 54, 'seriousNumAffected': 7}, {'id': 'EG004', 'title': 'FPV/RTV QD Population (APV30003)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)', 'otherNumAtRisk': 73, 'otherNumAffected': 68, 'seriousNumAtRisk': 73, 'seriousNumAffected': 20}, {'id': 'EG005', 'title': 'FPV/RTV BID Population (APV30003)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003', 'otherNumAtRisk': 78, 'otherNumAffected': 73, 'seriousNumAtRisk': 78, 'seriousNumAffected': 14}, {'id': 'EG006', 'title': 'PI-Naïve Population (Other Studies)', 'description': 'FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study', 'otherNumAtRisk': 104, 'otherNumAffected': 76, 'seriousNumAtRisk': 104, 'seriousNumAffected': 7}, {'id': 'EG007', 'title': 'PI-Experienced Population (Other Studies)', 'description': 'FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study', 'otherNumAtRisk': 86, 'otherNumAffected': 40, 'seriousNumAtRisk': 86, 'seriousNumAffected': 13}, {'id': 'EG008', 'title': 'Final Analysis Population (APV30005)', 'description': 'FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006', 'otherNumAtRisk': 111, 'otherNumAffected': 82, 'seriousNumAtRisk': 111, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 131}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 27}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 37}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 16}, {'groupId': 'EG007', 'numAtRisk': 86, 'numAffected': 14}, {'groupId': 'EG008', 'numAtRisk': 111, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 100}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 21}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 21}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 9}, {'groupId': 'EG007', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 111, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 69}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 30}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 22}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 19}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 21}, {'groupId': 'EG007', 'numAtRisk': 86, 'numAffected': 8}, {'groupId': 'EG008', 'numAtRisk': 111, 'numAffected': 32}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 48}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 19}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 16}, {'groupId': 'EG007', 'numAtRisk': 86, 'numAffected': 14}, {'groupId': 'EG008', 'numAtRisk': 111, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 41}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 111, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 59}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 28}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 10}, {'groupId': 'EG007', 'numAtRisk': 86, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 111, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 56}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 13}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 86, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 111, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 54}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 17}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 86, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 111, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 53}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 17}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 86, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 111, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 86, 'numAffected': 8}, {'groupId': 'EG008', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 18}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 10}, {'groupId': 'EG007', 'numAtRisk': 86, 'numAffected': 9}, {'groupId': 'EG008', 'numAtRisk': 111, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 86, 'numAffected': 8}, {'groupId': 'EG008', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 9}, {'groupId': 'EG007', 'numAtRisk': 86, 'numAffected': 10}, {'groupId': 'EG008', 'numAtRisk': 111, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 15}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 9}, {'groupId': 'EG007', 'numAtRisk': 86, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 111, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 111, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 86, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 111, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 86, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anogenital warts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 86, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 86, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 86, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 111, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 37}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 9}, {'groupId': 'EG007', 'numAtRisk': 86, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 111, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 111, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 37}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 17}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 9}, {'groupId': 'EG007', 'numAtRisk': 86, 'numAffected': 9}, {'groupId': 'EG008', 'numAtRisk': 111, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 73, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 78, 'numAffected': 13}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 86, 'numAffected': 5}, 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'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Any Adverse Event (AE): Interim Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '221', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '73', 'groupId': 'OG004'}, {'value': '78', 'groupId': 'OG005'}, {'value': '104', 'groupId': 'OG006'}, {'value': '86', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV Population (APV30001)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)'}, {'id': 'OG001', 'title': 'NFV Population (APV30001)', 'description': 'FPV +/- RTV + background regimen in participants who had received NFV in APV30001'}, {'id': 'OG002', 'title': 'FPV Population (APV30002)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)'}, {'id': 'OG003', 'title': 'NFV Population (APV30002)', 'description': 'FPV +/- RTV + background regimen in participants who had received NFV in APV30002'}, {'id': 'OG004', 'title': 'FPV/RTV QD Population (APV30003)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)'}, {'id': 'OG005', 'title': 'FPV/RTV BID Population (APV30003)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003'}, {'id': 'OG006', 'title': 'PI-Naïve Population (Other Studies)', 'description': 'FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study'}, {'id': 'OG007', 'title': 'PI-Experienced Population (Other Studies)', 'description': 'FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study'}], 'classes': [{'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}, {'value': '75', 'groupId': 'OG005'}, {'value': '95', 'groupId': 'OG006'}, {'value': '68', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) up to 31 January 2006 (up to Week 264)', 'description': 'An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Any Adverse Event (AE): Final Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Final Analysis Population (APV30005)', 'description': 'FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006'}], 'classes': [{'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post January 2006; for up to 241 weeks', 'description': 'An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who remained in the study after January 31, 2006.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '159', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}, {'value': '65', 'groupId': 'OG005'}, {'value': '77', 'groupId': 'OG006'}, {'value': '59', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV Population (APV30001)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)'}, {'id': 'OG001', 'title': 'NFV Population (APV30001)', 'description': 'FPV +/- RTV + background regimen in participants who had received NFV in APV30001'}, {'id': 'OG002', 'title': 'FPV Population (APV30002)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)'}, {'id': 'OG003', 'title': 'NFV Population (APV30002)', 'description': 'FPV +/- RTV + background regimen in participants who had received NFV in APV30002'}, {'id': 'OG004', 'title': 'FPV/RTV QD Population (APV30003)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)'}, {'id': 'OG005', 'title': 'FPV/RTV BID Population (APV30003)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003'}, {'id': 'OG006', 'title': 'PI-Naïve Population (Other Studies)', 'description': 'FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study'}, {'id': 'OG007', 'title': 'PI-Experienced Population (Other Studies)', 'description': 'FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study'}], 'classes': [{'title': 'Tri.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '-34', 'upperLimit': '42'}, {'value': '-41', 'groupId': 'OG001', 'lowerLimit': '-63', 'upperLimit': '-20'}, {'value': '51', 'groupId': 'OG002', 'lowerLimit': '14', 'upperLimit': '118'}, {'value': '20', 'groupId': 'OG003', 'lowerLimit': '-19', 'upperLimit': '57'}, {'value': '9', 'groupId': 'OG004', 'lowerLimit': '-25', 'upperLimit': '44'}, {'value': '14', 'groupId': 'OG005', 'lowerLimit': '-69', 'upperLimit': '66'}, {'value': '5', 'groupId': 'OG006', 'lowerLimit': '-27', 'upperLimit': '58'}, {'value': '-54', 'groupId': 'OG007', 'lowerLimit': '-96', 'upperLimit': '-12'}]}]}, {'title': 'Tri.; W 96, n=92, 13, 132 36, 47, 52, 67, 44', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '-26', 'upperLimit': '43'}, {'value': '-48', 'groupId': 'OG001', 'lowerLimit': '-101', 'upperLimit': '8'}, {'value': '47', 'groupId': 'OG002', 'lowerLimit': '10', 'upperLimit': '101'}, {'value': '15', 'groupId': 'OG003', 'lowerLimit': '-22', 'upperLimit': '48'}, {'value': '16', 'groupId': 'OG004', 'lowerLimit': '-51', 'upperLimit': '40'}, {'value': '34', 'groupId': 'OG005', 'lowerLimit': '-21', 'upperLimit': '118'}, {'value': '-5', 'groupId': 'OG006', 'lowerLimit': '-35', 'upperLimit': '42'}, {'value': '7', 'groupId': 'OG007', 'lowerLimit': '-3', 'upperLimit': '41'}]}]}, {'title': 'Tri.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '-24', 'upperLimit': '59'}, {'value': '-33', 'groupId': 'OG001', 'lowerLimit': '-77', 'upperLimit': '0'}, {'value': '43', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '121'}, {'value': '-4', 'groupId': 'OG003', 'lowerLimit': '-24', 'upperLimit': '69'}, {'value': '13', 'groupId': 'OG004', 'lowerLimit': '-27', 'upperLimit': '49'}, {'value': '22', 'groupId': 'OG005', 'lowerLimit': '-39', 'upperLimit': '96'}, {'value': '-4', 'groupId': 'OG006', 'lowerLimit': '-50', 'upperLimit': '50'}, {'value': '-73', 'groupId': 'OG007', 'lowerLimit': '-283', 'upperLimit': '2'}]}]}, {'title': 'Tri.; W 132, n=82, 12, 128, 32, 40, 44, 61, 40', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '-27', 'upperLimit': '46'}, {'value': '-2', 'groupId': 'OG001', 'lowerLimit': '-66', 'upperLimit': '6'}, {'value': '47', 'groupId': 'OG002', 'lowerLimit': '-0', 'upperLimit': '101'}, {'value': '18', 'groupId': 'OG003', 'lowerLimit': '-21', 'upperLimit': '58'}, {'value': '14', 'groupId': 'OG004', 'lowerLimit': '-63', 'upperLimit': '65'}, {'value': '18', 'groupId': 'OG005', 'lowerLimit': '-61', 'upperLimit': '63'}, {'value': '6', 'groupId': 'OG006', 'lowerLimit': '-48', 'upperLimit': '32'}, {'value': '-129', 'groupId': 'OG007', 'lowerLimit': '-343', 'upperLimit': '75'}]}]}, {'title': 'Tri.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '-27', 'upperLimit': '66'}, {'value': '-12', 'groupId': 'OG001', 'lowerLimit': '-58', 'upperLimit': '25'}, {'value': '27', 'groupId': 'OG002', 'lowerLimit': '-19', 'upperLimit': '86'}, {'value': '4', 'groupId': 'OG003', 'lowerLimit': '-16', 'upperLimit': '49'}, {'value': '29', 'groupId': 'OG004', 'lowerLimit': '-55', 'upperLimit': '59'}, {'value': '42', 'groupId': 'OG005', 'lowerLimit': '-25', 'upperLimit': '177'}, {'value': '5', 'groupId': 'OG006', 'lowerLimit': '-32', 'upperLimit': '27'}, {'value': '-167', 'groupId': 'OG007', 'lowerLimit': '-238', 'upperLimit': '-10'}]}]}, {'title': 'Tri.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '-38', 'upperLimit': '43'}, {'value': '-41', 'groupId': 'OG001', 'lowerLimit': '-89', 'upperLimit': '7'}, {'value': '37', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '87'}, {'value': '18', 'groupId': 'OG003', 'lowerLimit': '-16', 'upperLimit': '81'}, {'value': '13', 'groupId': 'OG004', 'lowerLimit': '-27', 'upperLimit': '63'}, {'value': '8', 'groupId': 'OG005', 'lowerLimit': '-95', 'upperLimit': '112'}, {'value': '-2', 'groupId': 'OG006', 'lowerLimit': '-38', 'upperLimit': '20'}, {'value': '-170', 'groupId': 'OG007', 'lowerLimit': '-267', 'upperLimit': '-56'}]}]}, {'title': 'Tri.; W 204, n=73, 12, 113, 23, 20, 26, 61, 40', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '-26', 'upperLimit': '44'}, {'value': '-36', 'groupId': 'OG001', 'lowerLimit': '-88', 'upperLimit': '-14'}, {'value': '43', 'groupId': 'OG002', 'lowerLimit': '8', 'upperLimit': '87'}, {'value': '12', 'groupId': 'OG003', 'lowerLimit': '-18', 'upperLimit': '54'}, {'value': '4', 'groupId': 'OG004', 'lowerLimit': '-45', 'upperLimit': '28'}, {'value': '49', 'groupId': 'OG005', 'lowerLimit': '-26', 'upperLimit': '161'}, {'value': '12', 'groupId': 'OG006', 'lowerLimit': '-4', 'upperLimit': '33'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Tri.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '-35', 'upperLimit': '49'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '39', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '97'}, {'value': '98', 'groupId': 'OG003', 'lowerLimit': '34', 'upperLimit': '163'}, {'value': '-7', 'groupId': 'OG004', 'lowerLimit': '-165', 'upperLimit': '57'}, {'value': '66', 'groupId': 'OG005', 'lowerLimit': '-33', 'upperLimit': '160'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Chol.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '70'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '-32', 'upperLimit': '13'}, {'value': '53', 'groupId': 'OG002', 'lowerLimit': '26', 'upperLimit': '77'}, {'value': '10', 'groupId': 'OG003', 'lowerLimit': '-6', 'upperLimit': '26'}, {'value': '14', 'groupId': 'OG004', 'lowerLimit': '-9', 'upperLimit': '34'}, {'value': '13', 'groupId': 'OG005', 'lowerLimit': '-12', 'upperLimit': '33'}, {'value': '8', 'groupId': 'OG006', 'lowerLimit': '-13', 'upperLimit': '22'}, {'value': '22', 'groupId': 'OG007', 'lowerLimit': '-14', 'upperLimit': '44'}]}]}, {'title': 'Chol.; W 96, n=92, 13, 132, 36, 47, 52, 67, 44', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '58'}, {'value': '-3', 'groupId': 'OG001', 'lowerLimit': '-16', 'upperLimit': '25'}, {'value': '46', 'groupId': 'OG002', 'lowerLimit': '21', 'upperLimit': '68'}, {'value': '8', 'groupId': 'OG003', 'lowerLimit': '-14', 'upperLimit': '23'}, {'value': '12', 'groupId': 'OG004', 'lowerLimit': '-15', 'upperLimit': '26'}, {'value': '10', 'groupId': 'OG005', 'lowerLimit': '-13', 'upperLimit': '38'}, {'value': '13', 'groupId': 'OG006', 'lowerLimit': '-9', 'upperLimit': '32'}, {'value': '19', 'groupId': 'OG007', 'lowerLimit': '1', 'upperLimit': '57'}]}]}, {'title': 'Chol.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '64'}, {'value': '-9', 'groupId': 'OG001', 'lowerLimit': '-17', 'upperLimit': '9'}, {'value': '50', 'groupId': 'OG002', 'lowerLimit': '23', 'upperLimit': '73'}, {'value': '9', 'groupId': 'OG003', 'lowerLimit': '-15', 'upperLimit': '23'}, {'value': '11', 'groupId': 'OG004', 'lowerLimit': '-16', 'upperLimit': '25'}, {'value': '22', 'groupId': 'OG005', 'lowerLimit': '-8', 'upperLimit': '31'}, {'value': '13', 'groupId': 'OG006', 'lowerLimit': '-10', 'upperLimit': '30'}, {'value': '32', 'groupId': 'OG007', 'lowerLimit': '12', 'upperLimit': '44'}]}]}, {'title': 'Chol.; W 132, n=82, 13, 128, 32, 40, 44, 61, 40', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '72'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '-23', 'upperLimit': '32'}, {'value': '47', 'groupId': 'OG002', 'lowerLimit': '18', 'upperLimit': '82'}, {'value': '13', 'groupId': 'OG003', 'lowerLimit': '-10', 'upperLimit': '38'}, {'value': '14', 'groupId': 'OG004', 'lowerLimit': '-13', 'upperLimit': '30'}, {'value': '-4', 'groupId': 'OG005', 'lowerLimit': '-24', 'upperLimit': '30'}, {'value': '2', 'groupId': 'OG006', 'lowerLimit': '-12', 'upperLimit': '27'}, {'value': '12', 'groupId': 'OG007', 'lowerLimit': '-38', 'upperLimit': '41'}]}]}, {'title': 'Chol.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '78'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '-18', 'upperLimit': '38'}, {'value': '47', 'groupId': 'OG002', 'lowerLimit': '18', 'upperLimit': '76'}, {'value': '21', 'groupId': 'OG003', 'lowerLimit': '-4', 'upperLimit': '60'}, {'value': '18', 'groupId': 'OG004', 'lowerLimit': '-15', 'upperLimit': '34'}, {'value': '9', 'groupId': 'OG005', 'lowerLimit': '-22', 'upperLimit': '31'}, {'value': '6', 'groupId': 'OG006', 'lowerLimit': '-1', 'upperLimit': '23'}, {'value': '28', 'groupId': 'OG007', 'lowerLimit': '19', 'upperLimit': '52'}]}]}, {'title': 'Chol.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '73'}, {'value': '-4', 'groupId': 'OG001', 'lowerLimit': '-16', 'upperLimit': '28'}, {'value': '53', 'groupId': 'OG002', 'lowerLimit': '24', 'upperLimit': '78'}, {'value': '19', 'groupId': 'OG003', 'lowerLimit': '-4', 'upperLimit': '40'}, {'value': '3', 'groupId': 'OG004', 'lowerLimit': '-8', 'upperLimit': '34'}, {'value': '9', 'groupId': 'OG005', 'lowerLimit': '-19', 'upperLimit': '27'}, {'value': '5', 'groupId': 'OG006', 'lowerLimit': '-1', 'upperLimit': '17'}, {'value': '43', 'groupId': 'OG007', 'lowerLimit': '1', 'upperLimit': '61'}]}]}, {'title': 'Chol.; W 204, n=73, 12, 113, 23, 20, 26, 61, 40', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '76'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '-32', 'upperLimit': '22'}, {'value': '53', 'groupId': 'OG002', 'lowerLimit': '22', 'upperLimit': '80'}, {'value': '22', 'groupId': 'OG003', 'lowerLimit': '-18', 'upperLimit': '61'}, {'value': '-3', 'groupId': 'OG004', 'lowerLimit': '-38', 'upperLimit': '18'}, {'value': '11', 'groupId': 'OG005', 'lowerLimit': '-9', 'upperLimit': '36'}, {'value': '-5', 'groupId': 'OG006', 'lowerLimit': '-12', 'upperLimit': '14'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Chol.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '79'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '47', 'groupId': 'OG002', 'lowerLimit': '24', 'upperLimit': '70'}, {'value': '30', 'groupId': 'OG003', 'lowerLimit': '24', 'upperLimit': '35'}, {'value': '-65', 'groupId': 'OG004', 'lowerLimit': '-82', 'upperLimit': '-48'}, {'value': '28', 'groupId': 'OG005', 'lowerLimit': '-8', 'upperLimit': '34'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'HDL Chol.; W 48, n=54, 14, 159, 38, 61, 65, 77 59,', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '18'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-5', 'upperLimit': '5'}, {'value': '8', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '15'}, {'value': '3', 'groupId': 'OG003', 'lowerLimit': '-5', 'upperLimit': '8'}, {'value': '6', 'groupId': 'OG004', 'lowerLimit': '-1', 'upperLimit': '10'}, {'value': '2', 'groupId': 'OG005', 'lowerLimit': '-4', 'upperLimit': '11'}, {'value': '3', 'groupId': 'OG006', 'lowerLimit': '-3', 'upperLimit': '8'}, {'value': '8', 'groupId': 'OG007', 'lowerLimit': '5', 'upperLimit': '13'}]}]}, {'title': 'HDL Chol.; W 96, n=92, 13, 132, 36, 47, 52, 67, 44', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '18'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '16'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '19'}, {'value': '4', 'groupId': 'OG003', 'lowerLimit': '-2', 'upperLimit': '10'}, {'value': '6', 'groupId': 'OG004', 'lowerLimit': '-1', 'upperLimit': '12'}, {'value': '2', 'groupId': 'OG005', 'lowerLimit': '-6', 'upperLimit': '10'}, {'value': '4', 'groupId': 'OG006', 'lowerLimit': '-3', 'upperLimit': '8'}, {'value': '5', 'groupId': 'OG007', 'lowerLimit': '4', 'upperLimit': '13'}]}]}, {'title': 'HDL Chol.; W 120, n=84, 14, 137, 33, 45, 49, 61,40', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '17'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '11'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '3', 'upperLimit': '20'}, {'value': '7', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '15'}, {'value': '8', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '13'}, {'value': '4', 'groupId': 'OG005', 'lowerLimit': '-2', 'upperLimit': '9'}, {'value': '5', 'groupId': 'OG006', 'lowerLimit': '-6', 'upperLimit': '11'}, {'value': '10', 'groupId': 'OG007', 'lowerLimit': '9', 'upperLimit': '20'}]}]}, {'title': 'HDL Chol.; W 132, n=82, 13, 128, 32, 40, 44, 61,40', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '21'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '13'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '7', 'upperLimit': '20'}, {'value': '9', 'groupId': 'OG003', 'lowerLimit': '3', 'upperLimit': '17'}, {'value': '6', 'groupId': 'OG004', 'lowerLimit': '3', 'upperLimit': '15'}, {'value': '5', 'groupId': 'OG005', 'lowerLimit': '-2', 'upperLimit': '12'}, {'value': '3', 'groupId': 'OG006', 'lowerLimit': '-6', 'upperLimit': '11'}, {'value': '16', 'groupId': 'OG007', 'lowerLimit': '12', 'upperLimit': '22'}]}]}, {'title': 'HDL Chol.; W 168, n=71, 14, 123, 31, 31, 40, 0, 0', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '24'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '21'}, {'value': '17', 'groupId': 'OG002', 'lowerLimit': '6', 'upperLimit': '24'}, {'value': '12', 'groupId': 'OG003', 'lowerLimit': '3', 'upperLimit': '17'}, {'value': '8', 'groupId': 'OG004', 'lowerLimit': '-1', 'upperLimit': '15'}, {'value': '2', 'groupId': 'OG005', 'lowerLimit': '-5', 'upperLimit': '8'}, {'value': '10', 'groupId': 'OG006', 'lowerLimit': '3', 'upperLimit': '14'}, {'value': '5', 'groupId': 'OG007', 'lowerLimit': '4', 'upperLimit': '24'}]}]}, {'title': 'HDL Chol.; W 180, n=73, 12, 114, 30, 33, 38, 61,40', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '24'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '16'}, {'value': '15', 'groupId': 'OG002', 'lowerLimit': '7', 'upperLimit': '25'}, {'value': '10', 'groupId': 'OG003', 'lowerLimit': '3', 'upperLimit': '17'}, {'value': '7', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '12'}, {'value': '4', 'groupId': 'OG005', 'lowerLimit': '-4', 'upperLimit': '9'}, {'value': '12', 'comment': 'Only one participant was analyzed in this arm at this time point.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '18', 'groupId': 'OG007', 'lowerLimit': '15', 'upperLimit': '26'}]}]}, {'title': 'HDL Chol.; W 204, n=73, 10, 113, 23, 20, 26, 61,40', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '26'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '16'}, {'value': '17', 'groupId': 'OG002', 'lowerLimit': '10', 'upperLimit': '26'}, {'value': '15', 'groupId': 'OG003', 'lowerLimit': '2', 'upperLimit': '22'}, {'value': '6', 'groupId': 'OG004', 'lowerLimit': '-0.19', 'upperLimit': '15'}, {'value': '2', 'groupId': 'OG005', 'lowerLimit': '-7', 'upperLimit': '12'}, {'value': '3', 'comment': 'Only one participant was analyzed in this arm at this time point.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'HDL Chol.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '26'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '17', 'groupId': 'OG002', 'lowerLimit': '7', 'upperLimit': '25'}, {'value': '4', 'groupId': 'OG003', 'lowerLimit': '3', 'upperLimit': '6'}, {'value': '3', 'groupId': 'OG004', 'lowerLimit': '-5', 'upperLimit': '4'}, {'value': '6', 'groupId': 'OG005', 'lowerLimit': '-3', 'upperLimit': '12'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'LDL Chol.; W 48, n=50, 13, 145, 35, 53, 50, 67, 48', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '53'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '-11', 'upperLimit': '16'}, {'value': '30', 'groupId': 'OG002', 'lowerLimit': '10', 'upperLimit': '53'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '-8', 'upperLimit': '19'}, {'value': '2', 'groupId': 'OG004', 'lowerLimit': '-24', 'upperLimit': '21'}, {'value': '-1', 'groupId': 'OG005', 'lowerLimit': '-15', 'upperLimit': '24'}, {'value': '3', 'groupId': 'OG006', 'lowerLimit': '-13', 'upperLimit': '21'}, {'value': '17', 'groupId': 'OG007', 'lowerLimit': '10', 'upperLimit': '29'}]}]}, {'title': 'LDL Chol.; W 96, n=87, 12, 121, 34, 43, 43, 63, 37', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '40'}, {'value': '-2', 'groupId': 'OG001', 'lowerLimit': '-10', 'upperLimit': '12'}, {'value': '21', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '45'}, {'value': '1', 'groupId': 'OG003', 'lowerLimit': '-20', 'upperLimit': '17'}, {'value': '3', 'groupId': 'OG004', 'lowerLimit': '-20', 'upperLimit': '15'}, {'value': '0', 'groupId': 'OG005', 'lowerLimit': '-18', 'upperLimit': '27'}, {'value': '7', 'groupId': 'OG006', 'lowerLimit': '-12', 'upperLimit': '25'}, {'value': '15', 'groupId': 'OG007', 'lowerLimit': '13', 'upperLimit': '45'}]}]}, {'title': 'LDL Chol.; W 120, n=78, 13, 120, 29, 40, 39, 61,40', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '44'}, {'value': '-4', 'groupId': 'OG001', 'lowerLimit': '-11', 'upperLimit': '8'}, {'value': '21', 'groupId': 'OG002', 'lowerLimit': '3', 'upperLimit': '41'}, {'value': '-2', 'groupId': 'OG003', 'lowerLimit': '-21', 'upperLimit': '11'}, {'value': '-6', 'groupId': 'OG004', 'lowerLimit': '-20', 'upperLimit': '8'}, {'value': '12', 'groupId': 'OG005', 'lowerLimit': '-19', 'upperLimit': '25'}, {'value': '3', 'groupId': 'OG006', 'lowerLimit': '-9', 'upperLimit': '22'}, {'value': '38', 'groupId': 'OG007', 'lowerLimit': '22', 'upperLimit': '61'}]}]}, {'title': 'LDL Chol.; W 132, n=78, 12, 117, 29, 36, 37, 58,34', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '42'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '-20', 'upperLimit': '18'}, {'value': '24', 'groupId': 'OG002', 'lowerLimit': '-3', 'upperLimit': '43'}, {'value': '4', 'groupId': 'OG003', 'lowerLimit': '-25', 'upperLimit': '19'}, {'value': '-4', 'groupId': 'OG004', 'lowerLimit': '-27', 'upperLimit': '20'}, {'value': '-2', 'groupId': 'OG005', 'lowerLimit': '-20', 'upperLimit': '17'}, {'value': '0', 'groupId': 'OG006', 'lowerLimit': '-22', 'upperLimit': '20'}, {'value': '14', 'groupId': 'OG007', 'lowerLimit': '14', 'upperLimit': '15'}]}]}, {'title': 'LDL Chol.; W 168, n=63, 13, 115, 30, 28, 34, 0, 0', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '54'}, {'value': '-5', 'groupId': 'OG001', 'lowerLimit': '-17', 'upperLimit': '20'}, {'value': '18', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '43'}, {'value': '5', 'groupId': 'OG003', 'lowerLimit': '-17', 'upperLimit': '23'}, {'value': '-3', 'groupId': 'OG004', 'lowerLimit': '-25', 'upperLimit': '11'}, {'value': '-6', 'groupId': 'OG005', 'lowerLimit': '-27', 'upperLimit': '22'}, {'value': '-1', 'groupId': 'OG006', 'lowerLimit': '-8', 'upperLimit': '2'}, {'value': '48', 'groupId': 'OG007', 'lowerLimit': '24', 'upperLimit': '72'}]}]}, {'title': 'LDL Chol.; W 180, n=67, 11, 111, 27, 29, 30, 61,40', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '56'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '-8', 'upperLimit': '18'}, {'value': '23', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '49'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '-18', 'upperLimit': '14'}, {'value': '-2', 'groupId': 'OG004', 'lowerLimit': '-16', 'upperLimit': '17'}, {'value': '4', 'groupId': 'OG005', 'lowerLimit': '-20', 'upperLimit': '18'}, {'value': '-7', 'comment': 'Only one participant was analyzed in this arm at this time point.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '54', 'groupId': 'OG007', 'lowerLimit': '48', 'upperLimit': '60'}]}]}, {'title': 'LDL Chol.; W 204, n=70, 11, 105, 22, 19, 19, 61,40', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '51'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '-24', 'upperLimit': '19'}, {'value': '22', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '46'}, {'value': '13', 'groupId': 'OG003', 'lowerLimit': '-18', 'upperLimit': '40'}, {'value': '-14', 'groupId': 'OG004', 'lowerLimit': '-32', 'upperLimit': '12'}, {'value': '1', 'groupId': 'OG005', 'lowerLimit': '-26', 'upperLimit': '25'}, {'value': '-45', 'comment': 'Only one participant was analyzed in this arm at this time point.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'LDL Chol.; W 216, n=69, 0, 105, 2, 4, 10, 61, 40', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '55'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '21', 'groupId': 'OG002', 'lowerLimit': '-3', 'upperLimit': '45'}, {'value': '5', 'groupId': 'OG003', 'lowerLimit': '-15', 'upperLimit': '26'}, {'value': '-39', 'groupId': 'OG004', 'lowerLimit': '-66', 'upperLimit': '-23'}, {'value': '3', 'groupId': 'OG005', 'lowerLimit': '-42', 'upperLimit': '45'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'FBG; W 48, n=54, 14, 158, 36, 61, 65, 77, 59', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '16'}, {'value': '-2', 'groupId': 'OG001', 'lowerLimit': '-4', 'upperLimit': '2'}, {'value': '3.6', 'groupId': 'OG002', 'lowerLimit': '-5', 'upperLimit': '11'}, {'value': '-4', 'groupId': 'OG003', 'lowerLimit': '-9', 'upperLimit': '6'}, {'value': '2', 'groupId': 'OG004', 'lowerLimit': '-4', 'upperLimit': '11'}, {'value': '7', 'groupId': 'OG005', 'lowerLimit': '-2', 'upperLimit': '13'}, {'value': '0', 'groupId': 'OG006', 'lowerLimit': '-9', 'upperLimit': '11'}, {'value': '0', 'groupId': 'OG007', 'lowerLimit': '-16', 'upperLimit': '7'}]}]}, {'title': 'FBG; W 96, n=92, 13, 132, 34, 47, 52, 67, 44', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '-4', 'upperLimit': '11'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-5', 'upperLimit': '4'}, {'value': '1.8', 'groupId': 'OG002', 'lowerLimit': '-4', 'upperLimit': '11'}, {'value': '-5', 'groupId': 'OG003', 'lowerLimit': '-11', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '-9', 'upperLimit': '9'}, {'value': '4', 'groupId': 'OG005', 'lowerLimit': '-5', 'upperLimit': '14'}, {'value': '0', 'groupId': 'OG006', 'lowerLimit': '-11', 'upperLimit': '7'}, {'value': '-5', 'groupId': 'OG007', 'lowerLimit': '-11', 'upperLimit': '5'}]}]}, {'title': 'FBG; W 120, n=84, 14, 136, 31, 44, 48, 61, 40', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '14'}, {'value': '-2', 'groupId': 'OG001', 'lowerLimit': '-7', 'upperLimit': '2'}, {'value': '1.8', 'groupId': 'OG002', 'lowerLimit': '-5', 'upperLimit': '11'}, {'value': '-9', 'groupId': 'OG003', 'lowerLimit': '-16', 'upperLimit': '-4'}, {'value': '1', 'groupId': 'OG004', 'lowerLimit': '-6', 'upperLimit': '7'}, {'value': '2', 'groupId': 'OG005', 'lowerLimit': '-10', 'upperLimit': '12'}, {'value': '0', 'groupId': 'OG006', 'lowerLimit': '-7', 'upperLimit': '11'}, {'value': '-2', 'groupId': 'OG007', 'lowerLimit': '-11', 'upperLimit': '2'}]}]}, {'title': 'FBG; W 132, n=82, 13, 128, 30, 40, 44, 61, 40', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-5', 'upperLimit': '13'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-5', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '-7', 'upperLimit': '11'}, {'value': '-4', 'groupId': 'OG003', 'lowerLimit': '-5', 'upperLimit': '4'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '-9', 'upperLimit': '5'}, {'value': '0', 'groupId': 'OG005', 'lowerLimit': '-10', 'upperLimit': '7'}, {'value': '7', 'groupId': 'OG006', 'lowerLimit': '-2', 'upperLimit': '16'}, {'value': '-14', 'groupId': 'OG007', 'lowerLimit': '-21', 'upperLimit': '-8'}]}]}, {'title': 'FBG; W 168, n=71, 14, 123, 29, 31, 40, 0, 0', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '-5', 'upperLimit': '11'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '-4', 'upperLimit': '4'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '-9', 'upperLimit': '9'}, {'value': '-2', 'groupId': 'OG003', 'lowerLimit': '-7', 'upperLimit': '5'}, {'value': '2', 'groupId': 'OG004', 'lowerLimit': '-4', 'upperLimit': '7'}, {'value': '-3', 'groupId': 'OG005', 'lowerLimit': '-14', 'upperLimit': '9'}, {'value': '21', 'groupId': 'OG006', 'lowerLimit': '13', 'upperLimit': '24'}, {'value': '0', 'groupId': 'OG007', 'lowerLimit': '-2', 'upperLimit': '2'}]}]}, {'title': 'FBG; W 180, n=73, 12, 112, 28, 33, 37, 61, 40', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '-7', 'upperLimit': '11'}, {'value': '-0.9', 'groupId': 'OG001', 'lowerLimit': '-4', 'upperLimit': '1'}, {'value': '2.7', 'groupId': 'OG002', 'lowerLimit': '-5', 'upperLimit': '9.0'}, {'value': '-1.8', 'groupId': 'OG003', 'lowerLimit': '-7', 'upperLimit': '7'}, {'value': '2', 'groupId': 'OG004', 'lowerLimit': '-4', 'upperLimit': '11'}, {'value': '2', 'groupId': 'OG005', 'lowerLimit': '-6', 'upperLimit': '7'}, {'value': '20', 'groupId': 'OG006', 'lowerLimit': '14', 'upperLimit': '29'}, {'value': '-1', 'groupId': 'OG007', 'lowerLimit': '-5', 'upperLimit': '3'}]}]}, {'title': 'FBG; W 204, n=73, 12, 115, 23, 20, 26, 61, 40', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '-5', 'upperLimit': '9'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '-8', 'upperLimit': '9'}, {'value': '1.8', 'groupId': 'OG002', 'lowerLimit': '-5', 'upperLimit': '11'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '-5', 'upperLimit': '5'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '-7', 'upperLimit': '7'}, {'value': '5', 'groupId': 'OG005', 'lowerLimit': '-5', 'upperLimit': '16'}, {'value': '21', 'groupId': 'OG006', 'lowerLimit': '14', 'upperLimit': '25'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'FBG; W 216, n=75, 0, 110, 2, 5, 11, 61, 40', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-5', 'upperLimit': '7'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.4', 'groupId': 'OG002', 'lowerLimit': '-2', 'upperLimit': '13'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '-2', 'upperLimit': '5'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '-7', 'upperLimit': '16'}, {'value': '11', 'groupId': 'OG005', 'lowerLimit': '-2', 'upperLimit': '20'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1) and Weeks 48, 96, 120, 132, 168, 180, 204, and 216', 'description': 'Fasting blood samples of participants were collected for the assessment of triglycerides (Tri.), cholesterol (Chol.), high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG). Change from Baseline at Weeks (W) 48, 96, 120, 132, 168, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).', 'unitOfMeasure': 'milligrams per deciliter (mg/dl)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005. Only those participants contributing data at the indicated time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Final Analysis Population (APV30005)', 'description': 'FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006'}], 'classes': [{'title': 'Triglycerides; Week 120, n=14', 'categories': [{'measurements': [{'value': '237', 'groupId': 'OG000', 'lowerLimit': '187', 'upperLimit': '372'}]}]}, {'title': 'Triglycerides; Week 180, n=14', 'categories': [{'measurements': [{'value': '248', 'groupId': 'OG000', 'lowerLimit': '193', 'upperLimit': '312'}]}]}, {'title': 'Triglycerides; Week 204, n=106', 'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000', 'lowerLimit': '95', 'upperLimit': '204'}]}]}, {'title': 'Triglycerides; Week 216, n=102', 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000', 'lowerLimit': '92', 'upperLimit': '192'}]}]}, {'title': 'Triglycerides; Week 432, n=40', 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000', 'lowerLimit': '76', 'upperLimit': '182'}]}]}, {'title': 'Cholesterol; Week 120, n=14', 'categories': [{'measurements': [{'value': '202', 'groupId': 'OG000', 'lowerLimit': '183', 'upperLimit': '284'}]}]}, {'title': 'Cholesterol; Week 180, n=14', 'categories': [{'measurements': [{'value': '206', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '226'}]}]}, {'title': 'Cholesterol; Week 204, n=106', 'categories': [{'measurements': [{'value': '201', 'groupId': 'OG000', 'lowerLimit': '166', 'upperLimit': '232'}]}]}, {'title': 'Cholesterol; Week 216, n=102', 'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000', 'lowerLimit': '169', 'upperLimit': '239'}]}]}, {'title': 'Cholesterol; Week 432, n=40', 'categories': [{'measurements': [{'value': '192', 'groupId': 'OG000', 'lowerLimit': '168', 'upperLimit': '233'}]}]}, {'title': 'HDL Cholesterol; Week 120, n=14', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '34', 'upperLimit': '45'}]}]}, {'title': 'HDL Cholesterol; Week 180, n=14', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000', 'lowerLimit': '34', 'upperLimit': '47'}]}]}, {'title': 'HDL Cholesterol; Week 204, n=106', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000', 'lowerLimit': '42', 'upperLimit': '61'}]}]}, {'title': 'HDL Cholesterol; Week 216, n=102', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000', 'lowerLimit': '44', 'upperLimit': '62'}]}]}, {'title': 'HDL Cholesterol; Week 432, n=40', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000', 'lowerLimit': '44', 'upperLimit': '57'}]}]}, {'title': 'LDL Cholesterol; Week 120, n=14', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '34', 'upperLimit': '45'}]}]}, {'title': 'LDL Cholesterol; Week 180, n=14', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '34', 'upperLimit': '48'}]}]}, {'title': 'LDL Cholesterol; Week 204, n=106', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000', 'lowerLimit': '42', 'upperLimit': '61'}]}]}, {'title': 'LDL Cholesterol; Week 216, n=102', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000', 'lowerLimit': '44', 'upperLimit': '62'}]}]}, {'title': 'LDL Cholesterol; Week 432, n=40', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000', 'lowerLimit': '44', 'upperLimit': '57'}]}]}, {'title': 'FBG; Week 120, n=14', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '79', 'upperLimit': '97'}]}]}, {'title': 'FBG; Week 180, n=14', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '85', 'upperLimit': '92'}]}]}, {'title': 'FBG; Week 204, n=106', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000', 'lowerLimit': '81', 'upperLimit': '97'}]}]}, {'title': 'FBG; Week 216, n=104', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '81', 'upperLimit': '97'}]}]}, {'title': 'FBG Cholesterol; Week 432, n=40', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000', 'lowerLimit': '83', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 120, 180, 204, 216, and 432', 'description': 'Fasting blood samples of participants were collected for the assessment of triglycerides, cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG).', 'unitOfMeasure': 'milligrams per deciliter (mg/dl)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '159', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV Population (APV30001)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)'}, {'id': 'OG001', 'title': 'NFV Population (APV30001)', 'description': 'FPV +/- RTV + background regimen in participants who had received NFV in APV30001'}, {'id': 'OG002', 'title': 'FPV Population (APV30002)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)'}, {'id': 'OG003', 'title': 'NFV Population (APV30002)', 'description': 'FPV +/- RTV + background regimen in participants who had received NFV in APV30002'}], 'classes': [{'title': 'Week 48, n=54, 14, 159, 38', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '0.8'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '0.6'}, {'value': '0.4', 'groupId': 'OG002', 'lowerLimit': '-0.3', 'upperLimit': '1.2'}, {'value': '0.1', 'groupId': 'OG003', 'lowerLimit': '-0.3', 'upperLimit': '0.5'}]}]}, {'title': 'Week 120, n=84, 14, 137, 33', 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '0.4'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-1.1', 'upperLimit': '-0.2'}, {'value': '-0.1', 'groupId': 'OG002', 'lowerLimit': '-0.8', 'upperLimit': '0.7'}, {'value': '-0.2', 'groupId': 'OG003', 'lowerLimit': '-0.7', 'upperLimit': '0.1'}]}]}, {'title': 'Week 180, n=73, 12, 114, 30', 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '0.2'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-1.6', 'upperLimit': '0.1'}, {'value': '-0.3', 'groupId': 'OG002', 'lowerLimit': '-1.0', 'upperLimit': '0.4'}, {'value': '-0.3', 'groupId': 'OG003', 'lowerLimit': '-1.3', 'upperLimit': '0'}]}]}, {'title': 'Week 204, n=73, 12, 113, 23', 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '0.1'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-1.7', 'upperLimit': '0.1'}, {'value': '-0.4', 'groupId': 'OG002', 'lowerLimit': '-1.0', 'upperLimit': '0.1'}, {'value': '-0.4', 'groupId': 'OG003', 'lowerLimit': '-0.9', 'upperLimit': '0.23'}]}]}, {'title': 'Week 216, n=76, 0, 111, 2', 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '0.2'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-0.5', 'groupId': 'OG002', 'lowerLimit': '-1.1', 'upperLimit': '0.1'}, {'value': '0.3', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '0.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216', 'description': 'blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).', 'unitOfMeasure': 'ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV/RTV QD Population (APV30003)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)'}, {'id': 'OG001', 'title': 'FPV/RTV BID Population (APV30003)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003'}, {'id': 'OG002', 'title': 'PI-Naïve Population (Other Studies)', 'description': 'FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study'}, {'id': 'OG003', 'title': 'PI-Experienced Population (Other Studies)', 'description': 'FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study'}], 'classes': [{'title': 'Week 48, n=61, 65 , 45, 7', 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '0.4'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-1.1', 'upperLimit': '0.8'}, {'value': '-0.1', 'groupId': 'OG002', 'lowerLimit': '-0.8', 'upperLimit': '0.8'}, {'value': '-0.8', 'groupId': 'OG003', 'lowerLimit': '-0.8', 'upperLimit': '-0.1'}]}]}, {'title': 'Week 96, n=47, 52, 42, 5', 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '0'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.8', 'upperLimit': '0.8'}, {'value': '-0.1', 'groupId': 'OG002', 'lowerLimit': '-0.7', 'upperLimit': '0.4'}, {'value': '-0.3', 'groupId': 'OG003', 'lowerLimit': '-0.5', 'upperLimit': '0'}]}]}, {'title': 'Week 132, n=40, 44, 41, 4', 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-1.5', 'upperLimit': '-0.1'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-1.6', 'upperLimit': '0.5'}, {'value': '-0.2', 'groupId': 'OG002', 'lowerLimit': '-1.1', 'upperLimit': '1.0'}, {'value': '-1.5', 'groupId': 'OG003', 'lowerLimit': '-2.7', 'upperLimit': '-0.3'}]}]}, {'title': 'Week 168, n=31, 40, 3, 5', 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '0.3'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '0.5'}, {'value': '-0.6', 'groupId': 'OG002', 'lowerLimit': '-1.0', 'upperLimit': '-0.4'}, {'value': '-1.4', 'groupId': 'OG003', 'lowerLimit': '-1.4', 'upperLimit': '0.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1) and Weeks 48, 96, 132, and 168', 'description': 'Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).', 'unitOfMeasure': 'ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies. Only those participants contributing data at the indicated time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Final Analysis Population (APV30005)', 'description': 'FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006'}], 'classes': [{'title': 'Week 120, n=14', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '5.8'}]}]}, {'title': 'Week 180, n=14', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '6.0'}]}]}, {'title': 'Week 204, n=106', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '4.8'}]}]}, {'title': 'Week 216, n=102', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '4.5'}]}]}, {'title': 'Week 432, n=40', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '4.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 120, 180, 204, 216, and 432', 'description': 'Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV Population (APV30001)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)'}, {'id': 'OG001', 'title': 'NFV Population (APV30001)', 'description': 'FPV +/- RTV + background regimen in participants who had received NFV in APV30001'}, {'id': 'OG002', 'title': 'FPV Population (APV30002)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)'}, {'id': 'OG003', 'title': 'NFV Population (APV30002)', 'description': 'FPV +/- RTV + background regimen in participants who had received NFV in APV30002'}], 'classes': [{'title': 'AST; Week 48, n=117, 17, 215, 47', 'categories': [{'measurements': [{'value': '-7', 'groupId': 'OG000', 'lowerLimit': '-14', 'upperLimit': '-1'}, {'value': '-2', 'groupId': 'OG001', 'lowerLimit': '-3', 'upperLimit': '5'}, {'value': '-7', 'groupId': 'OG002', 'lowerLimit': '-17', 'upperLimit': '-1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '-5', 'upperLimit': '5'}]}]}, {'title': 'AST; Week 120, n=96, 15, 182, 40', 'categories': [{'measurements': [{'value': '-8', 'groupId': 'OG000', 'lowerLimit': '-19', 'upperLimit': '-1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-8', 'upperLimit': '4'}, {'value': '-8', 'groupId': 'OG002', 'lowerLimit': '-19', 'upperLimit': '-2'}, {'value': '1', 'groupId': 'OG003', 'lowerLimit': '-3', 'upperLimit': '4'}]}]}, {'title': 'AST; Week 180, n=80, 12, 154, 33', 'categories': [{'measurements': [{'value': '-10', 'groupId': 'OG000', 'lowerLimit': '-19', 'upperLimit': '-3'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '-5', 'upperLimit': '4'}, {'value': '-7', 'groupId': 'OG002', 'lowerLimit': '-18', 'upperLimit': '-1'}, {'value': '-2', 'groupId': 'OG003', 'lowerLimit': '-4', 'upperLimit': '2'}]}]}, {'title': 'AST; Week 204, n=77, 12, 151, 27', 'categories': [{'measurements': [{'value': '-7', 'groupId': 'OG000', 'lowerLimit': '-18', 'upperLimit': '-1'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '-4', 'upperLimit': '6'}, {'value': '-7', 'groupId': 'OG002', 'lowerLimit': '-18', 'upperLimit': '-1'}, {'value': '-2', 'groupId': 'OG003', 'lowerLimit': '-4', 'upperLimit': '2'}]}]}, {'title': 'AST; Week 216, n=79, 0, 142, 4', 'categories': [{'measurements': [{'value': '-9', 'groupId': 'OG000', 'lowerLimit': '-16', 'upperLimit': '-1'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-7', 'groupId': 'OG002', 'lowerLimit': '-17', 'upperLimit': '0'}, {'value': '1', 'groupId': 'OG003', 'lowerLimit': '-7', 'upperLimit': '8'}]}]}, {'title': 'ALT; Week 48, n=117, 17, 216, 47', 'categories': [{'measurements': [{'value': '-5', 'groupId': 'OG000', 'lowerLimit': '-21', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-3', 'upperLimit': '4'}, {'value': '-8', 'groupId': 'OG002', 'lowerLimit': '-19', 'upperLimit': '1'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '-2', 'upperLimit': '8'}]}]}, {'title': 'ALT; Week 120, n=96, 15, 182, 40', 'categories': [{'measurements': [{'value': '-9', 'groupId': 'OG000', 'lowerLimit': '-29', 'upperLimit': '2'}, {'value': '-1', 'groupId': 'OG001', 'lowerLimit': '-6', 'upperLimit': '7'}, {'value': '-8', 'groupId': 'OG002', 'lowerLimit': '-20', 'upperLimit': '0'}, {'value': '4', 'groupId': 'OG003', 'lowerLimit': '-6', 'upperLimit': '8'}]}]}, {'title': 'ALT; Week 180, n=81, 12, 155, 33', 'categories': [{'measurements': [{'value': '-10', 'groupId': 'OG000', 'lowerLimit': '-27', 'upperLimit': '-1'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '-3', 'upperLimit': '5'}, {'value': '-6', 'groupId': 'OG002', 'lowerLimit': '-19', 'upperLimit': '5'}, {'value': '1', 'groupId': 'OG003', 'lowerLimit': '-5', 'upperLimit': '6'}]}]}, {'title': 'ALT; Week 204, n=77, 12, 152, 27', 'categories': [{'measurements': [{'value': '-10', 'groupId': 'OG000', 'lowerLimit': '-26', 'upperLimit': '0'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '9'}, {'value': '-5', 'groupId': 'OG002', 'lowerLimit': '-19', 'upperLimit': '4'}, {'value': '-1', 'groupId': 'OG003', 'lowerLimit': '-7', 'upperLimit': '5'}]}]}, {'title': 'ALT; Week 216, n=79, 0, 142, 4', 'categories': [{'measurements': [{'value': '-10', 'groupId': 'OG000', 'lowerLimit': '-27', 'upperLimit': '2'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '-6', 'groupId': 'OG002', 'lowerLimit': '-18', 'upperLimit': '2'}, {'value': '-3', 'groupId': 'OG003', 'lowerLimit': '-11', 'upperLimit': '9'}]}]}, {'title': 'Serum lipase; Week 48, n=118, 17, 217, 47', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '10'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '-8', 'upperLimit': '5'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '-7', 'upperLimit': '7'}, {'value': '-2', 'groupId': 'OG003', 'lowerLimit': '-6', 'upperLimit': '1'}]}]}, {'title': 'Serum lipase; Week 120, n=95, 15, 184, 40', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '-4', 'upperLimit': '9'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '6'}, {'value': '-1', 'groupId': 'OG002', 'lowerLimit': '-6', 'upperLimit': '6'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '-4', 'upperLimit': '7'}]}]}, {'title': 'Serum lipase; Week 180, n=81, 12, 156, 33', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '9'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-6', 'upperLimit': '4'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '-5', 'upperLimit': '6'}, {'value': '1', 'groupId': 'OG003', 'lowerLimit': '-5', 'upperLimit': '3'}]}]}, {'title': 'Serum lipase;Week 204, n=78, 12, 153, 27', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '-4', 'upperLimit': '10'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-5', 'upperLimit': '3'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '-5', 'upperLimit': '7'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '-4', 'upperLimit': '6'}]}]}, {'title': 'Serum lipase; Week 216, n=80, 0, 143, 4', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '11'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '-6', 'upperLimit': '9'}, {'value': '-3', 'groupId': 'OG003', 'lowerLimit': '-27', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216', 'description': 'Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).', 'unitOfMeasure': 'units per liter (U/L)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV/RTV QD Population (APV30003)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)'}, {'id': 'OG001', 'title': 'FPV/RTV BID Population (APV30003)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003'}, {'id': 'OG002', 'title': 'PI-Naïve Population (Other Studies)', 'description': 'FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study'}, {'id': 'OG003', 'title': 'PI-Experienced Population (Other Studies)', 'description': 'FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study'}], 'classes': [{'title': 'AST; Week 48, n=73, 78, 83, 65', 'categories': [{'measurements': [{'value': '-6', 'groupId': 'OG000', 'lowerLimit': '-14', 'upperLimit': '3'}, {'value': '-5', 'groupId': 'OG001', 'lowerLimit': '-15', 'upperLimit': '-1'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '-3', 'upperLimit': '4'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '-6', 'upperLimit': '6'}]}]}, {'title': 'AST; Week 96, n=57, 63, 73, 49', 'categories': [{'measurements': [{'value': '-6', 'groupId': 'OG000', 'lowerLimit': '-12', 'upperLimit': '6'}, {'value': '-4', 'groupId': 'OG001', 'lowerLimit': '-18', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '-3', 'upperLimit': '3'}, {'value': '-1', 'groupId': 'OG003', 'lowerLimit': '-9', 'upperLimit': '4'}]}]}, {'title': 'AST; Week 132, n=50, 57, 64, 46', 'categories': [{'measurements': [{'value': '-6', 'groupId': 'OG000', 'lowerLimit': '-13', 'upperLimit': '-1'}, {'value': '-4', 'groupId': 'OG001', 'lowerLimit': '-14', 'upperLimit': '2'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '-3', 'upperLimit': '5'}, {'value': '1', 'groupId': 'OG003', 'lowerLimit': '-5', 'upperLimit': '8'}]}]}, {'title': 'AST; Week 168, n=45, 48, 20, 36', 'categories': [{'measurements': [{'value': '-6', 'groupId': 'OG000', 'lowerLimit': '-14', 'upperLimit': '1'}, {'value': '-6', 'groupId': 'OG001', 'lowerLimit': '-17', 'upperLimit': '-1'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '-1', 'upperLimit': '5'}, {'value': '-1', 'groupId': 'OG003', 'lowerLimit': '-10', 'upperLimit': '5'}]}]}, {'title': 'ALT; Week 48, n=70, 78, 83, 65', 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-13', 'upperLimit': '4'}, {'value': '-6', 'groupId': 'OG001', 'lowerLimit': '-21', 'upperLimit': '1'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '-2', 'upperLimit': '8'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '-9', 'upperLimit': '12'}]}]}, {'title': 'ALT; Week 96, n=59, 63, 73, 49', 'categories': [{'measurements': [{'value': '-4', 'groupId': 'OG000', 'lowerLimit': '-13', 'upperLimit': '9'}, {'value': '-3', 'groupId': 'OG001', 'lowerLimit': '-21', 'upperLimit': '3'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '-3', 'upperLimit': '6'}, {'value': '1', 'groupId': 'OG003', 'lowerLimit': '-10', 'upperLimit': '6'}]}]}, {'title': 'ALT; Week 132, n=51, 58, 64, 46', 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-17', 'upperLimit': '8'}, {'value': '-4', 'groupId': 'OG001', 'lowerLimit': '-18', 'upperLimit': '3'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '-2', 'upperLimit': '8'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '-10', 'upperLimit': '8'}]}]}, {'title': 'ALT; Week 168, n=45, 48, 20, 37', 'categories': [{'measurements': [{'value': '-5', 'groupId': 'OG000', 'lowerLimit': '-23', 'upperLimit': '4'}, {'value': '-5', 'groupId': 'OG001', 'lowerLimit': '-22', 'upperLimit': '4'}, {'value': '6', 'groupId': 'OG002', 'lowerLimit': '-1', 'upperLimit': '9'}, {'value': '-3', 'groupId': 'OG003', 'lowerLimit': '-16', 'upperLimit': '6'}]}]}, {'title': 'Serum lipase; Week 48, n=72, 78, 57, 64', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '-5', 'upperLimit': '8'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '-4', 'upperLimit': '9'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '-3', 'upperLimit': '7'}, {'value': '1', 'groupId': 'OG003', 'lowerLimit': '-4', 'upperLimit': '6'}]}]}, {'title': 'Serum lipase; Week 96, n=59, 63, 52, 49', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '-4', 'upperLimit': '10'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '-5', 'upperLimit': '12'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '-3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG003', 'lowerLimit': '-4', 'upperLimit': '11'}]}]}, {'title': 'Serum lipase; Week 132, n=52, 58, 47, 46', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '-4', 'upperLimit': '10'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '13'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '-3', 'upperLimit': '5'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '-4', 'upperLimit': '11'}]}]}, {'title': 'Serum lipase; Week 168, n=45, 48, 7, 37', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-8', 'upperLimit': '6'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '11'}, {'value': '-5', 'groupId': 'OG002', 'lowerLimit': '-14', 'upperLimit': '8'}, {'value': '3', 'groupId': 'OG003', 'lowerLimit': '-6', 'upperLimit': '16'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1) and Weeks 48, 96, 132, and 168', 'description': 'Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).', 'unitOfMeasure': 'units per liter (U/L)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies. Only those participants contributing data at the indicated time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Final Analysis Population (APV30005)', 'description': 'FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006'}], 'classes': [{'title': 'AST; Week 120, n=14', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '22'}]}]}, {'title': 'AST; Week 180, n=14', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '23'}]}]}, {'title': 'AST; Week 204, n=107', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '23'}]}]}, {'title': 'AST; Week 216, n=106', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '25'}]}]}, {'title': 'AST; Week 432, n=41', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '24'}]}]}, {'title': 'ALT; Week 120, n=14', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '27'}]}]}, {'title': 'ALT; Week 180, n=14', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '36'}]}]}, {'title': 'ALT; Week 204, n=107', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '25'}]}]}, {'title': 'ALT; Week 216, n=106', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '25'}]}]}, {'title': 'ALT; Week 432, n=41', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '24'}]}]}, {'title': 'Serum lipase;Week 120, n=14', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '31', 'upperLimit': '53'}]}]}, {'title': 'Serum lipase; Week 180, n=14', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '49'}]}]}, {'title': 'Serum lipase; Week 204, n=107', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000', 'lowerLimit': '27', 'upperLimit': '44'}]}]}, {'title': 'Serum lipase; Week 216, n=106', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '43'}]}]}, {'title': 'Serum lipase; Week 432, n=41', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '47'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 120, 180, 204, 216, and 432', 'description': 'Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase.', 'unitOfMeasure': 'units per liter (U/L)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '221', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV Population (APV30001)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)'}, {'id': 'OG001', 'title': 'NFV Population (APV30001)', 'description': 'FPV +/- RTV + background regimen in participants who had received NFV in APV30001'}, {'id': 'OG002', 'title': 'FPV Population (APV30002)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)'}, {'id': 'OG003', 'title': 'NFV Population (APV30002)', 'description': 'FPV +/- RTV + background regimen in participants who had received NFV in APV30002'}], 'classes': [{'title': 'Baseline <400 copies, n=119, 219, 54; MD=F', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}]}, {'title': 'Week 48 <400 copies, n=119, 219, 54; MD=F', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}]}, {'title': 'Week 120 <400 copies, n=119, 219, 54; MD=F', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}]}, {'title': 'Week 180 <400 copies, n=119, 219, 54; MD=F', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}]}, {'title': 'Week 216 <400 copies, n=119, 219, 0; MD=F', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG003'}]}]}, {'title': 'Baseline <400 copies, n=119, 219, 54; observed', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}]}, {'title': 'Week 48 <400 copies, n=118, 216, 49; observed', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}]}, {'title': 'Week 120 <400 copies, n=96, 181, 40; observed', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}]}, {'title': 'Week 180 <400 copies, n=82, 158, 34; observed', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}]}, {'title': 'Week 216 <400 copies, n=80, 142, 0; observed', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG003'}]}]}, {'title': 'Baseline <50 copies, n=119, 219, 54; MD=F', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}]}, {'title': 'Week 48 <50 copies, n=119, 219, 54; MD=F', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}]}, {'title': 'Week 120 <50 copies, n=119, 219, 54; MD=F', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}]}, {'title': 'Week 180 <50 copies, n=119, 219, 54; MD=F', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}]}, {'title': 'Week 216 <50 copies, n=119, 219, 0; MD=F', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG003'}]}]}, {'title': 'Baseline <50 copies, n=119, 219, 54; observed', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}]}, {'title': 'Week 48 <50 copies, n=118, 216, 49; observed', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}]}, {'title': 'Week 120 <50 copies, n=96, 181, 40; observed', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}]}]}, {'title': 'Week 180 <50 copies, n=82, 158, 34; observed', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}]}, {'title': 'Week 216 <50 copies, n=80, 142, 0; observed', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Weeks 48, 120, 180, and 216', 'description': 'Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. No participants were analyzed in the NPV APV30001 arm due to their small number.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV/RTV QD Population (APV30003)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)'}, {'id': 'OG001', 'title': 'FPV/RTV BID Population (APV30003)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003'}, {'id': 'OG002', 'title': 'PI-Naïve Population (Other Studies)', 'description': 'FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study'}, {'id': 'OG003', 'title': 'PI-Experienced Population (Other Studies)', 'description': 'FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study'}], 'classes': [{'title': 'Baseline <400 copies, n=73, 78, 104, 86; MD=F', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 <400 copies, n=73, 78, 104, 86; MD=F', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}]}, {'title': 'Week 24 <400 copies, n=73, 78, 104, 86; MD=F', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}]}, {'title': 'Week 48 <400 copies, n=73, 78, 104, 86; MD=F', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}]}, {'title': 'Week 60 <400 copies, n=73, 78, 104, 86; MD=F', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}]}, {'title': 'Week 96 <400 copies, n=73, 78, 104, 86; MD=F', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}]}, {'title': 'Week 132 <400 copies, n=73, 78, 104, 86; MD=F', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}]}, {'title': 'Baseline <400 copies, n=73, 78, 92, 82; observed', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 <400 copies, n=69, 78, 92, 79; observed', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}]}, {'title': 'Week 24 <400 copies, n=73, 75, 93, 79; observed', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}]}, {'title': 'Week 48 <400 copies, n=73, 77, 85, 68; observed', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}]}, {'title': 'Week 60 <400 copies, n=71, 76, 81, 58; observed', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}]}, {'title': 'Week 96 <400 copies, n=60, 62, 75, 51; observed', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}]}, {'title': 'Week 132 <400 copies,n=50, 58, 65, 46; observed', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}]}, {'title': 'Baseline <50 copies, n=73, 78, 104, 86; MD=F', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 <50 copies, n=73, 78, 104, 86; MD=F', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}]}, {'title': 'Week 24 <50 copies, n=73, 78, 104, 86; MD=F', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}]}, {'title': 'Week 48 <50 copies, n=73, 78, 104, 86; MD=F', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}]}, {'title': 'Week 60 <50 copies, n=73, 78, 104, 86; MD=F', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}]}, {'title': 'Week 96 <50 copies, n=73, 78, 104, 86; MD=F', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}]}, {'title': 'Week 132 <50 copies, n=73, 78, 104, 86; MD=F', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}]}, {'title': 'Baseline <50 copies, n=73, 78, 92, 82; observed', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 <50 copies, n=69, 78, 92, 79; observed', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}]}, {'title': 'Week 24 <50 copies, n=73, 75, 93, 79; observed', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}]}, {'title': 'Week 48 <50 copies, n=73, 77, 85, 68; observed', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}]}, {'title': 'Week 60 <50 copies, n=71, 76, 81, 58; observed', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}]}, {'title': 'Week 96 <50 copies, n=60, 62, 75, 51; observed', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}]}, {'title': 'Week 132 <50 copies, n=50, 58, 65, 46; observed', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Weeks 12, 24, 48, 60, 96, and 132', 'description': 'Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants receiving FPV or FPV/RTV in Study APV3005 having participated in Study APV30003 or other studies. The PI-naïve and PI-experienced populations (other studies) had received antiretroviral therapy prior to Baseline.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Final Analysis Population (APV30005)', 'description': 'FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006'}], 'classes': [{'title': 'Week 120 <50 copies, n=14; observed', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': 'Week 180 <50 copies, n=14; observed', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}, {'title': 'Week 240 <50 copies, n=101; observed', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}, {'title': 'Week 300 <50 copies, n=82; observed', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': 'Week 360 <50 copies, n=53; observed', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}, {'title': 'Week 420 <50 copies, n=52; observed', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}, {'title': 'Week 432 <50 copies, n=41; observed', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432', 'description': 'Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma,is an efficacy measure for antiretroviral drugs.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed. In the observed analysis, data are presented for the number of participants still enrolled in the study who are classified as responders.'}, {'type': 'SECONDARY', 'title': 'Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV Population (APV30001)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)'}, {'id': 'OG001', 'title': 'NFV Population (APV30001)', 'description': 'FPV +/- RTV + background regimen in participants who had received NFV in APV30001'}, {'id': 'OG002', 'title': 'FPV Population (APV30002)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)'}, {'id': 'OG003', 'title': 'NFV Population (APV30002)', 'description': 'FPV +/- RTV + background regimen in participants who had received NFV in APV30002'}], 'classes': [{'title': 'Baseline, n=119, 18, 219, 52', 'categories': [{'measurements': [{'value': '211', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '1136'}, {'value': '505', 'groupId': 'OG001', 'lowerLimit': '179', 'upperLimit': '1788'}, {'value': '167', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '813'}, {'value': '297', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '755'}]}]}, {'title': 'Week 48, n=117, 17, 211, 49', 'categories': [{'measurements': [{'value': '426', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '1326'}, {'value': '499', 'groupId': 'OG001', 'lowerLimit': '179', 'upperLimit': '1367'}, {'value': '396', 'groupId': 'OG002', 'lowerLimit': '58', 'upperLimit': '1188'}, {'value': '377', 'groupId': 'OG003', 'lowerLimit': '13', 'upperLimit': '884'}]}]}, {'title': 'Week 120, n=95, 15, 177, 40', 'categories': [{'measurements': [{'value': '512', 'groupId': 'OG000', 'lowerLimit': '116', 'upperLimit': '1289'}, {'value': '613', 'groupId': 'OG001', 'lowerLimit': '274', 'upperLimit': '1406'}, {'value': '475', 'groupId': 'OG002', 'lowerLimit': '90', 'upperLimit': '1595'}, {'value': '439', 'groupId': 'OG003', 'lowerLimit': '124', 'upperLimit': '888'}]}]}, {'title': 'Week 168, n=81, 12, 160, 37', 'categories': [{'measurements': [{'value': '594', 'groupId': 'OG000', 'lowerLimit': '147', 'upperLimit': '1534'}, {'value': '608', 'groupId': 'OG001', 'lowerLimit': '287', 'upperLimit': '1069'}, {'value': '506', 'groupId': 'OG002', 'lowerLimit': '67', 'upperLimit': '1299'}, {'value': '422', 'groupId': 'OG003', 'lowerLimit': '83', 'upperLimit': '835'}]}]}, {'title': 'Week 180, n=78, 9, 153, 33', 'categories': [{'measurements': [{'value': '541', 'groupId': 'OG000', 'lowerLimit': '418', 'upperLimit': '765'}, {'value': '447', 'groupId': 'OG001', 'lowerLimit': '180', 'upperLimit': '768'}, {'value': '494', 'groupId': 'OG002', 'lowerLimit': '113', 'upperLimit': '1261'}, {'value': '413', 'groupId': 'OG003', 'lowerLimit': '129', 'upperLimit': '970'}]}]}, {'title': 'Week 204, n=75, 11, 145, 27', 'categories': [{'measurements': [{'value': '535', 'groupId': 'OG000', 'lowerLimit': '377', 'upperLimit': '709'}, {'value': '563', 'groupId': 'OG001', 'lowerLimit': '226', 'upperLimit': '998'}, {'value': '494', 'groupId': 'OG002', 'lowerLimit': '110', 'upperLimit': '1420'}, {'value': '459', 'groupId': 'OG003', 'lowerLimit': '115', 'upperLimit': '911'}]}]}, {'title': 'Week 216, n=77, 0, 138, 4', 'categories': [{'measurements': [{'value': '608', 'groupId': 'OG000', 'lowerLimit': '477', 'upperLimit': '846'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '534', 'groupId': 'OG002', 'lowerLimit': '117', 'upperLimit': '1687'}, {'value': '548', 'groupId': 'OG003', 'lowerLimit': '102', 'upperLimit': '641'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 48, 120, 168, 180, 204, and 216', 'description': 'Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.', 'unitOfMeasure': 'cells per millimeters cubed (cells/mm^3)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.'}, {'type': 'SECONDARY', 'title': 'Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV/RTV QD Population (APV30003)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)'}, {'id': 'OG001', 'title': 'FPV/RTV BID Population (APV30003)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003'}, {'id': 'OG002', 'title': 'PI-Naïve Population (Other Studies)', 'description': 'FFPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study'}, {'id': 'OG003', 'title': 'PI-Experienced Population (Other Studies)', 'description': 'FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study'}], 'classes': [{'title': 'Baseline, n=72, 78, 94, 76', 'categories': [{'measurements': [{'value': '311', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '1171'}, {'value': '304', 'groupId': 'OG001', 'lowerLimit': '41', 'upperLimit': '845'}, {'value': '477', 'groupId': 'OG002', 'lowerLimit': '130', 'upperLimit': '1224'}, {'value': '361', 'groupId': 'OG003', 'lowerLimit': '6', 'upperLimit': '1354'}]}]}, {'title': 'Week 24, n=71, 73, 92, 75', 'categories': [{'measurements': [{'value': '367', 'groupId': 'OG000', 'lowerLimit': '69', 'upperLimit': '1391'}, {'value': '348', 'groupId': 'OG001', 'lowerLimit': '101', 'upperLimit': '1051'}, {'value': '520', 'groupId': 'OG002', 'lowerLimit': '128', 'upperLimit': '1266'}, {'value': '399', 'groupId': 'OG003', 'lowerLimit': '28', 'upperLimit': '1120'}]}]}, {'title': 'Week 48, n=73, 77, 85, 68', 'categories': [{'measurements': [{'value': '374', 'groupId': 'OG000', 'lowerLimit': '66', 'upperLimit': '914'}, {'value': '386', 'groupId': 'OG001', 'lowerLimit': '99', 'upperLimit': '965'}, {'value': '582', 'groupId': 'OG002', 'lowerLimit': '42', 'upperLimit': '1194'}, {'value': '418', 'groupId': 'OG003', 'lowerLimit': '10', 'upperLimit': '1121'}]}]}, {'title': 'Week 96, n=58, 62, 73, 50', 'categories': [{'measurements': [{'value': '409', 'groupId': 'OG000', 'lowerLimit': '179', 'upperLimit': '868'}, {'value': '417', 'groupId': 'OG001', 'lowerLimit': '82', 'upperLimit': '744'}, {'value': '567', 'groupId': 'OG002', 'lowerLimit': '82', 'upperLimit': '1342'}, {'value': '463', 'groupId': 'OG003', 'lowerLimit': '21', 'upperLimit': '929'}]}]}, {'title': 'Week 132, n=50, 56, 64, 47', 'categories': [{'measurements': [{'value': '395', 'groupId': 'OG000', 'lowerLimit': '120', 'upperLimit': '1015'}, {'value': '386', 'groupId': 'OG001', 'lowerLimit': '38', 'upperLimit': '820'}, {'value': '642', 'groupId': 'OG002', 'lowerLimit': '159', 'upperLimit': '1193'}, {'value': '486', 'groupId': 'OG003', 'lowerLimit': '16', 'upperLimit': '1769'}]}]}, {'title': 'Week 168, n=40, 47, 20, 39', 'categories': [{'measurements': [{'value': '513', 'groupId': 'OG000', 'lowerLimit': '133', 'upperLimit': '1069'}, {'value': '409', 'groupId': 'OG001', 'lowerLimit': '59', 'upperLimit': '1097'}, {'value': '619', 'groupId': 'OG002', 'lowerLimit': '260', 'upperLimit': '1312'}, {'value': '460', 'groupId': 'OG003', 'lowerLimit': '51', 'upperLimit': '890'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 132, and 168', 'description': 'Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.', 'unitOfMeasure': 'cells per millimeters cubed (cells/mm^3)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 and other studies. Only those participants contributing data at the indicated time points were analyzed. The PI-naїve and PI-experienced populations (other studies) had received antiretroviral therapy prior to Baseline.'}, {'type': 'SECONDARY', 'title': 'Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '221', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV Population (APV30001)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)'}, {'id': 'OG001', 'title': 'NFV Population (APV30001)', 'description': 'FPV +/- RTV + background regimen in participants who had received NFV in APV30001'}, {'id': 'OG002', 'title': 'FPV Population (APV30002)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)'}, {'id': 'OG003', 'title': 'NFV Population (APV30002)', 'description': 'FPV +/- RTV + background regimen in participants who had received NFV in APV30002'}], 'classes': [{'title': 'Baseline, n=119, 18, 221, 54', 'categories': [{'measurements': [{'value': '4.82', 'groupId': 'OG000', 'lowerLimit': '1.69', 'upperLimit': '7.4'}, {'value': '1.69', 'groupId': 'OG001', 'lowerLimit': '1.69', 'upperLimit': '5.6'}, {'value': '4.82', 'groupId': 'OG002', 'lowerLimit': '2.65', 'upperLimit': '7.29'}, {'value': '1.78', 'groupId': 'OG003', 'lowerLimit': '1.69', 'upperLimit': '5.66'}]}]}, {'title': 'Week 24, n=119, 17, 217, 51', 'categories': [{'measurements': [{'value': '1.69', 'groupId': 'OG000', 'lowerLimit': '1.69', 'upperLimit': '5.8'}, {'value': '1.69', 'groupId': 'OG001', 'lowerLimit': '1.69', 'upperLimit': '5.7'}, {'value': '1.69', 'groupId': 'OG002', 'lowerLimit': '1.69', 'upperLimit': '5.49'}, {'value': '1.69', 'groupId': 'OG003', 'lowerLimit': '1.69', 'upperLimit': '5.34'}]}]}, {'title': 'Week 48, n=118, 17, 218, 49', 'categories': [{'measurements': [{'value': '1.69', 'groupId': 'OG000', 'lowerLimit': '1.69', 'upperLimit': '5.9'}, {'value': '1.69', 'groupId': 'OG001', 'lowerLimit': '1.69', 'upperLimit': '5.4'}, {'value': '1.69', 'groupId': 'OG002', 'lowerLimit': '1.69', 'upperLimit': '5.03'}, {'value': '1.69', 'groupId': 'OG003', 'lowerLimit': '1.69', 'upperLimit': '4.13'}]}]}, {'title': 'Week 72, n=113, 15, 204, 46', 'categories': [{'measurements': [{'value': '1.69', 'groupId': 'OG000', 'lowerLimit': '1.69', 'upperLimit': '4.8'}, {'value': '1.69', 'groupId': 'OG001', 'lowerLimit': '1.69', 'upperLimit': '3.5'}, {'value': '1.69', 'groupId': 'OG002', 'lowerLimit': '1.69', 'upperLimit': '5.83'}, {'value': '1.69', 'groupId': 'OG003', 'lowerLimit': '1.69', 'upperLimit': '5.34'}]}]}, {'title': 'Week 96, n=106, 15, 192, 43', 'categories': [{'measurements': [{'value': '1.69', 'groupId': 'OG000', 'lowerLimit': '1.69', 'upperLimit': '4.7'}, {'value': '1.69', 'groupId': 'OG001', 'lowerLimit': '1.69', 'upperLimit': '3.6'}, {'value': '1.69', 'groupId': 'OG002', 'lowerLimit': '1.69', 'upperLimit': '5.38'}, {'value': '1.69', 'groupId': 'OG003', 'lowerLimit': '1.69', 'upperLimit': '1.69'}]}]}, {'title': 'Week 120, n=96, 15, 183, 40', 'categories': [{'measurements': [{'value': '1.69', 'groupId': 'OG000', 'lowerLimit': '1.69', 'upperLimit': '4.9'}, {'value': '1.69', 'groupId': 'OG001', 'lowerLimit': '1.69', 'upperLimit': '3.1'}, {'value': '1.69', 'groupId': 'OG002', 'lowerLimit': '1.69', 'upperLimit': '5.53'}, {'value': '1.69', 'groupId': 'OG003', 'lowerLimit': '1.69', 'upperLimit': '3.60'}]}]}, {'title': 'Week 144, n=89, 15, 173, 39', 'categories': [{'measurements': [{'value': '1.69', 'groupId': 'OG000', 'lowerLimit': '1.69', 'upperLimit': '4.2'}, {'value': '1.69', 'groupId': 'OG001', 'lowerLimit': '1.69', 'upperLimit': '3.9'}, {'value': '1.69', 'groupId': 'OG002', 'lowerLimit': '1.69', 'upperLimit': '5.38'}, {'value': '1.69', 'groupId': 'OG003', 'lowerLimit': '1.69', 'upperLimit': '3.82'}]}]}, {'title': 'Week 168, n=81, 14, 160, 38', 'categories': [{'measurements': [{'value': '1.69', 'groupId': 'OG000', 'lowerLimit': '1.69', 'upperLimit': '4.8'}, {'value': '1.69', 'groupId': 'OG001', 'lowerLimit': '1.69', 'upperLimit': '4.0'}, {'value': '1.69', 'groupId': 'OG002', 'lowerLimit': '1.69', 'upperLimit': '5.44'}, {'value': '1.69', 'groupId': 'OG003', 'lowerLimit': '1.69', 'upperLimit': '4.27'}]}]}, {'title': 'Week 180, n=82, 12, 159, 34', 'categories': [{'measurements': [{'value': '1.69', 'groupId': 'OG000', 'lowerLimit': '1.69', 'upperLimit': '4.7'}, {'value': '1.69', 'groupId': 'OG001', 'lowerLimit': '1.69', 'upperLimit': '3.3'}, {'value': '1.69', 'groupId': 'OG002', 'lowerLimit': '1.69', 'upperLimit': '4.71'}, {'value': '1.69', 'groupId': 'OG003', 'lowerLimit': '1.69', 'upperLimit': '3.95'}]}]}, {'title': 'Week 204, n=78, 12, 153, 27', 'categories': [{'measurements': [{'value': '1.69', 'groupId': 'OG000', 'lowerLimit': '1.69', 'upperLimit': '3.8'}, {'value': '1.69', 'groupId': 'OG001', 'lowerLimit': '1.69', 'upperLimit': '3.5'}, {'value': '1.69', 'groupId': 'OG002', 'lowerLimit': '1.69', 'upperLimit': '5.26'}, {'value': '1.69', 'groupId': 'OG003', 'lowerLimit': '1.69', 'upperLimit': '2.91'}]}]}, {'title': 'Week 216, n=80, 0, 143, 4', 'categories': [{'measurements': [{'value': '1.69', 'groupId': 'OG000', 'lowerLimit': '1.69', 'upperLimit': '5.4'}, {'value': 'NA', 'comment': 'No participants were analyzed in this arm at this time point.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.69', 'groupId': 'OG002', 'lowerLimit': '1.69', 'upperLimit': '5.59'}, {'value': '1.69', 'groupId': 'OG003', 'lowerLimit': '1.69', 'upperLimit': '1.69'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216', 'description': 'Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.', 'unitOfMeasure': 'log 10 copies per milliliter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants receiving FPV or FPV/RTV in Study APV30005 having previously particpated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.'}, {'type': 'SECONDARY', 'title': 'Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV/RTV QD Population (APV30003)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)'}, {'id': 'OG001', 'title': 'FPV/RTV BID Population (APV30003)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003'}, {'id': 'OG002', 'title': 'PI-Naïve Population (Other Studies)', 'description': 'FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study'}, {'id': 'OG003', 'title': 'PI-Experienced Population (Other Studies)', 'description': 'FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study'}], 'classes': [{'title': 'Baseline, n=73, 78, 92, 82', 'categories': [{'measurements': [{'value': '3.96', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '5.8'}, {'value': '4.06', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '5.9'}, {'value': '1.7', 'groupId': 'OG002', 'lowerLimit': '1.7', 'upperLimit': '4.9'}, {'value': '1.81', 'groupId': 'OG003', 'lowerLimit': '1.7', 'upperLimit': '6.2'}]}]}, {'title': 'Week 12, n=69, 78, 92, 79', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '5.3'}, {'value': '1.81', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '5.8'}, {'value': '1.7', 'groupId': 'OG002', 'lowerLimit': '1.7', 'upperLimit': '6.0'}, {'value': '2.03', 'groupId': 'OG003', 'lowerLimit': '1.7', 'upperLimit': '5.9'}]}]}, {'title': 'Week 24, n=73, 75, 93, 79', 'categories': [{'measurements': [{'value': '1.69', 'groupId': 'OG000', 'lowerLimit': '1.69', 'upperLimit': '4.8'}, {'value': '1.69', 'groupId': 'OG001', 'lowerLimit': '1.69', 'upperLimit': '5.6'}, {'value': '1.7', 'groupId': 'OG002', 'lowerLimit': '1.7', 'upperLimit': '5.5'}, {'value': '1.9', 'groupId': 'OG003', 'lowerLimit': '1.7', 'upperLimit': '5.7'}]}]}, {'title': 'Week 48, n=73, 77, 85, 68', 'categories': [{'measurements': [{'value': '1.71', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '4.5'}, {'value': '1.69', 'groupId': 'OG001', 'lowerLimit': '1.69', 'upperLimit': '5.8'}, {'value': '1.7', 'groupId': 'OG002', 'lowerLimit': '1.7', 'upperLimit': '5.3'}, {'value': '1.7', 'groupId': 'OG003', 'lowerLimit': '1.7', 'upperLimit': '5.1'}]}]}, {'title': 'Week 72, n=65, 73, 80, 53', 'categories': [{'measurements': [{'value': '1.72', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '5.5'}, {'value': '1.69', 'groupId': 'OG001', 'lowerLimit': '1.69', 'upperLimit': '5.4'}, {'value': '1.7', 'groupId': 'OG002', 'lowerLimit': '1.7', 'upperLimit': '4.7'}, {'value': '1.7', 'groupId': 'OG003', 'lowerLimit': '1.7', 'upperLimit': '5.3'}]}]}, {'title': 'Week 96, n=60, 62, 75, 51', 'categories': [{'measurements': [{'value': '1.69', 'groupId': 'OG000', 'lowerLimit': '1.69', 'upperLimit': '4.9'}, {'value': '1.69', 'groupId': 'OG001', 'lowerLimit': '1.69', 'upperLimit': '5.2'}, {'value': '1.7', 'groupId': 'OG002', 'lowerLimit': '1.7', 'upperLimit': '5.4'}, {'value': '1.7', 'groupId': 'OG003', 'lowerLimit': '1.7', 'upperLimit': '5.8'}]}]}, {'title': 'Week 132, n=50, 58, 65, 46', 'categories': [{'measurements': [{'value': '1.69', 'groupId': 'OG000', 'lowerLimit': '1.69', 'upperLimit': '4.8'}, {'value': '1.69', 'groupId': 'OG001', 'lowerLimit': '1.69', 'upperLimit': '5.8'}, {'value': '1.7', 'groupId': 'OG002', 'lowerLimit': '1.7', 'upperLimit': '4.0'}, {'value': '1.7', 'groupId': 'OG003', 'lowerLimit': '1.7', 'upperLimit': '5.3'}]}]}, {'title': 'Week 168, n=44, 48, 20, 39', 'categories': [{'measurements': [{'value': '1.69', 'groupId': 'OG000', 'lowerLimit': '1.69', 'upperLimit': '4.8'}, {'value': '1.69', 'groupId': 'OG001', 'lowerLimit': '1.69', 'upperLimit': '4.9'}, {'value': '1.7', 'groupId': 'OG002', 'lowerLimit': '1.7', 'upperLimit': '2.8'}, {'value': '1.7', 'groupId': 'OG003', 'lowerLimit': '1.7', 'upperLimit': '4.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168', 'description': 'Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.', 'unitOfMeasure': 'log 10 copies per milliliter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies. Only those participants contributing data at the indicated time points were analyzed. The PI naïve and PI-experienced populations (other studies) had received antiretroviral therapy prior to Baseline.'}, {'type': 'SECONDARY', 'title': 'Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Final Analysis Population (APV30005)', 'description': 'FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006'}], 'classes': [{'title': 'Week 180, n=14', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '4.1'}]}]}, {'title': 'Week 240, n=101', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '4.4'}]}]}, {'title': 'Week 300, n=82', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '4.5'}]}]}, {'title': 'Week 360, n=53', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '4.6'}]}]}, {'title': 'Week 420, n=52', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '4.9'}]}]}, {'title': 'Week 432, n=41', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '4.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 180, 240, 300, 360, 420, and 432', 'description': 'Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.', 'unitOfMeasure': 'log 10 copies per milliliters', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '221', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '73', 'groupId': 'OG004'}, {'value': '78', 'groupId': 'OG005'}, {'value': '104', 'groupId': 'OG006'}, {'value': '86', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV Population (APV30001)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)'}, {'id': 'OG001', 'title': 'NFV Population (APV30001)', 'description': 'FPV +/- RTV + background regimen in participants who had received NFV in APV30001'}, {'id': 'OG002', 'title': 'FPV Population (APV30002)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)'}, {'id': 'OG003', 'title': 'NFV Population (APV30002)', 'description': 'FPV +/- RTV + background regimen in participants who had received NFV in APV30002'}, {'id': 'OG004', 'title': 'FPV/RTV QD Population (APV30003)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)'}, {'id': 'OG005', 'title': 'FPV/RTV BID Population (APV30003)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003'}, {'id': 'OG006', 'title': 'PI-Naïve Population (Other Studies)', 'description': 'FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study'}, {'id': 'OG007', 'title': 'PI-Experienced Population (Other Studies)', 'description': 'FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study'}], 'classes': [{'title': 'CDC class A to CDC class C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'CDC class B to CDC class C', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'CDC class C to new CDC class C', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'CDC class A, B, or C to death (on treatment)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) up to 31 January 2006 (up to Week 264)', 'description': 'The number of participants with progression of HIV-1 disease were assessed using the CDC classification of HIV-1: class A, asymptomatic or lymphadenopathy; class B: symptomatic, but not AIDS; class C, AIDS. A participant is considered to have had a disease progression if they report a CDC Class C event for the first time, if they report a new CDC Class C event, or if they experience any fatal adverse event during the study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '221', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV Population (APV30001)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)'}, {'id': 'OG001', 'title': 'NFV Population (APV30001)', 'description': 'FPV +/- RTV + background regimen in participants who had received NFV in APV30001'}, {'id': 'OG002', 'title': 'FPV Population (APV30002)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)'}, {'id': 'OG003', 'title': 'NFV Population (APV30002)', 'description': 'FPV +/- RTV + background regimen in participants who had received NFV in APV30002'}], 'classes': [{'title': 'Candidiasis, oropharyngeal', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Herpes zoster', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea lasting >1 month', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Candidiasis, vulvovaginal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Cervical dysplasia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Fever lasting >1 month', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hairy leukoplakia, oral', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Peripheral neuropathy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Cytomegalovirus retinitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Herpes simplex', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Mycobacterium tuberculosis, any site', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Encepathopathy, HIV-related', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': "Kaposis's sarcoma, cutaneous", 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Lymphoma,immunoblastic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Mycobacterium avium complex/ M kansaii', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Pneumocystis carinii pneumonia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Progressive multifocal leukoencephalopathy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Toxoplasmosis of brain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Non-CDC HIV-associated conditions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) up to 31 January 2006 (up to Week 264)', 'description': 'The number of participants with the indicated HIV-associated conditions were assessed, excluding recurrences.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants receiving FPV or NFV in Studies APV30001 and APV30002.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV/RTV QD Population (APV30003)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)'}, {'id': 'OG001', 'title': 'FPV/RTV BID Population (APV30003)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003'}, {'id': 'OG002', 'title': 'PI-Naïve Population (Other Studies)', 'description': 'FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study'}, {'id': 'OG003', 'title': 'PI-Experienced Population (Other Studies)', 'description': 'FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study'}], 'classes': [{'title': 'Candidiasis, oropharyngeal', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hairy leukoplakia, oral', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Peripheral neuropathy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea lasting >1 month', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Herpes Zoster', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Mycobacterium tuberculosis, any site', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Other, Non-CDC HIV associated condition', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) up to 31 January 2006 (up to Week 264)', 'description': 'The number of participants with the indicated HIV-associated conditions were assessed.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants receiving FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FPV Population (APV30001)', 'description': 'Fosamprenavir (FPV) +/- ritonavir (RTV) + background regimen in participants who had received FPV in APV30001 (NCT00008554)'}, {'id': 'FG001', 'title': 'NFV Population (APV30001)', 'description': 'FPV +/- RTV + background regimen in participants who had received nelfinavir (NFV) in APV30001'}, {'id': 'FG002', 'title': 'FPV Population (APV30002)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)'}, {'id': 'FG003', 'title': 'NFV Population (APV30002)', 'description': 'FPV +/- RTV + background regimen in participants who had received NFV in APV30002'}, {'id': 'FG004', 'title': 'FPV/RTV Once Daily (QD) Population (APV30003)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)'}, {'id': 'FG005', 'title': 'FPV/RTV Twice Daily (BID) Population (APV30003)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003'}, {'id': 'FG006', 'title': 'Protease Inhibitor (PI)-Naïve Population (Other Studies)', 'description': 'FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study'}, {'id': 'FG007', 'title': 'PI-Experienced Population (Other Studies)', 'description': 'FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study'}, {'id': 'FG008', 'title': 'Final Analysis Population (APV30005)', 'description': 'FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006'}], 'periods': [{'title': 'Interim Analysis', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '221'}, {'groupId': 'FG003', 'numSubjects': '54'}, {'groupId': 'FG004', 'numSubjects': '73'}, {'groupId': 'FG005', 'numSubjects': '78'}, {'groupId': 'FG006', 'numSubjects': '104'}, {'groupId': 'FG007', 'numSubjects': '86'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Ongoing', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '30'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '116'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '36'}, {'groupId': 'FG005', 'numSubjects': '41'}, {'groupId': 'FG006', 'numSubjects': '30'}, {'groupId': 'FG007', 'numSubjects': '37'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '105'}, {'groupId': 'FG003', 'numSubjects': '43'}, {'groupId': 'FG004', 'numSubjects': '37'}, {'groupId': 'FG005', 'numSubjects': '37'}, {'groupId': 'FG006', 'numSubjects': '74'}, {'groupId': 'FG007', 'numSubjects': '49'}, {'groupId': 'FG008', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '9'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '14'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '11'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Clinical Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Insufficient Viral Load Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '24'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Insufficient CD4 Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Switched to Commercially Available Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Participant Non-compliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Participant Wanted to Become Pregnant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'To Simplify Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Participant Had Problems with Alcohol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Participant Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Participant Was Incarcerated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Resistance to FPV', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Principle Investigator Discretion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Principle Investigator Terminated Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Non-adherence', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Site Closing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Lack of Personnel at Site', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Missed Schedule Date', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Inclusion in Other Protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Participant Stopped', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Physician and Participant Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Participant Stopped HIV Medications', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Study Ended', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Participant Needed Interferon', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Ongoing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '30'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}, {'title': 'Final Analysis', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'comment': 'Continued in study; commercial supplies of FPV were unavailable locally at end of Interim Analysis.', 'groupId': 'FG008', 'numSubjects': '111'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '90'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '5'}]}, {'type': 'Insufficient Viral Load Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '4'}]}, {'type': 'Tuberculosis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}]}, {'type': 'Participant Moved to Another Country', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}]}, {'type': 'Poor Adherence', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'APV30005 enabled Human Immunodeficiency Virus (HIV)-infected participants who had received a Fosamprenavir (FPV)-containing or other regimen in a number of studies, including APV30001, APV30002, and APV30003, to receive FPV until 31 January 2006 (Interim Analysis) or until commercial supplies of FPV were available locally, whichever was later.', 'preAssignmentDetails': 'Participants are divided into arms depending on the regimen they received in Studies APV30001, APV30002, and APV30003 or whether they were PI-naïve or PI-experienced at the time they enrolled into other studies. For the final analysis, 111 participants are included who continued in APV30005 after 31 January 2006 until study completion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '73', 'groupId': 'BG004'}, {'value': '78', 'groupId': 'BG005'}, {'value': '104', 'groupId': 'BG006'}, {'value': '86', 'groupId': 'BG007'}, {'value': '753', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'FPV Population (APV30001)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)'}, {'id': 'BG001', 'title': 'NFV Population (APV30001)', 'description': 'FPV +/- RTV + background regimen in participants who had received NFV in APV30001'}, {'id': 'BG002', 'title': 'FPV Population (APV30002)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)'}, {'id': 'BG003', 'title': 'NFV Population (APV30002)', 'description': 'FPV +/- RTV + background regimen in participants who had received NFV in APV30002'}, {'id': 'BG004', 'title': 'FPV/RTV QD Population (APV30003)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)'}, {'id': 'BG005', 'title': 'FPV/RTV BID Population (APV30003)', 'description': 'FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003'}, {'id': 'BG006', 'title': 'PI-Naïve Population (Other Studies)', 'description': 'FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study'}, {'id': 'BG007', 'title': 'PI-Experienced Population (Other Studies)', 'description': 'FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '36.3', 'groupId': 'BG000', 'lowerLimit': '17', 'upperLimit': '70'}, {'value': '35.8', 'groupId': 'BG001', 'lowerLimit': '22', 'upperLimit': '54'}, {'value': '37.7', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '69'}, {'value': '36.2', 'groupId': 'BG003', 'lowerLimit': '26', 'upperLimit': '63'}, {'value': '41.9', 'groupId': 'BG004', 'lowerLimit': '27', 'upperLimit': '58'}, {'value': '42.3', 'groupId': 'BG005', 'lowerLimit': '24', 'upperLimit': '71'}, {'value': '39.3', 'groupId': 'BG006', 'lowerLimit': '21', 'upperLimit': '75'}, {'value': '40.2', 'groupId': 'BG007', 'lowerLimit': '19', 'upperLimit': '60'}, {'value': '38.7', 'groupId': 'BG008', 'lowerLimit': '17', 'upperLimit': '75'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '22', 'groupId': 'BG007'}, {'value': '198', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '64', 'groupId': 'BG004'}, {'value': '66', 'groupId': 'BG005'}, {'value': '80', 'groupId': 'BG006'}, {'value': '64', 'groupId': 'BG007'}, {'value': '555', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '59', 'groupId': 'BG004'}, {'value': '56', 'groupId': 'BG005'}, {'value': '44', 'groupId': 'BG006'}, {'value': '77', 'groupId': 'BG007'}, {'value': '394', 'groupId': 'BG008'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '34', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '226', 'groupId': 'BG008'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}]}]}, {'title': 'American Hispanic', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '113', 'groupId': 'BG008'}]}]}, {'title': 'Other: Race Not Specified', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '12', 'groupId': 'BG008'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of Participants with the Indicated CDC Classification of HIV Infection', 'classes': [{'title': 'Asymptomatic or lymphadenopathy', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}, {'value': '76', 'groupId': 'BG006'}, {'value': '29', 'groupId': 'BG007'}, {'value': '395', 'groupId': 'BG008'}]}]}, {'title': 'Symptomatic, not AIDS', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}, {'value': '18', 'groupId': 'BG007'}, {'value': '175', 'groupId': 'BG008'}]}]}, {'title': 'Acquired Immune Deficiency Syndrome (AIDS)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '39', 'groupId': 'BG007'}, {'value': '183', 'groupId': 'BG008'}]}]}], 'paramType': 'NUMBER', 'description': 'The Centers for Disease Control and Prevention (CDC) 1993 classification system for HIV infection was based on three clinical categories (A, B, and C). Category A comprised asymptomatic acute or primary HIV infection or persistent generalized lymphadenopathy (lymphnode disease). Category B comprised symptomatic conditions not included in clinical categories A or C but attributed to a cell-mediated immunity defect or for which the clinical course or management was complicated by HIV infection. Category C comprised AIDS-defining conditions.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 753}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-11'}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-11', 'studyFirstSubmitDate': '2006-02-24', 'resultsFirstSubmitDate': '2011-09-30', 'studyFirstSubmitQcDate': '2006-02-24', 'lastUpdatePostDateStruct': {'date': '2013-04-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-30', 'studyFirstPostDateStruct': {'date': '2006-02-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Any Adverse Event (AE): Interim Analysis', 'timeFrame': 'Baseline (Day 1) up to 31 January 2006 (up to Week 264)', 'description': 'An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section.'}, {'measure': 'Number of Participants With Any Adverse Event (AE): Final Analysis', 'timeFrame': 'Post January 2006; for up to 241 weeks', 'description': 'An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section.'}, {'measure': 'Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216', 'timeFrame': 'Baseline (Day 1) and Weeks 48, 96, 120, 132, 168, 180, 204, and 216', 'description': 'Fasting blood samples of participants were collected for the assessment of triglycerides (Tri.), cholesterol (Chol.), high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG). Change from Baseline at Weeks (W) 48, 96, 120, 132, 168, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).'}, {'measure': 'Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432', 'timeFrame': 'Weeks 120, 180, 204, 216, and 432', 'description': 'Fasting blood samples of participants were collected for the assessment of triglycerides, cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG).'}, {'measure': 'Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216', 'timeFrame': 'Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216', 'description': 'blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).'}, {'measure': 'Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168', 'timeFrame': 'Baseline (Day 1) and Weeks 48, 96, 132, and 168', 'description': 'Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).'}, {'measure': 'Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432', 'timeFrame': 'Weeks 120, 180, 204, 216, and 432', 'description': 'Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL.'}, {'measure': 'Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216', 'timeFrame': 'Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216', 'description': 'Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).'}, {'measure': 'Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168', 'timeFrame': 'Baseline (Day 1) and Weeks 48, 96, 132, and 168', 'description': 'Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).'}, {'measure': 'Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432', 'timeFrame': 'Weeks 120, 180, 204, 216, and 432', 'description': 'Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)', 'timeFrame': 'Baseline and Weeks 48, 120, 180, and 216', 'description': 'Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.'}, {'measure': 'Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)', 'timeFrame': 'Baseline and Weeks 12, 24, 48, 60, 96, and 132', 'description': 'Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point.'}, {'measure': 'Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)', 'timeFrame': 'Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432', 'description': 'Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma,is an efficacy measure for antiretroviral drugs.'}, {'measure': 'Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis', 'timeFrame': 'Baseline and Weeks 48, 120, 168, 180, 204, and 216', 'description': 'Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.'}, {'measure': 'Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis', 'timeFrame': 'Baseline and Weeks 24, 48, 96, 132, and 168', 'description': 'Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.'}, {'measure': 'Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216', 'timeFrame': 'Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216', 'description': 'Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.'}, {'measure': 'Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168', 'timeFrame': 'Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168', 'description': 'Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.'}, {'measure': 'Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432', 'timeFrame': 'Weeks 180, 240, 300, 360, 420, and 432', 'description': 'Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.'}, {'measure': 'Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline', 'timeFrame': 'Baseline (Day 1) up to 31 January 2006 (up to Week 264)', 'description': 'The number of participants with progression of HIV-1 disease were assessed using the CDC classification of HIV-1: class A, asymptomatic or lymphadenopathy; class B: symptomatic, but not AIDS; class C, AIDS. A participant is considered to have had a disease progression if they report a CDC Class C event for the first time, if they report a new CDC Class C event, or if they experience any fatal adverse event during the study.'}, {'measure': 'Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions', 'timeFrame': 'Baseline (Day 1) up to 31 January 2006 (up to Week 264)', 'description': 'The number of participants with the indicated HIV-associated conditions were assessed, excluding recurrences.'}, {'measure': 'Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions', 'timeFrame': 'Baseline (Day 1) up to 31 January 2006 (up to Week 264)', 'description': 'The number of participants with the indicated HIV-associated conditions were assessed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['antiretroviral therapy naive subjects', 'fosamprenavir', 'HIV-1', 'protease inhibitor', 'pro-drug', 'antiretroviral therapy', 'LEXIVA', 'AGENERASE', 'GW433908', 'amprenavir'], 'conditions': ['Infection, Human Immunodeficiency Virus']}, 'descriptionModule': {'briefSummary': 'GW433908 (fosamprenavir; FPV)is a pro-drug of amprenavir (APV) which is more water soluble and can be formulated into a tablet with a reduced pill burden (four 700mg tablets of FPV versus sixteen 150mg capsules daily for APV. This study is designed to provide additional information on long term safety and tolerability of FPV containing regimens for those subjects who received FPV in previous GlaxoSmithKline studies.', 'detailedDescription': 'ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or non-pregnant/non-lactating females \\>/=13 years of age (or \\>/= 18 years of age according to local requirements).\n* Received fosamprenavir through prior participation in APV20001, APV30002, APV30003 or PRO30017 or have participated in APV30001 or other studies as deemed appropriate by the project team.\n\nExclusion Criteria:\n\n* Permanent discontinuation of GW433908 in a previous study due to intolerance.\n* An active CDC Class C Event.\n* Any condition which, in the opinion of the investigator, would preclude a subject from participation.'}, 'identificationModule': {'nctId': 'NCT00296504', 'briefTitle': 'A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'An Open-Label Phase III Study to Assess the Long Term Safety Profile of GW433908 Containing Regimens in HIV-1 Infected Subjects', 'orgStudyIdInfo': {'id': 'APV30005'}}, 'armsInterventionsModule': {'interventions': [{'name': 'fosamprenavir (GW433908)', 'type': 'DRUG'}, {'name': 'ritonavir', 'type': 'DRUG', 'otherNames': ['fosamprenavir (GW433908)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '94115-1931', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80262', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33145', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '77555-1188', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '13083970', 'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'city': 'Santiago', 'state': 'Región Metro de Santiago', 'country': 'Chile', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '13005', 'city': 'Marseille', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75970', 'city': 'Paris', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '16128', 'city': 'Genoa', 'state': 'Liguria', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}, {'zip': '3000-075', 'city': 'Coimbra', 'country': 'Portugal', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'zip': '6080', 'city': 'Badajoz', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': 'NW3 2QG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ViiV Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ViiV Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}