Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-26 @ 6:19 PM
Study NCT ID:
NCT00323492
Status:
COMPLETED
Last Update Posted:
2010-01-20
First Post:
2006-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
TOTEM: Switch From Other Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to Once Daily Truvada
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069480', 'term': 'Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}], 'ancestors': [{'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'camille.aubron-olivier@gilead.com', 'phone': '+33(0)1 42 737130', 'title': 'Camille Aubron-Olivier', 'organization': 'Gilead Sciences'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead Sciences, investigators in this study may communicate, orally present, or publish in scientific journals or other scholarly media only after the following conditions have been met: results of the study in their entirety have been publicly disclosed by or with the consent of Gilead Sciences in an abstract, manuscript, or presentation form; or study has been completed at all study sites for at least 2 years.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Comparison of adverse events between Truvada and maintain baseline regimen groups is inappropriate since numbers at risk (and exposure to study drug) are not balanced, as described in the adverse event treatment group descriptions.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Truvada', 'description': 'Truvada + NNRTI or PI. The number of participants at risk is the number who started the study by switching to Truvada. Participants in this group were to remain on Truvada for 48 weeks (duration of the study). The number at risk was reduced only by study discontinuation (from 47 at baseline to 40 who completed Study Phase 2).', 'otherNumAtRisk': 47, 'otherNumAffected': 15, 'seriousNumAtRisk': 47, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Maintain Baseline Regimen', 'description': 'Maintain baseline regimen. The number of participants at risk is the number who started the study by maintaining their baseline regimen. Per protocol, participants in this group were allowed to switch to Truvada after Week 12 (Delayed TVD group), therefore the number of participants at risk declines over time (from 45 at baseline to 17 who completed Study Phase 2; with most participants switching to Truvada at Week 12).', 'otherNumAtRisk': 45, 'otherNumAffected': 6, 'seriousNumAtRisk': 45, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'All Truvada', 'description': 'Truvada + NNRTI or PI (all participants who received Truvada during the study, i.e., participants in the Truvada and Delayed Truvada groups). The number of participants at risk is the number who started the study by switching to Truvada (Truvada group), plus those who started the study by maintaining their baseline regimen but who switched to Truvada during the study (Delayed Truvada group). The number of participants at risk increases over time (from 47 at baseline to 72 when the last switch to Truvada took place; 25 participants switched to Truvada from the "maintain baseline regimen" group in Study Phase 2).', 'otherNumAtRisk': 72, 'otherNumAffected': 16, 'seriousNumAtRisk': 72, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tubulointerstitial Nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Prostatic adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 12 in Fasting Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada', 'description': 'Truvada + NNRTI or PI.'}, {'id': 'OG001', 'title': 'Maintain Baseline Regimen', 'description': 'Maintain baseline regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '0.0'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-0.8', 'upperLimit': '0.3'}]}]}], 'analyses': [{'pValue': '0.034', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.42', 'ciLowerLimit': '-0.86', 'ciUpperLimit': '-0.03', 'pValueComment': 'No adjustments for multiple comparisons were made.', 'estimateComment': 'Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.', 'groupDescription': 'Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).', 'statisticalMethod': 'Wilcoxon Rank Sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'No adjustments were applied.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Centralized laboratory assessment. Change = Week 12 value minus baseline value.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Last post-baseline observation carried forward (LOCF) method was used for the analysis if the Week 12 value was missing. A missing datum were replaced by the last post-baseline value.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Week 12 in Fasting Low-density Lipoprotein Cholesterol (LDL-CHO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada', 'description': 'Truvada + NNRTI or PI.'}, {'id': 'OG001', 'title': 'Maintain Baseline Regimen', 'description': 'Maintain baseline regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '0.1'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '0.4'}]}]}], 'analyses': [{'pValue': '0.031', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '-0.03', 'pValueComment': 'No adjustments for multiple comparisons were made.', 'estimateComment': 'Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.', 'groupDescription': 'Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).', 'statisticalMethod': 'Wilcoxon Rank Sum text', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'No adjustments were made.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Centralized laboratory assessment. Change = Week 12 value minus baseline value.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. LOCF method was used for the analysis if the Week 12 value was missing. A missing datum were replaced by the last post-baseline value.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Fasting High-density Lipoprotein Cholesterol (HDL-CHO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada', 'description': 'Truvada + NNRTI or PI.'}, {'id': 'OG001', 'title': 'Maintain Baseline Regimen', 'description': 'Maintain baseline regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.1'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '-0.02', 'pValueComment': 'No adjustments for multiple comparisons were made.', 'estimateComment': 'Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.', 'groupDescription': 'Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).', 'statisticalMethod': 'Wilcoxon Rank Sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'No adjustments were made.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Centralized laboratory assessment. Change = Week 12 value minus baseline value.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Missing values were excluded.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Fasting Total Cholesterol (T-CHO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada', 'description': 'Truvada + NNRTI or PI.'}, {'id': 'OG001', 'title': 'Maintain Baseline Regimen', 'description': 'Maintain baseline regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000', 'lowerLimit': '-1.3', 'upperLimit': '-0.1'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '0.5'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.64', 'ciLowerLimit': '-1.01', 'ciUpperLimit': '-0.27', 'pValueComment': 'No adjustments for multiple comparisons were made.', 'estimateComment': 'Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.', 'groupDescription': 'Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).', 'statisticalMethod': 'Wicoxon Rank Sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'no adjustments were made.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Centralized laboratory assessment. Change = Week 12 value minus baseline value.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Missing values were excluded.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Fasting T-CHO/HDL-CHO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada', 'description': 'Truvada + NNRTI or PI.'}, {'id': 'OG001', 'title': 'Maintain Baseline Regimen', 'description': 'Maintain baseline regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '0.2'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-0.8', 'upperLimit': '0.3'}]}]}], 'analyses': [{'pValue': '0.51', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.19', 'pValueComment': 'No adjustments for multiple comparisons were made.', 'estimateComment': 'Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.', 'groupDescription': 'Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).', 'statisticalMethod': 'Wilcoxon Rank Sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'No adjustments were made.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Centralized laboratory assessment. Change = Week 12 value minus baseline value.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Missing values were excluded.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Fasting HDL-CHO/LDL-CHO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada', 'description': 'Truvada + NNRTI or PI.'}, {'id': 'OG001', 'title': 'Maintain Baseline Regimen', 'description': 'Maintain baseline regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.1'}]}]}], 'analyses': [{'pValue': '0.79', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.02', 'pValueComment': 'No adjustments for multiple comparisons were made.', 'estimateComment': 'Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.', 'groupDescription': 'Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).', 'statisticalMethod': 'Wilcoxon Rank Sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'No adjustments were made.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Centralized laboratory assessment. Change = Week 12 value minus baseline value.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Missing values were excluded.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Fasting Ultra-sensitive C-reactive Protein (Us-CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada', 'description': 'Truvada + NNRTI or PI.'}, {'id': 'OG001', 'title': 'Maintain Baseline Regimen', 'description': 'Maintain baseline regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '0.9'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '-3.2', 'upperLimit': '2.5'}]}]}], 'analyses': [{'pValue': '0.86', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'No adjustments for multiple comparisons were made.', 'groupDescription': 'Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).', 'statisticalMethod': 'Wilcoxon Rank Sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'No adjustments were made.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Local laboratory assessment. Change = Week 12 value minus baseline value.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Missing values were excluded. Assessment of us-CRP was added to the study schedule via protocol amendment part way through the study. This resulted in small numbers of subjects having data available for this analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Fasting Plasma Triglycerides > 10 g/L (> 11.29 mmol/L) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada', 'description': 'Truvada + NNRTI or PI.'}, {'id': 'OG001', 'title': 'Maintain Baseline Regimen', 'description': 'Maintain baseline regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Centralized laboratory assessment', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Missing values were excluded.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Cluster Determinant 4 (CD4) Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada', 'description': 'Truvada + NNRTI or PI.'}, {'id': 'OG001', 'title': 'Maintain Baseline Regimen', 'description': 'Maintain baseline regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000', 'lowerLimit': '-36.0', 'upperLimit': '63.5'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '-31.0', 'upperLimit': '92.0'}]}]}], 'analyses': [{'pValue': '0.65', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'No adjustments for multiple comparisons were made.', 'groupDescription': 'Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).', 'statisticalMethod': 'Wilcoxon Rank Sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'No adjustments were made.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Change = Week 12 value minus baseline value.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Missing values were excluded.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 48 in CD4 Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada', 'description': 'Truvada + NNRTI or PI.'}, {'id': 'OG001', 'title': 'Maintain Baseline Regimen', 'description': 'Maintain baseline regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.0', 'groupId': 'OG000', 'lowerLimit': '-37.0', 'upperLimit': '116.0'}, {'value': '40.0', 'groupId': 'OG001', 'lowerLimit': '-41.5', 'upperLimit': '79.5'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'No adjustments were made.', 'groupDescription': 'Null Hypothesis: no indication of shift from 0 in distribution of change from baseline. Alternative Hypothesis: shift from 0 is observed in distribution of change from baseline.', 'statisticalMethod': 'Wilcoxon Signed Rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'No adjustments were made.', 'testedNonInferiority': False}, {'pValue': '0.34', 'groupIds': ['OG001'], 'ciPctValue': '95', 'pValueComment': 'No adjustments were made.', 'groupDescription': 'Null Hypothesis: no indication of shift from 0 in distribution of change from baseline. Alternative Hypothesis: shift from 0 is observed in distribution of change from baseline.', 'statisticalMethod': 'Wilcoxon Signed Rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'No adjustments were made.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Week 48', 'description': 'Change = Week 48 value minus baseline value.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Missing values were excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Virologic Control (Plasma HIV-1 Ribonucleic Acid [RNA] < 400 Copies/mL) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada', 'description': 'Truvada + NNRTI or PI.'}, {'id': 'OG001', 'title': 'Maintain Baseline Regimen', 'description': 'Maintain baseline regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'No adjustments were made.', 'groupDescription': 'Null Hypothesis: treatment is not associated with the observed virologic response. Alternative Hypothesis: treatment is associated with the observed virologic response', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'No adjustments were made.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Missing values were treated as failure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to 400 Copies/mL at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada', 'description': 'Truvada + NNRTI or PI.'}, {'id': 'OG001', 'title': 'Maintain Baseline Regimen', 'description': 'Maintain baseline regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Missing values were excluded. Any subjects with plasma HIV-1 RNA greater than or equal to 400 copies/mL at Week 12 were to have virologic genotyping performed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada', 'description': 'Truvada + NNRTI or PI.'}, {'id': 'OG001', 'title': 'Maintain Baseline Regimen', 'description': 'Maintain baseline regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Missing values were treated as failure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Truvada', 'description': 'Truvada + nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI).'}, {'id': 'FG001', 'title': 'Maintain Baseline Regimen', 'description': 'Maintain baseline regimen.'}, {'id': 'FG002', 'title': 'Delayed Truvada', 'description': 'Truvada + NNRTI or PI (participants from the control group who switched NRTIs to Truvada during Study Phase 2).'}], 'periods': [{'title': 'Study Phase 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'comment': 'Not applicable to Phase 1.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Intent-to-Treat (ITT) Analysis Set', 'achievements': [{'comment': 'One subject was excluded from ITT analysis set due to protocol violation.', 'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Study Phase 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '1/45 subjects completed Phase 1 but did not start Phase 2. Week 48 ITT N=46', 'groupId': 'FG000', 'numSubjects': '44'}, {'comment': '2/45 subjects completed Phase 1 but did not start Phase 2. Week 48 ITT N=20 (no switch to Truvada)', 'groupId': 'FG001', 'numSubjects': '18'}, {'comment': 'N=25 switched to Truvada in Phase 2.', 'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Noncompliance with study schedule', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Truvada', 'description': 'Truvada + NNRTI or PI.'}, {'id': 'BG001', 'title': 'Maintain Baseline Regimen', 'description': 'Maintain baseline regimen.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.0', 'spread': '10.7', 'groupId': 'BG000', 'lowerLimit': '42.0', 'upperLimit': '58.0'}, {'value': '43.0', 'spread': '7.7', 'groupId': 'BG001', 'lowerLimit': '39.0', 'upperLimit': '50.0'}, {'value': '47.0', 'spread': '9.8', 'groupId': 'BG002', 'lowerLimit': '41.0', 'upperLimit': '55.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Participants with plasma HIV-1 RNA < 400 copies/mL', 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'At screening', 'unitOfMeasure': 'participants'}, {'title': 'Cluster determinant 4 (CD4) cell count', 'classes': [{'categories': [{'measurements': [{'value': '467', 'groupId': 'BG000', 'lowerLimit': '314', 'upperLimit': '698'}, {'value': '559', 'groupId': 'BG001', 'lowerLimit': '337', 'upperLimit': '714'}, {'value': '528', 'groupId': 'BG002', 'lowerLimit': '318', 'upperLimit': '709'}]}]}], 'paramType': 'MEDIAN', 'description': 'At screening', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Low density lipoprotein cholesterol (LDL-CHO)', 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'BG000', 'lowerLimit': '3.2', 'upperLimit': '4.7'}, {'value': '4.0', 'groupId': 'BG001', 'lowerLimit': '3.6', 'upperLimit': '4.8'}, {'value': '4.0', 'groupId': 'BG002', 'lowerLimit': '3.4', 'upperLimit': '4.7'}]}]}], 'paramType': 'MEDIAN', 'description': 'Centralized laboratory assessment', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Triglycerides', 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'groupId': 'BG000', 'lowerLimit': '1.9', 'upperLimit': '4.0'}, {'value': '2.7', 'groupId': 'BG001', 'lowerLimit': '1.9', 'upperLimit': '3.6'}, {'value': '2.4', 'groupId': 'BG002', 'lowerLimit': '1.9', 'upperLimit': '3.7'}]}]}], 'paramType': 'MEDIAN', 'description': 'Centralized laboratory assessment', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-13', 'studyFirstSubmitDate': '2006-05-05', 'resultsFirstSubmitDate': '2009-03-20', 'studyFirstSubmitQcDate': '2006-05-05', 'lastUpdatePostDateStruct': {'date': '2010-01-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-11-20', 'studyFirstPostDateStruct': {'date': '2006-05-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 12 in Fasting Triglycerides', 'timeFrame': 'Baseline to Week 12', 'description': 'Centralized laboratory assessment. Change = Week 12 value minus baseline value.'}, {'measure': 'Change From Baseline to Week 12 in Fasting Low-density Lipoprotein Cholesterol (LDL-CHO)', 'timeFrame': 'Baseline to Week 12', 'description': 'Centralized laboratory assessment. Change = Week 12 value minus baseline value.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 12 in Fasting High-density Lipoprotein Cholesterol (HDL-CHO)', 'timeFrame': 'Baseline to Week 12', 'description': 'Centralized laboratory assessment. Change = Week 12 value minus baseline value.'}, {'measure': 'Change From Baseline to Week 12 in Fasting Total Cholesterol (T-CHO)', 'timeFrame': 'Baseline to Week 12', 'description': 'Centralized laboratory assessment. Change = Week 12 value minus baseline value.'}, {'measure': 'Change From Baseline to Week 12 in Fasting T-CHO/HDL-CHO', 'timeFrame': 'Baseline to Week 12', 'description': 'Centralized laboratory assessment. Change = Week 12 value minus baseline value.'}, {'measure': 'Change From Baseline to Week 12 in Fasting HDL-CHO/LDL-CHO', 'timeFrame': 'Baseline to Week 12', 'description': 'Centralized laboratory assessment. Change = Week 12 value minus baseline value.'}, {'measure': 'Change From Baseline to Week 12 in Fasting Ultra-sensitive C-reactive Protein (Us-CRP)', 'timeFrame': 'Baseline to Week 12', 'description': 'Local laboratory assessment. Change = Week 12 value minus baseline value.'}, {'measure': 'Percentage of Participants With Fasting Plasma Triglycerides > 10 g/L (> 11.29 mmol/L) at Week 12', 'timeFrame': '12 weeks', 'description': 'Centralized laboratory assessment'}, {'measure': 'Change From Baseline to Week 12 in Cluster Determinant 4 (CD4) Cell Count', 'timeFrame': 'Baseline to Week 12', 'description': 'Change = Week 12 value minus baseline value.'}, {'measure': 'Change From Baseline to Week 48 in CD4 Cell Count', 'timeFrame': 'Baseline to Week 48', 'description': 'Change = Week 48 value minus baseline value.'}, {'measure': 'Percentage of Participants With Virologic Control (Plasma HIV-1 Ribonucleic Acid [RNA] < 400 Copies/mL) at Week 12', 'timeFrame': '12 weeks'}, {'measure': 'Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to 400 Copies/mL at Week 12', 'timeFrame': '12 weeks'}, {'measure': 'Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48', 'timeFrame': '48 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV 1 Infection'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '20053692', 'type': 'DERIVED', 'citation': 'Valantin MA, Bittar R, de Truchis P, Bollens D, Slama L, Giral P, Bonnefont-Rousselot D, Petour P, Aubron-Olivier C, Costagliola D, Katlama C; TOTEM trial group. Switching the nucleoside reverse transcriptase inhibitor backbone to tenofovir disoproxil fumarate + emtricitabine promptly improves triglycerides and low-density lipoprotein cholesterol in dyslipidaemic patients. J Antimicrob Chemother. 2010 Mar;65(3):556-61. doi: 10.1093/jac/dkp462. Epub 2010 Jan 6.'}]}, 'descriptionModule': {'briefSummary': 'This study looked at lipid changes in human immunodeficiency virus type 1 (HIV-1) infected patients when the nucleoside reverse transcriptase inhibitors (NRTIs) in their existing highly active antiretroviral therapy (HAART) regimen were switched to Truvada® (a fixed dose combination tablet of emtricitabine/tenofovir disoproxil fumarate 200 mg/300 mg \\[FTC/TDF\\]). Subjects continued their nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI) at the same dose.', 'detailedDescription': 'This was a Phase IV, multicenter (in France), open label study. The study was conducted in two phases: a comparative randomized phase, which served the primary objective of the study, and a follow-up phase.\n\nStudy Phase 1, Day -14 to Week 12: patients were randomized on a 1:1 basis to one of two groups:\n\n* A. Truvada (substitution of their current NRTIs by Truvada \\[FTC/TDF\\] with continuation of their current NNRTI or PI at the same dose)\n* B. Maintain Baseline Regimen (continuation of previous HAART regimen, i.e., maintained baseline regimen).\n\nThis phase of the study served the primary objective of the study.\n\nStudy Phase 2, roll-over follow-up, Week 12 to Week 48: Patients in the Truvada group continued with Truvada + an NNRTI or PI. Patients in the control group could switch their NRTIs to Truvada in this phase of the study (Delayed Truvada group).\n\nPatients were assessed for efficacy and safety during both phases of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients displaying abnormal fasted triglycerides (\\> 2 g/L \\[2.26 mmol/L\\] and less than or equal to 10 g/L \\[11.29 mmol/L\\]) and/or fasted low density lipoprotein cholesterol (LDL-CHO; \\> 1.6 g/L \\[4.15 mmol/L\\])\n* Patients on stable HAART with 2 NRTIs + 1 NNRTI or 1 PI for at least 3 months prior to screening, and with plasma viral load \\< 400 copies/mL for at least 6 months prior to screening'}, 'identificationModule': {'nctId': 'NCT00323492', 'acronym': 'TOTEM', 'briefTitle': 'TOTEM: Switch From Other Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to Once Daily Truvada', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'Open-label Randomized Multicenter Trial to Evaluate the Impact on the Lipid Profile of the Substitution of the NRTIs of a HAART Regimen by a Once Daily Fixed Dose Combination Tablet of Emtricitabine and Tenofovir DF Versus Maintained Treatment in HIV Infected Controlled Patients.', 'orgStudyIdInfo': {'id': 'GS-FR-164-0109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Truvada', 'description': 'Truvada once daily with continuation of the current NNRTI or PI at randomization', 'interventionNames': ['Drug: Truvada']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Maintain Baseline Regimen', 'description': 'Maintain baseline regimen', 'interventionNames': ['Drug: Current HAART regimen']}, {'type': 'EXPERIMENTAL', 'label': 'Delayed Truvada', 'description': 'Truvada once daily with NNRTI or PI (participants from the comparator group who switched to Truvada during Study Phase 2)', 'interventionNames': ['Drug: Truvada']}, {'type': 'EXPERIMENTAL', 'label': 'All Truvada', 'description': 'Truvada once daily with NNRTI or PI (all participants who received Truvada during the study, i.e., participants in the Truvada and Delayed Truvada groups)', 'interventionNames': ['Drug: Truvada']}], 'interventions': [{'name': 'Truvada', 'type': 'DRUG', 'description': 'Truvada + NNRTI or PI.', 'armGroupLabels': ['All Truvada', 'Delayed Truvada', 'Truvada']}, {'name': 'Current HAART regimen', 'type': 'DRUG', 'description': 'Maintain baseline regimen', 'armGroupLabels': ['Maintain Baseline Regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Gilead Sciences', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Camille Aubron-Olivier', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Camille Aubron-Olivier', 'oldOrganization': 'Gilead Sciences'}}}}