Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-02-25 @ 11:48 PM
Study NCT ID:
NCT01769469
Status:
COMPLETED
Last Update Posted:
2019-03-27
First Post:
2013-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Renal, Endocrine, and Bone Changes in Response to FTC/TDF in Uninfected Young Men Who Have Sex With Men (YMSM).
Sponsor:
Organization:
Raw JSON
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The Adolescent Medicine Leadership Group (AMLG) retains custody of and primary rights to the data. Use of data must be approved by the protocol team and AMLG.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Since high and low drug exposure groups were not assigned by the study team, but rather "chosen" by the participants and categorized post hoc for analysis, there may be unidentified variables confounding our findings.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Event data not collected through this study; see reporting description below.', 'description': 'Serious and/or Other \\[Not Including Serious\\] Adverse Events were not monitored/assessed through this sub-study; instead, all monitoring of adverse events in ATN 117 (NCT01769469) subjects occurred through the ATN 110 (NCT01772823) or ATN 113 (NCT01769456) studies in which ATN 117 (NCT01769469) subjects were initially enrolled.', 'eventGroups': [{'id': 'EG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Magnitude of Change (Fold Change) in Parathyroid Hormone (PTH) From Baseline to Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. 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For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).', 'unitOfMeasure': 'fold change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with PTH data at baseline and Week 48'}, {'type': 'SECONDARY', 'title': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Change From Baseline to Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. 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There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000', 'lowerLimit': '0.54', 'upperLimit': '2.47'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change in FGF23 will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).', 'unitOfMeasure': 'fold change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with data for baseline and Week 48'}, {'type': 'SECONDARY', 'title': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Most Extreme Fold Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.18', 'groupId': 'OG000', 'lowerLimit': '0.67', 'upperLimit': '2.47'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36 and 48', 'description': 'Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.', 'unitOfMeasure': 'fold change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with at least two measurements available for comparison'}, {'type': 'SECONDARY', 'title': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Time to Most Extreme Fold Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.00', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '48.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with at least two measurements available for comparison'}, {'type': 'SECONDARY', 'title': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 Dihydroxy Vitamin D (1,25 OHD), Change From Baseline to Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.61', 'groupId': 'OG000', 'lowerLimit': '-135.40', 'upperLimit': '197.62'}]}]}], 'analyses': [{'pValue': '0.2452', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with data for baseline and Week 48'}, {'type': 'SECONDARY', 'title': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Magnitude of Fold Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.95', 'groupId': 'OG000', 'lowerLimit': '0.42', 'upperLimit': '2.87'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change in 1,25 OHD will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).', 'unitOfMeasure': 'fold change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with data for baseline and Week 48'}, {'type': 'SECONDARY', 'title': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Most Extreme Fold Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.33', 'groupId': 'OG000', 'lowerLimit': '0.74', 'upperLimit': '3.06'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36 and 48', 'description': 'Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.', 'unitOfMeasure': 'fold change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with at least two measurements available for comparison'}, {'type': 'SECONDARY', 'title': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Time to Most Extreme Fold Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.00', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '48.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with at least two measurements available for comparison'}, {'type': 'SECONDARY', 'title': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Tubular Reabsorption of Phosphate (TRP), Change From Baseline to Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.57', 'groupId': 'OG000', 'lowerLimit': '-10.80', 'upperLimit': '10.54'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'unitOfMeasure': 'percentage of phosphorus reabsorbed', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with data for baseline and Week 48'}, {'type': 'SECONDARY', 'title': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Magnitude of Fold Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.89', 'upperLimit': '1.13'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change in TRP will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).', 'unitOfMeasure': 'fold change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with data for baseline and Week 48'}, {'type': 'SECONDARY', 'title': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Most Extreme Fold Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.05', 'groupId': 'OG000', 'lowerLimit': '0.97', 'upperLimit': '1.47'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36 and 48', 'description': 'Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.', 'unitOfMeasure': 'fold change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with at least two measurements available for comparison'}, {'type': 'SECONDARY', 'title': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Time to Most Extreme Fold Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.00', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '48.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with at least two measurements available for comparison'}, {'type': 'SECONDARY', 'title': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Glomerular Filtration Rate (GFR), Change From Baseline to Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.06', 'groupId': 'OG000', 'lowerLimit': '-32.03', 'upperLimit': '95.42'}]}]}], 'analyses': [{'pValue': '.0806', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'unitOfMeasure': 'ml/min/1.73m^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with data for baseline and Week 48'}, {'type': 'SECONDARY', 'title': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Magnitude of Fold Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.02', 'groupId': 'OG000', 'lowerLimit': '0.76', 'upperLimit': '1.83'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change in GFR will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).', 'unitOfMeasure': 'fold change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with data for baseline and Week 48'}, {'type': 'SECONDARY', 'title': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Most Extreme Fold Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. 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There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.95', 'groupId': 'OG000', 'lowerLimit': '0.27', 'upperLimit': '11.03'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.', 'unitOfMeasure': 'fold change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with at least two measurements available for comparison'}, {'type': 'SECONDARY', 'title': 'Time to Most Extreme Fold Change: UCa/UCr Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.00', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '48.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with at least two measurements available for comparison'}, {'type': 'SECONDARY', 'title': 'Slope of the Curve of Baseline to Most Extreme Fold Change: UCa/UCr Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.01', 'upperLimit': '0.03'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The slope from baseline to most extreme fold change can be expressed as:\n\nSlope = \\[(Most extreme fold change) \\* (baseline value) - (baseline value)\\] / \\[(Time to most extreme fold change) - (time of the baseline value)\\]', 'unitOfMeasure': '(mg/mg)/ weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with at least two measurements available for comparison'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 48 in Serum Phosphate (SPO4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.67', 'upperLimit': '0.47'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'Serum Phosphate (SPO4) Week 48 difference from baseline', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with data for baseline and Week 48'}, {'type': 'SECONDARY', 'title': 'Magnitude of Most Extreme Fold Change: SPO4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.14', 'groupId': 'OG000', 'lowerLimit': '0.79', 'upperLimit': '1.78'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.', 'unitOfMeasure': 'fold change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with at least two measurements available for comparison'}, {'type': 'SECONDARY', 'title': 'Time to Most Extreme Fold Change: SPO4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.00', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '48.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with at least two measurements available for comparison'}, {'type': 'SECONDARY', 'title': 'Slope of the Curve of Baseline to Most Extreme Fold Change: SPO4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000', 'lowerLimit': '-0.05', 'upperLimit': '0.09'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The slope from baseline to most extreme fold change can be expressed as:\n\nSlope = \\[(Most extreme fold change) \\* (baseline value) - (baseline value)\\] / \\[(Time to most extreme fold change) - (time of the baseline value)\\]', 'unitOfMeasure': '(mmol/L)/ weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with at least two measurements available for comparison'}, {'type': 'SECONDARY', 'title': 'Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '-601.14', 'groupId': 'OG000', 'lowerLimit': '-29433.03', 'upperLimit': '42595.81'}]}]}], 'analyses': [{'pValue': '0.5014', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'URBP/UCr Week 48 difference from baseline', 'unitOfMeasure': 'mcg/g', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with data for baseline and Week 48'}, {'type': 'SECONDARY', 'title': 'Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Beta-2 Microglobulin (UB2MG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '-34.78', 'groupId': 'OG000', 'lowerLimit': '-1252.73', 'upperLimit': '597.59'}]}]}], 'analyses': [{'pValue': '0.2431', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'UB2MG Week 48 difference from baseline', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with data for baseline and Week 48'}, {'type': 'SECONDARY', 'title': 'Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Protein (UProt) / Urine Creatinine (UCr)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.07', 'upperLimit': '0.06'}]}]}], 'analyses': [{'pValue': '0.7209', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'UProt/ UCr Week 48 difference from baseline', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with data for baseline and Week 48'}, {'type': 'SECONDARY', 'title': 'Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Glucose (UGluc)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'groupId': 'OG000', 'lowerLimit': '-0.10', 'upperLimit': '0.11'}]}]}], 'analyses': [{'pValue': '0.5379', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'UGluc Week 48 difference from baseline', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with data for baseline and Week 48'}, {'type': 'SECONDARY', 'title': 'Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Serum Creatinine (SCr)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'groupId': 'OG000', 'lowerLimit': '-0.12', 'upperLimit': '0.27'}]}]}], 'analyses': [{'pValue': '0.7986', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'SCr Week 48 difference from baseline', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with data for baseline and Week 48'}, {'type': 'SECONDARY', 'title': 'Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.81', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '11.94'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change in URBP/UCr will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).', 'unitOfMeasure': 'fold change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with data for baseline and Week 48'}, {'type': 'SECONDARY', 'title': 'Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Beta-2 Microglobulin (UB2MG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.72', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '50.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change in UB2MG will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).', 'unitOfMeasure': 'fold change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with data for baseline and Week 48'}, {'type': 'SECONDARY', 'title': 'Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Protein (UProt)/ Urine Creatinine (UCr)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.01', 'groupId': 'OG000', 'lowerLimit': '0.43', 'upperLimit': '2.17'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change in UProt/UCr will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).', 'unitOfMeasure': 'fold change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with data for baseline and Week 48'}, {'type': 'SECONDARY', 'title': 'Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Glucose (UGluc)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.94', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '4.45'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change in UGluc will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).', 'unitOfMeasure': 'fold change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with data for baseline and Week 48'}, {'type': 'SECONDARY', 'title': 'Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Serum Creatinine (SCr)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.85', 'upperLimit': '1.27'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change in SCr will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).', 'unitOfMeasure': 'fold change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with data for baseline and Week 48'}, {'type': 'SECONDARY', 'title': 'Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.80', 'groupId': 'OG000', 'lowerLimit': '0.44', 'upperLimit': '15.27'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36 and 48', 'description': 'Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.', 'unitOfMeasure': 'fold change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with at least two measurements available for comparison'}, {'type': 'SECONDARY', 'title': 'Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UB2MG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.59', 'groupId': 'OG000', 'lowerLimit': '0.11', 'upperLimit': '239.26'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36 and 48', 'description': 'Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.', 'unitOfMeasure': 'fold change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with at least two measurements available for comparison'}, {'type': 'SECONDARY', 'title': 'Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UProt/UCr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.36', 'groupId': 'OG000', 'lowerLimit': '0.42', 'upperLimit': '4.46'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36 and 48', 'description': 'Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.', 'unitOfMeasure': 'fold change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with at least two measurements available for comparison'}, {'type': 'SECONDARY', 'title': 'Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UGluc', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.56', 'groupId': 'OG000', 'lowerLimit': '0.62', 'upperLimit': '11.34'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36 and 48', 'description': 'Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.', 'unitOfMeasure': 'fold change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with at least two measurements available for comparison'}, {'type': 'SECONDARY', 'title': 'Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in SCr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.09', 'groupId': 'OG000', 'lowerLimit': '0.89', 'upperLimit': '1.34'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36 and 48', 'description': 'Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.', 'unitOfMeasure': 'fold change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with at least two measurements available for comparison'}, {'type': 'SECONDARY', 'title': 'Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.00', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '48.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with at least two measurements available for comparison'}, {'type': 'SECONDARY', 'title': 'Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UB2MG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. 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There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.00', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '48.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with at least two measurements available for comparison'}, {'type': 'SECONDARY', 'title': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Time to Most Extreme Fold Change in C-telopeptide (CTX)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.00', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '48.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with at least two measurements available for comparison'}, {'type': 'SECONDARY', 'title': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Slope of the Curve of Baseline to Most Extreme Fold Change in OC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '-0.46', 'upperLimit': '1.19'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The slope from baseline to most extreme fold change can be expressed as:\n\nSlope = \\[(Most extreme fold change) \\* (baseline value) - (baseline value)\\] / \\[(Time to most extreme fold change) - (time of the baseline value)\\]', 'unitOfMeasure': '(mcg/L)/ weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with at least two measurements available for comparison'}, {'type': 'SECONDARY', 'title': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Slope of the Curve of Baseline to Most Extreme Fold Change in CTX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.98', 'groupId': 'OG000', 'lowerLimit': '-64.74', 'upperLimit': '375.51'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks (wks) 4, 8, 12, 24, 36, and 48', 'description': 'The slope from baseline to most extreme fold change can be expressed as:\n\nSlope = \\[(Most extreme fold change) \\* (baseline value) - (baseline value)\\] / \\[(Time to most extreme fold change) - (time of the baseline value)\\]', 'unitOfMeasure': '(pM)/ weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with at least two measurements available for comparison'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in PTH, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.09', 'groupId': 'OG000', 'lowerLimit': '-16.18', 'upperLimit': '26.87'}, {'value': '3.59', 'groupId': 'OG001', 'lowerLimit': '-13.39', 'upperLimit': '24.54'}]}]}], 'analyses': [{'pValue': '0.4043', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.', 'unitOfMeasure': 'pg*wks/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in PTH, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.46', 'groupId': 'OG000', 'lowerLimit': '-15.21', 'upperLimit': '32.73'}, {'value': '0.47', 'groupId': 'OG001', 'lowerLimit': '-28.89', 'upperLimit': '17.50'}]}]}], 'analyses': [{'pValue': '0.2927', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.', 'unitOfMeasure': 'pg*wks/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in FGF23, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.88', 'groupId': 'OG000', 'lowerLimit': '-27.23', 'upperLimit': '17.18'}, {'value': '0.79', 'groupId': 'OG001', 'lowerLimit': '-62.55', 'upperLimit': '26.42'}]}]}], 'analyses': [{'pValue': '0.1134', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.', 'unitOfMeasure': 'pg*wks/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in FGF23, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.66', 'groupId': 'OG000', 'lowerLimit': '-23.96', 'upperLimit': '29.5'}, {'value': '0.60', 'groupId': 'OG001', 'lowerLimit': '-23.57', 'upperLimit': '24.39'}]}]}], 'analyses': [{'pValue': '0.5782', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.', 'unitOfMeasure': 'pg*wks/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in 1,25 OHD, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.80', 'groupId': 'OG000', 'lowerLimit': '-117.15', 'upperLimit': '91.65'}, {'value': '7.07', 'groupId': 'OG001', 'lowerLimit': '-123.12', 'upperLimit': '228.28'}]}]}], 'analyses': [{'pValue': '0.8658', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.', 'unitOfMeasure': 'pmol*wks/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in 1,25 OHD, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.55', 'groupId': 'OG000', 'lowerLimit': '-135.40', 'upperLimit': '67.17'}, {'value': '-8.60', 'groupId': 'OG001', 'lowerLimit': '-63.87', 'upperLimit': '197.62'}]}]}], 'analyses': [{'pValue': '0.5491', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.', 'unitOfMeasure': 'pmol*wks/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in Osteocalcin (OC), by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.87', 'groupId': 'OG000', 'lowerLimit': '-3.61', 'upperLimit': '4.63'}, {'value': '-1.03', 'groupId': 'OG001', 'lowerLimit': '-4.87', 'upperLimit': '5.02'}]}]}], 'analyses': [{'pValue': '0.0238', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.', 'unitOfMeasure': 'mcg*wks/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in Osteocalcin (OC), by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.12', 'groupId': 'OG000', 'lowerLimit': '-4.12', 'upperLimit': '7.77'}, {'value': '-0.10', 'groupId': 'OG001', 'lowerLimit': '-6.17', 'upperLimit': '3.22'}]}]}], 'analyses': [{'pValue': '0.1172', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.', 'unitOfMeasure': 'mcg*wks/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in CTX, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '105.89', 'groupId': 'OG000', 'lowerLimit': '-527.16', 'upperLimit': '817.21'}, {'value': '-25.90', 'groupId': 'OG001', 'lowerLimit': '-819.51', 'upperLimit': '969.14'}]}]}], 'analyses': [{'pValue': '0.1220', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.', 'unitOfMeasure': 'pM*wks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in CTX, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.64', 'groupId': 'OG000', 'lowerLimit': '-646.29', 'upperLimit': '622.69'}, {'value': '-20.72', 'groupId': 'OG001', 'lowerLimit': '-819.51', 'upperLimit': '576.65'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.', 'unitOfMeasure': 'pM*wks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in SCr, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '-0.09', 'upperLimit': '0.14'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-0.19', 'upperLimit': '0.13'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.', 'unitOfMeasure': 'mg*wks/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in SCr, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000', 'lowerLimit': '-0.12', 'upperLimit': '0.15'}, {'value': '-0.02', 'groupId': 'OG001', 'lowerLimit': '-0.10', 'upperLimit': '0.27'}]}]}], 'analyses': [{'pValue': '0.7785', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.', 'unitOfMeasure': 'mg*wks/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in TRP, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.57', 'groupId': 'OG000', 'lowerLimit': '-13.44', 'upperLimit': '15.72'}, {'value': '1.14', 'groupId': 'OG001', 'lowerLimit': '-8.58', 'upperLimit': '11.38'}]}]}], 'analyses': [{'pValue': '0.4933', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.', 'unitOfMeasure': '% of phosphorus reabsorbed*wks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in TRP, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '-7.37', 'upperLimit': '9.51'}, {'value': '-1.28', 'groupId': 'OG001', 'lowerLimit': '-10.43', 'upperLimit': '5.87'}]}]}], 'analyses': [{'pValue': '0.5491', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.', 'unitOfMeasure': '% of phosphorus reabsorbed*wks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UCa/UCr Ratio, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.06', 'upperLimit': '0.12'}, {'value': '-0.01', 'groupId': 'OG001', 'lowerLimit': '-0.15', 'upperLimit': '0.27'}]}]}], 'analyses': [{'pValue': '0.5161', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.', 'unitOfMeasure': 'ratio*weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UCa/UCr Ratio, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.06', 'upperLimit': '0.30'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-0.17', 'upperLimit': '0.11'}]}]}], 'analyses': [{'pValue': '0.5990', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.', 'unitOfMeasure': 'ratio*weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UB2MG, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.28', 'groupId': 'OG000', 'lowerLimit': '-852.86', 'upperLimit': '980.03'}, {'value': '-23.29', 'groupId': 'OG001', 'lowerLimit': '-3716.53', 'upperLimit': '1987.72'}]}]}], 'analyses': [{'pValue': '0.8579', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.', 'unitOfMeasure': 'ng*wks/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UB2MG, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.21', 'groupId': 'OG000', 'lowerLimit': '-802.31', 'upperLimit': '594.44'}, {'value': '-79.82', 'groupId': 'OG001', 'lowerLimit': '-1152.17', 'upperLimit': '393.80'}]}]}], 'analyses': [{'pValue': '0.0719', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.', 'unitOfMeasure': 'ng*wks/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UGluc, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'groupId': 'OG000', 'lowerLimit': '-0.07', 'upperLimit': '0.10'}, {'value': '0.01', 'groupId': 'OG001', 'lowerLimit': '-0.07', 'upperLimit': '0.18'}]}]}], 'analyses': [{'pValue': '0.3148', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.', 'unitOfMeasure': 'mg*wks/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UGluc, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'groupId': 'OG000', 'lowerLimit': '-0.09', 'upperLimit': '0.06'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '-0.09', 'upperLimit': '0.10'}]}]}], 'analyses': [{'pValue': '0.1390', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.', 'unitOfMeasure': 'mg*wks/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in URBP/UCr Ratio, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2281.71', 'groupId': 'OG000', 'lowerLimit': '-20957.98', 'upperLimit': '23305.58'}, {'value': '808.53', 'groupId': 'OG001', 'lowerLimit': '-21627.73', 'upperLimit': '11630.96'}]}]}], 'analyses': [{'pValue': '0.2726', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.', 'unitOfMeasure': 'mcg*wks/g', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in URBP/UCr Ratio, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '-710.86', 'groupId': 'OG000', 'lowerLimit': '-25872.11', 'upperLimit': '12990.80'}, {'value': '1606.38', 'groupId': 'OG001', 'lowerLimit': '-29433.03', 'upperLimit': '8572.38'}]}]}], 'analyses': [{'pValue': '0.5370', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.', 'unitOfMeasure': 'mcg*wks/g', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Lumbar Spine BMD, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.33', 'groupId': 'OG000', 'lowerLimit': '-4.62', 'upperLimit': '4.63'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-2.83', 'upperLimit': '5.75'}]}]}], 'analyses': [{'pValue': '0.2926', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.', 'unitOfMeasure': '% change*wks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Lumbar Spine BMD, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.32', 'groupId': 'OG000', 'lowerLimit': '-4.47', 'upperLimit': '3.74'}, {'value': '0.88', 'groupId': 'OG001', 'lowerLimit': '-2.44', 'upperLimit': '7.98'}]}]}], 'analyses': [{'pValue': '0.1906', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.', 'unitOfMeasure': '% change*wks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in Lumbar Spine BMD Z-score, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.10', 'groupId': 'OG000', 'lowerLimit': '-0.60', 'upperLimit': '0.30'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-0.50', 'upperLimit': '0.60'}]}]}], 'analyses': [{'pValue': '0.2255', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in Lumbar Spine BMD Z-score, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.20', 'groupId': 'OG000', 'lowerLimit': '-0.50', 'upperLimit': '0.20'}, {'value': '-0.10', 'groupId': 'OG001', 'lowerLimit': '-0.80', 'upperLimit': '0.60'}]}]}], 'analyses': [{'pValue': '0.6285', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Femoral Neck BMD, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.80', 'groupId': 'OG000', 'lowerLimit': '-7.34', 'upperLimit': '2.31'}, {'value': '0.62', 'groupId': 'OG001', 'lowerLimit': '-3.89', 'upperLimit': '8.13'}]}]}], 'analyses': [{'pValue': '0.0148', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.', 'unitOfMeasure': '% change*wks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Femoral Neck BMD, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.89', 'groupId': 'OG000', 'lowerLimit': '-5.09', 'upperLimit': '4.39'}, {'value': '1.14', 'groupId': 'OG001', 'lowerLimit': '-2.54', 'upperLimit': '8.48'}]}]}], 'analyses': [{'pValue': '0.0166', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.', 'unitOfMeasure': '% change*wks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in Femoral Neck BMD Z-score, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.10', 'groupId': 'OG000', 'lowerLimit': '-0.60', 'upperLimit': '0.20'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-0.40', 'upperLimit': '0.40'}]}]}], 'analyses': [{'pValue': '0.0277', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in Femoral Neck BMD Z-score, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.10', 'groupId': 'OG000', 'lowerLimit': '-0.50', 'upperLimit': '0.30'}, {'value': '0.10', 'groupId': 'OG001', 'lowerLimit': '-0.70', 'upperLimit': '0.40'}]}]}], 'analyses': [{'pValue': '0.2610', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Total Body BMC, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.40', 'groupId': 'OG000', 'lowerLimit': '-5.38', 'upperLimit': '2.44'}, {'value': '-0.24', 'groupId': 'OG001', 'lowerLimit': '-3.49', 'upperLimit': '8.79'}]}]}], 'analyses': [{'pValue': '0.4154', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.', 'unitOfMeasure': '% change*wks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Total Body BMC, by Overall Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Exposure Group', 'description': 'Highest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}, {'id': 'OG001', 'title': 'Low Exposure Group', 'description': 'Lowest tertile of drug exposure, as measured by AUC (over the study duration) DBS RBC TFV-DP.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.60', 'groupId': 'OG000', 'lowerLimit': '-7.69', 'upperLimit': '3.08'}, {'value': '-1.24', 'groupId': 'OG001', 'lowerLimit': '-3.79', 'upperLimit': '12.21'}]}]}], 'analyses': [{'pValue': '0.7125', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.', 'unitOfMeasure': '% change*wks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Magnitude of Change in Lumbar Spine BMD at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.94', 'upperLimit': '1.08'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).', 'unitOfMeasure': 'fold change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with data for Baseline and Week 48'}, {'type': 'SECONDARY', 'title': 'Magnitude of Change in Lumbar Spine BMD Z-score at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.04', 'groupId': 'OG000', 'lowerLimit': '-0.33', 'upperLimit': '4.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).\n\nThe Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.', 'unitOfMeasure': 'fold change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with data for Baseline and Week 48'}, {'type': 'SECONDARY', 'title': 'Magnitude of Change in Femoral Neck BMD at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.92', 'upperLimit': '1.08'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).', 'unitOfMeasure': 'fold change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with data for Baseline and Week 48'}, {'type': 'SECONDARY', 'title': 'Magnitude of Change in Femoral Neck BMD Z-score at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '-1.00', 'upperLimit': '2.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).', 'unitOfMeasure': 'fold change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with data for Baseline and Week 48'}, {'type': 'SECONDARY', 'title': 'Magnitude of Change in Total Body BMC at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.92', 'upperLimit': '1.12'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).', 'unitOfMeasure': 'fold change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with data for Baseline and Week 48'}, {'type': 'SECONDARY', 'title': 'Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH1 From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'groupId': 'OG000', 'lowerLimit': '-0.067', 'upperLimit': '0.056'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 72', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1)', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.'}, {'type': 'SECONDARY', 'title': 'Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH2 From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'groupId': 'OG000', 'lowerLimit': '-0.07', 'upperLimit': '0.06'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 96', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.'}, {'type': 'SECONDARY', 'title': 'Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH1 From Week 48 (or Last Visit on Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'groupId': 'OG000', 'lowerLimit': '-0.07', 'upperLimit': '0.03'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Wk 48 (or last available measurement on study), Wk 72', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the last measure on study and the first Extension Phase visit (Last - EPH1)', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.'}, {'type': 'SECONDARY', 'title': 'Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH2 From Week 48 (or Last Visit on Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'groupId': 'OG000', 'lowerLimit': '-0.09', 'upperLimit': '0.05'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Wk 48 (or last available measurement on study), Wk 96', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the last measure on study and the second Extension Phase visit (Last - EPH2)', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.'}, {'type': 'SECONDARY', 'title': 'Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH1 From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '-0.60', 'upperLimit': '1.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 72', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1).\n\nThe Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.'}, {'type': 'SECONDARY', 'title': 'Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH2 From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.20', 'groupId': 'OG000', 'lowerLimit': '-0.60', 'upperLimit': '0.90'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 96', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)\n\nThe Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.'}, {'type': 'SECONDARY', 'title': 'Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH1 From Week 48 (or Last Visit on Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.50', 'upperLimit': '0.30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Wk 48 (or last available measurement on study), Wk 72', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the last measure on study and the first Extension Phase visit (Last - EPH1)\n\nThe Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.'}, {'type': 'SECONDARY', 'title': 'Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH2 From Week 48 (or Last Visit on Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.50', 'upperLimit': '0.40'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Wk 48 (or last available measurement on study), Wk 96', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the last measure on study and the second Extension Phase visit (Last - EPH2)\n\nThe Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.'}, {'type': 'SECONDARY', 'title': 'Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH1 From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000', 'lowerLimit': '-0.06', 'upperLimit': '0.05'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 72', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1)', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.'}, {'type': 'SECONDARY', 'title': 'Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH2 From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.07', 'upperLimit': '0.10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 96', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.'}, {'type': 'SECONDARY', 'title': 'Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH1 From Week 48 (or Last Visit on Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.06', 'upperLimit': '0.09'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Wk 48 (or last available measurement on study), Wk 72', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the last measure on study and the first Extension Phase visit (Last- EPH1)', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.'}, {'type': 'SECONDARY', 'title': 'Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH2 From Week 48 (or Last Visit on Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'groupId': 'OG000', 'lowerLimit': '-0.10', 'upperLimit': '0.08'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'W 48 (or last available measurement on study), Wk 96', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the last measure on study and the second Extension Phase visit (Last- EPH2)', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.'}, {'type': 'SECONDARY', 'title': 'Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH1 From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '-0.30', 'upperLimit': '0.70'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 72', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1)\n\nThe Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.'}, {'type': 'SECONDARY', 'title': 'Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH2 From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '-0.50', 'upperLimit': '0.80'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 96', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)\n\nThe Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.'}, {'type': 'SECONDARY', 'title': 'Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH1 From Week 48 (or Last Visit on Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.40', 'upperLimit': '0.70'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 48 (or last available measurement on study), Week 72', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the last measure on study and the first Extension Phase visit (Last - EPH1)\n\nThe Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.'}, {'type': 'SECONDARY', 'title': 'Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH2 From Week 48 (or Last Visit on Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.05', 'groupId': 'OG000', 'lowerLimit': '-0.60', 'upperLimit': '0.60'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Wk 48 (or last available measurement on study), Wk 96', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the last measure on study and the second Extension Phase visit (Last - EPH2).\n\nThe Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.'}, {'type': 'SECONDARY', 'title': 'Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH1 From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.90', 'groupId': 'OG000', 'lowerLimit': '-105.01', 'upperLimit': '129.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 72', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1)', 'unitOfMeasure': 'g', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.'}, {'type': 'SECONDARY', 'title': 'Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH2 From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.49', 'groupId': 'OG000', 'lowerLimit': '-275.00', 'upperLimit': '93.65'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and wk 96', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)', 'unitOfMeasure': 'g', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.'}, {'type': 'SECONDARY', 'title': 'Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH1 From Week 48 (or Last Visit on Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '-27.80', 'groupId': 'OG000', 'lowerLimit': '-80.09', 'upperLimit': '65.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Wk 48 (or last available measurement on study), Wk 72', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the last measure on study and the first Extension Phase visit (Last- EPH1)', 'unitOfMeasure': 'g', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.'}, {'type': 'SECONDARY', 'title': 'Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH2 From Week 48 (or Last Visit on Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'classes': [{'categories': [{'measurements': [{'value': '-46.83', 'groupId': 'OG000', 'lowerLimit': '-145.00', 'upperLimit': '41.84'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Wk 48 (or last available measurement on study), Wk 96', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the last measure on study and the second Extension Phase visit (Last- EPH2)', 'unitOfMeasure': 'g', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir (TDF)/emtricitabine (FTC) (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}], 'dropWithdraws': [{'type': 'Consent Withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Moved Out Of Area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'Prem D/C from ATN 110/113 For Any Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Subject Confirmed HIV Positive', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'The research was conducted at 11 clinical sites. Accrual was open between November 2012 and December 2013.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 101 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.\n\nFTC/TDF (Truvada®): There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '19.62', 'spread': '1.80', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian/Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Black/African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}, {'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}, {'title': 'White/Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Other/Mixed Race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black/African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}]}]}, {'title': 'Non-Black/African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}, {'title': 'Non-Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Parathyroid hormone (PTH)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27.07', 'groupId': 'BG000', 'lowerLimit': '10.44', 'upperLimit': '84.26'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Subjects with available data'}, {'title': 'Fibroblast growth factor 23 (FGF23)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '38.78', 'groupId': 'BG000', 'lowerLimit': '16.92', 'upperLimit': '123.81'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Subjects with available data'}, {'title': '1,25-dihydroxy vitamin D (1,25-OHD RIA)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '160.71', 'groupId': 'BG000', 'lowerLimit': '61.88', 'upperLimit': '343.63'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Subjects with available data'}, {'title': 'Tubular reabsorption of phosphate (TRP)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '91.40', 'groupId': 'BG000', 'lowerLimit': '66.32', 'upperLimit': '99.91'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': '% (of filtered phosphorus reabsorbed)', 'dispersionType': 'FULL_RANGE'}, {'title': 'Actual Free 123(OH)D', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '994.88', 'groupId': 'BG000', 'lowerLimit': '250.21', 'upperLimit': '4176.15'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'fmol/L', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Subjects with available data'}, {'title': 'Estimated glomerular filtration rate (eGFR)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '127.50', 'groupId': 'BG000', 'lowerLimit': '70.74', 'upperLimit': '280.61'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mL/min/1.73^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Serum Creatinine (SCr)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.86', 'groupId': 'BG000', 'lowerLimit': '0.61', 'upperLimit': '1.29'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'FULL_RANGE'}, {'title': 'Serum Calcium (SCa)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9.80', 'groupId': 'BG000', 'lowerLimit': '8.62', 'upperLimit': '10.98'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'FULL_RANGE'}, {'title': 'Urinary Calcium/ Urinary Creatinine ratio (UCa/UCr)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'BG000', 'lowerLimit': '0.00', 'upperLimit': '0.23'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ratio', 'dispersionType': 'FULL_RANGE'}, {'title': 'Serum Phosphate (SPO4)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.16', 'groupId': 'BG000', 'lowerLimit': '0.83', 'upperLimit': '1.74'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'FULL_RANGE'}, {'title': 'Urine Glucose (UGluc)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'BG000', 'lowerLimit': '0.01', 'upperLimit': '0.19'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'FULL_RANGE'}, {'title': 'Urine retinol binding protein to urine creatinine ratio (URBP/UCr)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7092.50', 'groupId': 'BG000', 'lowerLimit': '672.40', 'upperLimit': '98673.09'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mcg/g', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Subjects with data available.'}, {'title': 'Urine beta-2 microglobulin (UB2MG)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '170.04', 'groupId': 'BG000', 'lowerLimit': '9.78', 'upperLimit': '3767.40'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Subjects with available data'}, {'title': 'Urine protein to urine creatinine ratio (UProt/UCr)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'BG000', 'lowerLimit': '0.03', 'upperLimit': '0.20'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ratio', 'dispersionType': 'FULL_RANGE'}, {'title': 'Osteocalcin (OC)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9.50', 'groupId': 'BG000', 'lowerLimit': '1.03', 'upperLimit': '17.31'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mcg/L', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Subjects with available data'}, {'title': 'C-telopeptide (CTX)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '935.76', 'groupId': 'BG000', 'lowerLimit': '278.54', 'upperLimit': '2038.42'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Subjects with available data'}, {'title': 'Lumbar spine bone mineral density (BMD)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.09', 'groupId': 'BG000', 'lowerLimit': '0.76', 'upperLimit': '1.49'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Femoral neck bone mineral density (BMD)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.03', 'groupId': 'BG000', 'lowerLimit': '0.65', 'upperLimit': '1.43'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Subjects with available data'}, {'title': 'Total body bone mineral content (BMC)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2690.83', 'groupId': 'BG000', 'lowerLimit': '1905.32', 'upperLimit': '3702.70'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'g', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood and urine samples to measure: Calcium-Phosphate Balance, Bone Turnover, Renal Glomerular Function, Renal Tubular Function.\n\nDried blood spots (DBS) for FTC and Tenofovir (TFV)concentrations; red blood cell (RBC) for TFV-diphosphate (DP); plasma for FTC, TFV; peripheral blood mononuclear cells (PBMC) for TFV-DP and FTC-triphosphate (TP) collected as part of ATN 110 and ATN 113 will be used in the ATN 117 analysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-25', 'studyFirstSubmitDate': '2013-01-14', 'resultsFirstSubmitDate': '2016-11-21', 'studyFirstSubmitQcDate': '2013-01-14', 'lastUpdatePostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-19', 'studyFirstPostDateStruct': {'date': '2013-01-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Magnitude of Change (Fold Change) in Parathyroid Hormone (PTH) From Baseline to Week 48', 'timeFrame': 'Baseline and Week (wk) 48', 'description': 'The magnitude of change in PTH will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).'}], 'secondaryOutcomes': [{'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Change From Baseline to Week 48', 'timeFrame': 'Baseline and wk 48'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Magnitude of Fold Change', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change in FGF23 will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Most Extreme Fold Change', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36 and 48', 'description': 'Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Time to Most Extreme Fold Change', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 Dihydroxy Vitamin D (1,25 OHD), Change From Baseline to Week 48', 'timeFrame': 'Baseline and wk 48'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Magnitude of Fold Change', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change in 1,25 OHD will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Most Extreme Fold Change', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36 and 48', 'description': 'Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Time to Most Extreme Fold Change', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Tubular Reabsorption of Phosphate (TRP), Change From Baseline to Week 48', 'timeFrame': 'Baseline and wk 48'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Magnitude of Fold Change', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change in TRP will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Most Extreme Fold Change', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36 and 48', 'description': 'Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Time to Most Extreme Fold Change', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Glomerular Filtration Rate (GFR), Change From Baseline to Week 48', 'timeFrame': 'Baseline and wk 48'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Magnitude of Fold Change', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change in GFR will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Most Extreme Fold Change', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36 and 48', 'description': 'Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Time to Most Extreme Fold Change', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Most Extreme Fold Change', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36 and 48', 'description': 'Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Time to Most Extreme Fold Change', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Serum Creatinine (SCr), Time to Most Extreme Fold Change', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Slope of the Curve of Baseline to Most Extreme Fold Change', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The slope from baseline to most extreme fold change can be expressed as:\n\nSlope = \\[(Most extreme fold change) \\* (baseline value) - (baseline value)\\] / \\[(Time to most extreme fold change) - (time of the baseline value)\\]'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: FGF23, Slope of the Curve of Baseline to Most Extreme Fold Change', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The slope from baseline to most extreme fold change can be expressed as:\n\nSlope = \\[(Most extreme fold change) \\* (baseline value) - (baseline value)\\] / \\[(Time to most extreme fold change) - (time of the baseline value)\\]'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25-OHD, Slope of the Curve of Baseline to Most Extreme Fold Change', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The slope from baseline to most extreme fold change can be expressed as:\n\nSlope = \\[(Most extreme fold change) \\* (baseline value) - (baseline value)\\] / \\[(Time to most extreme fold change) - (time of the baseline value)\\]'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Slope of the Curve of Baseline to Most Extreme Fold Change', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The slope from baseline to most extreme fold change can be expressed as:\n\nSlope = \\[(Most extreme fold change) \\* (baseline value) - (baseline value)\\] / \\[(Time to most extreme fold change) - (time of the baseline value)\\]'}, {'measure': 'Change From Baseline to Week 48 in Serum Calcium (SCa)', 'timeFrame': 'Baseline and wk 48', 'description': 'Serum calcium Week 48 difference from baseline'}, {'measure': 'Magnitude of Most Extreme Fold Change: Serum Calcium (SCa)', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.'}, {'measure': 'Time to Most Extreme Fold Change: Serum Calcium (SCa)', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.'}, {'measure': 'Slope of the Curve of Baseline to Most Extreme Fold Change: Serum Calcium (SCa)', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The slope from baseline to most extreme fold change can be expressed as:\n\nSlope = \\[(Most extreme fold change) \\* (baseline value) - (baseline value)\\] / \\[(Time to most extreme fold change) - (time of the baseline value)\\]'}, {'measure': 'Change From Baseline to Week 48 in Urine Calcium (UCa) / Urine Creatinine (UCr)', 'timeFrame': 'Baseline and wk 48', 'description': 'Urine Calcium (UCa) / Urine Creatinine (UCr) ratio Week 48 difference from baseline'}, {'measure': 'Magnitude of Most Extreme Fold Change: UCa/UCr Ratio', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.'}, {'measure': 'Time to Most Extreme Fold Change: UCa/UCr Ratio', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.'}, {'measure': 'Slope of the Curve of Baseline to Most Extreme Fold Change: UCa/UCr Ratio', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The slope from baseline to most extreme fold change can be expressed as:\n\nSlope = \\[(Most extreme fold change) \\* (baseline value) - (baseline value)\\] / \\[(Time to most extreme fold change) - (time of the baseline value)\\]'}, {'measure': 'Change From Baseline to Week 48 in Serum Phosphate (SPO4)', 'timeFrame': 'Baseline and wk 48', 'description': 'Serum Phosphate (SPO4) Week 48 difference from baseline'}, {'measure': 'Magnitude of Most Extreme Fold Change: SPO4', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.'}, {'measure': 'Time to Most Extreme Fold Change: SPO4', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.'}, {'measure': 'Slope of the Curve of Baseline to Most Extreme Fold Change: SPO4', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The slope from baseline to most extreme fold change can be expressed as:\n\nSlope = \\[(Most extreme fold change) \\* (baseline value) - (baseline value)\\] / \\[(Time to most extreme fold change) - (time of the baseline value)\\]'}, {'measure': 'Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)', 'timeFrame': 'Baseline and wk 48', 'description': 'URBP/UCr Week 48 difference from baseline'}, {'measure': 'Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Beta-2 Microglobulin (UB2MG)', 'timeFrame': 'Baseline and wk 48', 'description': 'UB2MG Week 48 difference from baseline'}, {'measure': 'Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Protein (UProt) / Urine Creatinine (UCr)', 'timeFrame': 'Baseline and wk 48', 'description': 'UProt/ UCr Week 48 difference from baseline'}, {'measure': 'Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Glucose (UGluc)', 'timeFrame': 'Baseline and wk 48', 'description': 'UGluc Week 48 difference from baseline'}, {'measure': 'Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Serum Creatinine (SCr)', 'timeFrame': 'Baseline and wk 48', 'description': 'SCr Week 48 difference from baseline'}, {'measure': 'Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change in URBP/UCr will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).'}, {'measure': 'Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Beta-2 Microglobulin (UB2MG)', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change in UB2MG will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).'}, {'measure': 'Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Protein (UProt)/ Urine Creatinine (UCr)', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change in UProt/UCr will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).'}, {'measure': 'Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Glucose (UGluc)', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change in UGluc will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).'}, {'measure': 'Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Serum Creatinine (SCr)', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change in SCr will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).'}, {'measure': 'Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36 and 48', 'description': 'Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.'}, {'measure': 'Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UB2MG', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36 and 48', 'description': 'Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.'}, {'measure': 'Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UProt/UCr', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36 and 48', 'description': 'Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.'}, {'measure': 'Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UGluc', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36 and 48', 'description': 'Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.'}, {'measure': 'Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in SCr', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36 and 48', 'description': 'Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.'}, {'measure': 'Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.'}, {'measure': 'Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UB2MG', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.'}, {'measure': 'Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UProt/UCr', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.'}, {'measure': 'Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UGluc', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.'}, {'measure': 'Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The slope from baseline to most extreme fold change can be expressed as:\n\nSlope = \\[(Most extreme fold change) \\* (baseline value) - (baseline value)\\] / \\[(Time to most extreme fold change) - (time of the baseline value)\\]'}, {'measure': 'Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UB2MG', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The slope from baseline to most extreme fold change can be expressed as:\n\nSlope = \\[(Most extreme fold change) \\* (baseline value) - (baseline value)\\] / \\[(Time to most extreme fold change) - (time of the baseline value)\\]'}, {'measure': 'Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UProt/UCr', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The slope from baseline to most extreme fold change can be expressed as:\n\nSlope = \\[(Most extreme fold change) \\* (baseline value) - (baseline value)\\] / \\[(Time to most extreme fold change) - (time of the baseline value)\\]'}, {'measure': 'Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UGluc', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The slope from baseline to most extreme fold change can be expressed as:\n\nSlope = \\[(Most extreme fold change) \\* (baseline value) - (baseline value)\\] / \\[(Time to most extreme fold change) - (time of the baseline value)\\]'}, {'measure': 'Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in Scr', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The slope from baseline to most extreme fold change can be expressed as:\n\nSlope = \\[(Most extreme fold change) \\* (baseline value) - (baseline value)\\] / \\[(Time to most extreme fold change) - (time of the baseline value)\\]'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Change From Baseline to Week 48 in Osteocalcin (OC)', 'timeFrame': 'Baseline and wk 48', 'description': 'OC Week 48 difference from baseline'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Change From Baseline to Week 48 in C-Telopeptide (CTX)', 'timeFrame': 'Baseline and wk 48', 'description': 'CTX Week 48 difference from baseline'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Most Extreme Fold Change in Osteocalcin (OC)', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36 and 48', 'description': 'Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Most Extreme Fold Change in C-telopeptide (CTX)', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36 and 48', 'description': 'Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: OC, Time to Most Extreme Fold Change', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Time to Most Extreme Fold Change in C-telopeptide (CTX)', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Slope of the Curve of Baseline to Most Extreme Fold Change in OC', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 24, 36, and 48', 'description': 'The slope from baseline to most extreme fold change can be expressed as:\n\nSlope = \\[(Most extreme fold change) \\* (baseline value) - (baseline value)\\] / \\[(Time to most extreme fold change) - (time of the baseline value)\\]'}, {'measure': 'Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Slope of the Curve of Baseline to Most Extreme Fold Change in CTX', 'timeFrame': 'Baseline, Weeks (wks) 4, 8, 12, 24, 36, and 48', 'description': 'The slope from baseline to most extreme fold change can be expressed as:\n\nSlope = \\[(Most extreme fold change) \\* (baseline value) - (baseline value)\\] / \\[(Time to most extreme fold change) - (time of the baseline value)\\]'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in PTH, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in PTH, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in FGF23, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in FGF23, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in 1,25 OHD, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in 1,25 OHD, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in Osteocalcin (OC), by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in Osteocalcin (OC), by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in CTX, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in CTX, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in SCr, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in SCr, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in TRP, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in TRP, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UCa/UCr Ratio, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UCa/UCr Ratio, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UB2MG, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UB2MG, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UGluc, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UGluc, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in URBP/UCr Ratio, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in URBP/UCr Ratio, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Lumbar Spine BMD, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Lumbar Spine BMD, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in Lumbar Spine BMD Z-score, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in Lumbar Spine BMD Z-score, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Femoral Neck BMD, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Femoral Neck BMD, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in Femoral Neck BMD Z-score, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in Femoral Neck BMD Z-score, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Total Body BMC, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 24', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, and 24.'}, {'measure': 'Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Total Body BMC, by Overall Drug Exposure', 'timeFrame': 'Baseline and wk 48', 'description': 'Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.\n\nThe time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48.'}, {'measure': 'Magnitude of Change in Lumbar Spine BMD at Week 48', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).'}, {'measure': 'Magnitude of Change in Lumbar Spine BMD Z-score at Week 48', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).\n\nThe Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.'}, {'measure': 'Magnitude of Change in Femoral Neck BMD at Week 48', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).'}, {'measure': 'Magnitude of Change in Femoral Neck BMD Z-score at Week 48', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).'}, {'measure': 'Magnitude of Change in Total Body BMC at Week 48', 'timeFrame': 'Baseline and wk 48', 'description': 'The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).'}, {'measure': 'Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH1 From Baseline', 'timeFrame': 'Baseline and wk 72', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1)'}, {'measure': 'Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH2 From Baseline', 'timeFrame': 'Baseline and wk 96', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)'}, {'measure': 'Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH1 From Week 48 (or Last Visit on Study)', 'timeFrame': 'Wk 48 (or last available measurement on study), Wk 72', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the last measure on study and the first Extension Phase visit (Last - EPH1)'}, {'measure': 'Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH2 From Week 48 (or Last Visit on Study)', 'timeFrame': 'Wk 48 (or last available measurement on study), Wk 96', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the last measure on study and the second Extension Phase visit (Last - EPH2)'}, {'measure': 'Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH1 From Baseline', 'timeFrame': 'Baseline and wk 72', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1).\n\nThe Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.'}, {'measure': 'Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH2 From Baseline', 'timeFrame': 'Baseline and wk 96', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)\n\nThe Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.'}, {'measure': 'Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH1 From Week 48 (or Last Visit on Study)', 'timeFrame': 'Wk 48 (or last available measurement on study), Wk 72', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the last measure on study and the first Extension Phase visit (Last - EPH1)\n\nThe Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.'}, {'measure': 'Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH2 From Week 48 (or Last Visit on Study)', 'timeFrame': 'Wk 48 (or last available measurement on study), Wk 96', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the last measure on study and the second Extension Phase visit (Last - EPH2)\n\nThe Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.'}, {'measure': 'Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH1 From Baseline', 'timeFrame': 'Baseline and wk 72', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1)'}, {'measure': 'Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH2 From Baseline', 'timeFrame': 'Baseline and wk 96', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)'}, {'measure': 'Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH1 From Week 48 (or Last Visit on Study)', 'timeFrame': 'Wk 48 (or last available measurement on study), Wk 72', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the last measure on study and the first Extension Phase visit (Last- EPH1)'}, {'measure': 'Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH2 From Week 48 (or Last Visit on Study)', 'timeFrame': 'W 48 (or last available measurement on study), Wk 96', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the last measure on study and the second Extension Phase visit (Last- EPH2)'}, {'measure': 'Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH1 From Baseline', 'timeFrame': 'Baseline and wk 72', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1)\n\nThe Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.'}, {'measure': 'Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH2 From Baseline', 'timeFrame': 'Baseline, Week 96', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)\n\nThe Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.'}, {'measure': 'Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH1 From Week 48 (or Last Visit on Study)', 'timeFrame': 'Week 48 (or last available measurement on study), Week 72', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the last measure on study and the first Extension Phase visit (Last - EPH1)\n\nThe Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.'}, {'measure': 'Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH2 From Week 48 (or Last Visit on Study)', 'timeFrame': 'Wk 48 (or last available measurement on study), Wk 96', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the last measure on study and the second Extension Phase visit (Last - EPH2).\n\nThe Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.'}, {'measure': 'Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH1 From Baseline', 'timeFrame': 'Baseline and wk 72', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1)'}, {'measure': 'Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH2 From Baseline', 'timeFrame': 'Baseline and wk 96', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)'}, {'measure': 'Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH1 From Week 48 (or Last Visit on Study)', 'timeFrame': 'Wk 48 (or last available measurement on study), Wk 72', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the last measure on study and the first Extension Phase visit (Last- EPH1)'}, {'measure': 'Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH2 From Week 48 (or Last Visit on Study)', 'timeFrame': 'Wk 48 (or last available measurement on study), Wk 96', 'description': 'For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).\n\nThis measure shows the difference between the last measure on study and the second Extension Phase visit (Last- EPH2)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tenofovir', 'Emtricitabine', 'Truvada', 'Renal, endocrine, bone changes', 'HIV prevention', 'PrEP'], 'conditions': ['HIV Infection']}, 'referencesModule': {'references': [{'pmid': '28013265', 'type': 'RESULT', 'citation': 'Havens PL, Stephensen CB, Van Loan MD, Schuster GU, Woodhouse LR, Flynn PM, Gordon CM, Pan CG, Rutledge B, Liu N, Wilson CM, Hazra R, Hosek SG, Anderson PL, Seifert SM, Kapogiannis BG, Mulligan K; Adolescent Medicine Trials Network for HIV/AIDS Interventions 117 study team. Decline in Bone Mass With Tenofovir Disoproxil Fumarate/Emtricitabine Is Associated With Hormonal Changes in the Absence of Renal Impairment When Used by HIV-Uninfected Adolescent Boys and Young Men for HIV Preexposure Prophylaxis. Clin Infect Dis. 2017 Feb 1;64(3):317-325. doi: 10.1093/cid/ciw765. Epub 2016 Nov 15.'}, {'pmid': '30280906', 'type': 'DERIVED', 'citation': 'Havens PL, Tamhane A, Stephensen CB, Schuster GU, Gordon CM, Liu N, Wilson CM, Hosek SG, Anderson PL, Kapogiannis BG, Mulligan K. Short Communication: Association of Vitamin D Insufficiency and Protective Tenofovir Diphosphate Concentrations with Bone Toxicity in Adolescent Boys and Young Men Using Tenofovir Disoproxil Fumarate/Emtricitabine for HIV Pre-Exposure Prophylaxis. AIDS Res Hum Retroviruses. 2019 Feb;35(2):123-128. doi: 10.1089/AID.2018.0096. Epub 2018 Nov 5.'}, {'pmid': '30260797', 'type': 'DERIVED', 'citation': 'Havens PL, Long D, Schuster GU, Gordon CM, Price G, Wilson CM, Kapogiannis BG, Mulligan K, Stephensen CB; Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 117 and 109 study teams. Tenofovir disoproxil fumarate appears to disrupt the relationship of vitamin D and parathyroid hormone. Antivir Ther. 2018;23(7):623-628. doi: 10.3851/IMP3269. Epub 2018 Sep 27.'}], 'seeAlsoLinks': [{'url': 'http://www.atnonline.org', 'label': 'ATN Website'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective observational cohort sub-study of subjects enrolled in the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 110 (NCT01772823) or ATN 113 (NCT01769456), which is a prospective interventional trial.', 'detailedDescription': 'This is a prospective observational cohort sub-study of subjects enrolled in the ATN 110 (NCT01772823) or ATN 113 (NCT01769456) study. All subjects will be followed for at least 48 weeks. Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 (NCT01772823) or ATN 113 (NCT01769456) study will be followed for an additional 48 weeks in the Extension Phase of ATN 110 (NCT01772823) or ATN 113 (NCT01769456) and ATN 117 (NCT01769469). The maximum duration of participation will be 96 weeks.\n\nThere is no therapeutic intervention specific to this sub-study, and there are no extra study visits required for participation in this sub-study. Questionnaires will be administered and blood and urine samples for laboratory evaluation of potential emtricitabine (FTC)/tenofovir (TDF) (Truvada®) toxicities will be obtained for this sub-study at visits that are required by the ATN 110 (NCT01772823) or ATN 113 (NCT01769456) study. Measurement of bone mineral density (BMD) and bone mineral content (BMC) by dual-energy X-ray absorptiometry (DXA) scan are planned as a part of the ATN 110 (NCT01772823) and ATN 113 (NCT01769456) studies, and results will be utilized for the analysis in this study. This study does not require extra BMD or BMC measurements.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '22 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals between the ages 15 years 0 days to 22 years 364 days, who are enrolled in ATN 110 (NCT01772823) or ATN 113 (NCT01769456) , and agree to enter this sub-study at the same time they begin ATN 110 or ATN 113.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has been enrolled in ATN 110 (NCT01772823) or ATN 113 (NCT01769456) , and\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n-Subjects exempted from undergoing DXA scans in ATN 110 (NCT01772823) or ATN 113 (NCT01769456) are not eligible to enroll in ATN 117 (NCT01769469).'}, 'identificationModule': {'nctId': 'NCT01769469', 'briefTitle': 'Renal, Endocrine, and Bone Changes in Response to FTC/TDF in Uninfected Young Men Who Have Sex With Men (YMSM).', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Renal, Endocrine, and Bone Changes in Response to Treatment With Coformulated Emtricitabine-Tenofovir for Pre-Exposure HIV Prophylaxis (PrEP) in HIV Uninfected Young Men Who Have Sex With Men.', 'orgStudyIdInfo': {'id': 'ATN 117 Version 2.0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects Enrolled in ATN 110 or ATN 113', 'description': 'A subset of 100 participants who are enrolled in the ATN 110 or ATN 113 study will be recruited for participation in this study. There is no treatment or intervention for this study; however, all subjects will be on daily coformulated tenofovir/emtricitabine (TDF/FTC (Truvada®)) as part of the ATN 110 or ATN 113 study.', 'interventionNames': ['Drug: FTC/TDF (Truvada®)']}], 'interventions': [{'name': 'FTC/TDF (Truvada®)', 'type': 'DRUG', 'otherNames': ['Truvada®'], 'description': 'There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.', 'armGroupLabels': ['Subjects Enrolled in ATN 110 or ATN 113']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hopsital of Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital of Denver", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33101', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Stroger Hospital and the CORE Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Fenway Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hopsital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'St. Jude Childrens Research Hospital', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Peter Havens, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'MACC Fund Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}