Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-01-29 @ 5:07 AM
Study NCT ID:
NCT02581202
Status:
COMPLETED
Last Update Posted:
2019-06-06
First Post:
2015-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effectiveness of Dual Therapy (Lopinavir/Ritonavir + LamivudinE) in Treatment-Experienced HIV Infected Patients in the Russian Federation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Russia']}, 'interventionBrowseModule': {'meshes': [{'id': 'D061466', 'term': 'Lopinavir'}, {'id': 'D019259', 'term': 'Lamivudine'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D016047', 'term': 'Zalcitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 48', 'description': 'This study is non-interventional. Therefore, adverse events were not recorded in a solicited manner as in an interventional trial, but were recorded by spontaneous reporting in line with the requirements described in EMA Guideline on GVP module VI and local pharmacovigilance practice of the Russian Federation.', 'eventGroups': [{'id': 'EG000', 'title': 'HIV-1 Infected Participants', 'description': 'Treatment-experienced HIV-1 infected participants with an undetectable plasma HIV-1 RNA level\n\nlopinavir/ritonavir: tablet\n\nLamivudine: tablet', 'otherNumAtRisk': 216, 'deathsNumAtRisk': 216, 'otherNumAffected': 3, 'seriousNumAtRisk': 216, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Drug ineffective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98.18', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000', 'lowerLimit': '97.29', 'upperLimit': '99.99'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Untransformed Data)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'categories': [{'measurements': [{'value': '25.22', 'spread': '3.158', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'categories': [{'measurements': [{'value': '0.22', 'spread': '3.158', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data on HIV-1 RNA viral load at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Base-10 Logarithm Transformed Data)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'categories': [{'measurements': [{'value': '3.22', 'spread': '0.072', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.072', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data on HIV-1 RNA viral load at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Untransformed Data)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'categories': [{'measurements': [{'value': '25.00', 'spread': '0.000', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'description': 'Statistics for absolute HIV-1 RNA viral load, where all participants with undetectable HIV-1-RNA viral load data were included into calculations with half of the lower indication limit (50/2 copies/mL, or 25.00 copies/mL).', 'unitOfMeasure': 'copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data on HIV-1 RNA viral load at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Base-10 Logarithm Transformed Data)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'categories': [{'measurements': [{'value': '3.22', 'spread': '0.000', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.000', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data on HIV-1 RNA viral load at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'categories': [{'measurements': [{'value': '32.50', 'spread': '7.554', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'categories': [{'measurements': [{'value': '0.96', 'spread': '4.879', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'percentage of lymphocytes that are CD4+', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with valid measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'categories': [{'measurements': [{'value': '33.11', 'spread': '7.860', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'categories': [{'measurements': [{'value': '1.43', 'spread': '6.314', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'unitOfMeasure': 'percentage of lymphocytes that are CD4+', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with valid measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'categories': [{'measurements': [{'value': '703.43', 'spread': '223.790', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'categories': [{'measurements': [{'value': '64.70', 'spread': '165.060', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with valid measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'categories': [{'measurements': [{'value': '752.44', 'spread': '234.366', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'categories': [{'measurements': [{'value': '111.75', 'spread': '184.477', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with valid measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Developed Resistance to Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs), and Protease Inhibitors (PIs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'NRTI', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'NNRTI', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'PI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 48', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with HIV-1 RNA viral load detected levels of ≥ 50 copies/mL up to Week 24.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values: arm circumference', 'categories': [{'measurements': [{'value': '29.82', 'spread': '4.617', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL: arm circumference', 'categories': [{'measurements': [{'value': '-0.38', 'spread': '2.953', 'groupId': 'OG000'}]}]}, {'title': 'Absolute values: hip circumference', 'categories': [{'measurements': [{'value': '54.62', 'spread': '8.112', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL: hip circumference', 'categories': [{'measurements': [{'value': '0.57', 'spread': '5.575', 'groupId': 'OG000'}]}]}, {'title': 'Absolute values: waist circumference', 'categories': [{'measurements': [{'value': '83.29', 'spread': '12.282', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL: waist circumference', 'categories': [{'measurements': [{'value': '0.31', 'spread': '5.998', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values: arm circumference', 'categories': [{'measurements': [{'value': '30.05', 'spread': '4.781', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL: arm circumference', 'categories': [{'measurements': [{'value': '-0.20', 'spread': '2.935', 'groupId': 'OG000'}]}]}, {'title': 'Absolute values: hip circumference', 'categories': [{'measurements': [{'value': '55.25', 'spread': '8.395', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL: hip circumference', 'categories': [{'measurements': [{'value': '1.14', 'spread': '6.739', 'groupId': 'OG000'}]}]}, {'title': 'Absolute values: waist circumference', 'categories': [{'measurements': [{'value': '83.64', 'spread': '12.742', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL: waist circumference', 'categories': [{'measurements': [{'value': '0.63', 'spread': '6.026', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'categories': [{'measurements': [{'value': '29.37', 'spread': '28.674', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'categories': [{'measurements': [{'value': '-1.31', 'spread': '21.483', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'categories': [{'measurements': [{'value': '28.35', 'spread': '28.386', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'categories': [{'measurements': [{'value': '-2.14', 'spread': '25.666', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (µmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'categories': [{'measurements': [{'value': '39.81', 'spread': '36.996', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'categories': [{'measurements': [{'value': '19.06', 'spread': '35.093', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (µmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'categories': [{'measurements': [{'value': '27.56', 'spread': '11.950', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'categories': [{'measurements': [{'value': '6.81', 'spread': '10.950', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'categories': [{'measurements': [{'value': '26.90', 'spread': '21.575', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'categories': [{'measurements': [{'value': '-0.38', 'spread': '17.234', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'categories': [{'measurements': [{'value': '26.92', 'spread': '21.050', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'categories': [{'measurements': [{'value': '-0.49', 'spread': '20.640', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (µmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'categories': [{'measurements': [{'value': '46.56', 'spread': '65.596', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'categories': [{'measurements': [{'value': '25.00', 'spread': '65.300', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (µmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'categories': [{'measurements': [{'value': '27.19', 'spread': '14.543', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'categories': [{'measurements': [{'value': '5.63', 'spread': '10.966', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'categories': [{'measurements': [{'value': '4.88', 'spread': '0.690', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.838', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'categories': [{'measurements': [{'value': '4.83', 'spread': '0.755', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.818', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: HDL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.53', 'spread': '0.594', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.622', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: HDL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.43', 'spread': '0.465', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.568', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'categories': [{'measurements': [{'value': '10.00', 'spread': '2.342', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'categories': [{'measurements': [{'value': '0.68', 'spread': '2.683', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'µEq/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'categories': [{'measurements': [{'value': '10.00', 'spread': '2.358', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'categories': [{'measurements': [{'value': '0.69', 'spread': '2.760', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'unitOfMeasure': 'µEq/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: LDL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.66', 'spread': '0.902', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.726', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: LDL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.92', 'spread': '0.874', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.893', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Serum Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.50', 'spread': '19.488', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.36', 'spread': '15.286', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Serum Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82.13', 'spread': '19.096', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.75', 'spread': '15.801', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.11', 'spread': '0.951', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.928', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.12', 'spread': '1.118', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.986', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.72', 'spread': '1.025', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.70', 'spread': '9.106', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'title': 'Absolute values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.61', 'spread': '0.832', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '1.313', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements at given time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to Week 48', 'description': 'Adverse events were not recorded in a solicited manner as in an interventional trial, but were recorded by spontaneous reporting in line with the requirements described in European Medicines Agency (EMA) Guideline on Good Pharmacovigilance Practices (GVP) module VI and local pharmacovigilance practice of the Russian Federation.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Human Immunodeficiency Virus 1 (HIV-1) Infected Participants', 'description': 'HIV-1-infected participants on any triple highly active antiretroviral therapy (HAART) with plasma HIV-1 ribonucleic acid (RNA) level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to lopinavir with ritonavir plus lamivudine (LPV/r+3TC) as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '216'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '202'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'HIV-1 Infected Participants', 'description': 'HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '38.1', 'spread': '8.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '144', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '72', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '216', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Absolute HIV-1 RNA Viral Load (Untransformed Data)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '25.00', 'spread': '0.000', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Statistics for absolute HIV-1 RNA viral load, where all participants with undetectable HIV-1-RNA viral load data were included into calculations with half of the lower indication limit (50/2 copies/mL, or 25.00 copies/mL).', 'unitOfMeasure': 'copies/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HIV-1 RNA Viral Load (Log10-Transformed Data)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3.22', 'spread': '0.000', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CD4+T-Cell Counts (%)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '31.44', 'spread': '8.396', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of lymphocytes that are CD4+', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CD4+T-Cell Counts (cells/mm^3)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '641.37', 'spread': '251.417', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Arm Circumference', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '30.03', 'spread': '5.290', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hip Circumference', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '53.92', 'spread': '7.096', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist Circumference', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '82.79', 'spread': '11.579', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Alanine Aminotransferase (U/L)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '31.48', 'spread': '33.910', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'U/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with an evaluable baseline assessment'}, {'title': 'Alanine Aminotransferase (µmol/L)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '20.75', 'spread': '7.979', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with an evaluable baseline assessment'}, {'title': 'Aspartate Aminotransferase (U/L)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27.69', 'spread': '22.913', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'U/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with an evaluable baseline assessment'}, {'title': 'Aspartate Aminotransferase (µmol/L)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '21.56', 'spread': '11.933', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with an evaluable baseline assessment'}, {'title': 'Glucose', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4.96', 'spread': '0.590', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'High Density Lipoprotein (HDL)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.45', 'spread': '0.479', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with an evaluable baseline assessment'}, {'title': 'Insulin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9.32', 'spread': '2.085', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'µEq/mL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with an evaluable baseline assessment'}, {'title': 'Low Density Lipoprotein (LDL)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.75', 'spread': '0.866', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with an evaluable baseline assessment'}, {'title': 'Serum Creatinine', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '78.61', 'spread': '18.136', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with an evaluable baseline assessment'}, {'title': 'Total Cholesterol', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5.04', 'spread': '0.980', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with an evaluable baseline assessment'}, {'title': 'Triglycerides', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.29', 'spread': '8.107', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with an evaluable assessment at baseline'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-08-17', 'size': 637968, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-05-15T10:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-21'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-22', 'studyFirstSubmitDate': '2015-10-19', 'resultsFirstSubmitDate': '2018-05-23', 'studyFirstSubmitQcDate': '2015-10-19', 'lastUpdatePostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-20', 'studyFirstPostDateStruct': {'date': '2015-10-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 48', 'timeFrame': 'Week 48'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 24', 'timeFrame': 'Week 24'}, {'measure': 'Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Untransformed Data)', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Base-10 Logarithm Transformed Data)', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Untransformed Data)', 'timeFrame': 'Baseline, Week 48', 'description': 'Statistics for absolute HIV-1 RNA viral load, where all participants with undetectable HIV-1-RNA viral load data were included into calculations with half of the lower indication limit (50/2 copies/mL, or 25.00 copies/mL).'}, {'measure': 'Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Base-10 Logarithm Transformed Data)', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 24', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 48', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 24', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 48', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Number of Participants Who Developed Resistance to Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs), and Protease Inhibitors (PIs)', 'timeFrame': 'Week 48'}, {'measure': 'Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (U/L)', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (U/L)', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (µmol/L)', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (µmol/L)', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (U/L)', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (U/L)', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (µmol/L)', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (µmol/L)', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Glucose', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Glucose', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: HDL', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: HDL', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Insulin', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Insulin', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: LDL', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: LDL', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Serum Creatinine', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Serum Creatinine', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Total Cholesterol', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Total Cholesterol', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Triglycerides', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Triglycerides', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'up to Week 48', 'description': 'Adverse events were not recorded in a solicited manner as in an interventional trial, but were recorded by spontaneous reporting in line with the requirements described in European Medicines Agency (EMA) Guideline on Good Pharmacovigilance Practices (GVP) module VI and local pharmacovigilance practice of the Russian Federation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['antiretroviral therapy'], 'conditions': ['HIV-1 Infection']}, 'descriptionModule': {'briefSummary': 'This study seeks to assess the virologic effectiveness of dual therapy (lopinavir/ ritonavir (LPV/r) + lamivudine (3TC)) in treatment-experienced human immunodeficiency virus 1 (HIV-1) infected participants with an undetectable plasma HIV-1 (ribonucleic acid) RNA level (for at least 6 months) at the 48 week time point of treatment in the routine clinical settings of the Russian Federation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'HIV-1 infected participants on any triple HAART with undetectable plasma HIV-1 RNA level for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r + 3TC in the routine clinical settings.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 years and older (male and female).\n2. HIV-1 infected patients on any triple HAART with plasma HIV-1 RNA level \\<50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r + 3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r + 3TC) no more than 60 days ago.\n3. Cumulative HAART experience at least 6 months.\n4. Authorization (Consent) for Use/Disclosure of Data signed by the patient.\n\nExclusion Criteria:\n\n1. Contraindications to lopinavir/ritonavir and lamivudine\n2. Previous participation in this program'}, 'identificationModule': {'nctId': 'NCT02581202', 'acronym': 'SIMPLE', 'briefTitle': 'The Effectiveness of Dual Therapy (Lopinavir/Ritonavir + LamivudinE) in Treatment-Experienced HIV Infected Patients in the Russian Federation', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'ProSpective, MultI-Center, Observational PrograM to Assess the Effectiveness of Dual TheraPy (Lopinavir/Ritonavir + LamivudinE) in Treatment-Experienced HIV Infected Patients in the Routine Clinical Settings of the Russian Federation (SIMPLE)', 'orgStudyIdInfo': {'id': 'P15-452'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV-1 infected participants', 'description': 'HIV-1-infected participants on any triple highly active antiretroviral therapy (HAART) with plasma HIV-1 ribonucleic acid (RNA) level \\< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to lopinavir with ritonavir plus lamivudine (LPV/r+3TC) as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.', 'interventionNames': ['Drug: lopinavir/ritonavir', 'Drug: lamivudine']}], 'interventions': [{'name': 'lopinavir/ritonavir', 'type': 'DRUG', 'description': 'tablet', 'armGroupLabels': ['HIV-1 infected participants']}, {'name': 'lamivudine', 'type': 'DRUG', 'description': 'tablet', 'armGroupLabels': ['HIV-1 infected participants']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Andrey Strugovschikov, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}