Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT01403051
Status:
COMPLETED
Last Update Posted:
2018-10-12
First Post:
2011-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
High Dose Vitamin D and Calcium for Bone Health in Individuals Initiating HAART
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068257', 'term': 'Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}, {'id': 'D002119', 'term': 'Calcium Carbonate'}, {'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D008903', 'term': 'Minerals'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ACTGCT.Gov@s-3.com', 'phone': '(301) 628-3313', 'title': 'ACTG ClinicalTrials.gov Coordinator', 'organization': 'ACTG Network Coordinating Center, Social and Scientific Systems, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From first study treatment to week 48', 'description': "Adverse events from patients' first study treatment date to off study date.\n\nmedDRA version 16.1", 'eventGroups': [{'id': 'EG000', 'title': 'Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF', 'description': 'The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).\n\nVitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.\n\nCalcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.', 'otherNumAtRisk': 81, 'otherNumAffected': 60, 'seriousNumAtRisk': 81, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF', 'description': 'The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).\n\nPlacebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.\n\nPlacebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.', 'otherNumAtRisk': 86, 'otherNumAffected': 70, 'seriousNumAtRisk': 86, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Alanine aminotransferase abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Aspartate aminotransferase abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Blood albumin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Blood calcium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Blood glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Blood phosphorus decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 23}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Low density lipoprotein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'seriousEvents': [{'term': 'Mallory-Weiss syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Lyme disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Meningitis aseptic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Depression suicidal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Drug reaction with eosinophilia and systemic symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Percent Change From Baseline in Bone Mineral Density (BMD) at Total Hip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF', 'description': 'The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).\n\nVitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.\n\nCalcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}, {'id': 'OG001', 'title': 'Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF', 'description': 'The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).\n\nPlacebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.\n\nPlacebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.46', 'groupId': 'OG000', 'lowerLimit': '-3.16', 'upperLimit': '-0.40'}, {'value': '-3.19', 'groupId': 'OG001', 'lowerLimit': '-5.12', 'upperLimit': '-1.02'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '2-sided test with type I error rate of 5%, not adjusted for multiple comparisons.', 'groupDescription': 'The study was sized to have 80% power to detect a 2 % difference in BMD of the hip from baseline to week 48.', 'statisticalMethod': 'Stratified Wilcoxon rank sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified Wilcoxon rank sum test for differences between the two treatment groups, stratified by the screening 25-OH vitamin (\\<=20 vs. \\>20 ng/mL)'}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 0 and 48', 'description': 'The efficacy endpoint is the percent change from baseline to week 48 in bone mineral density (BMD) at total hip (as measured by DXA scan)', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis is intent-to-treat (ITT) which is limited to eligible subjects who have baseline and week 48 follow-up regardless of treatment change or discontinuation.'}, {'type': 'SECONDARY', 'title': 'The Percent Change From Baseline in Bone Mineral Density (BMD) at Spine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF', 'description': 'The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).\n\nVitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.\n\nCalcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}, {'id': 'OG001', 'title': 'Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF', 'description': 'The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).\n\nPlacebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.\n\nPlacebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.41', 'groupId': 'OG000', 'lowerLimit': '-3.78', 'upperLimit': '0.00'}, {'value': '-2.91', 'groupId': 'OG001', 'lowerLimit': '-4.84', 'upperLimit': '-1.06'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 0 and 48', 'description': 'The percent change from baseline to week 48 in bone mineral density (BMD) at spine as measured by DXA scan', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis is intent-to-treat (ITT) which is limited to eligible subjects who have baseline and week 48 follow-up regardless of treatment change or discontinuation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Primary Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF', 'description': 'The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).\n\nVitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.\n\nCalcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}, {'id': 'OG001', 'title': 'Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF', 'description': 'The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)\n\nPlacebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.\n\nPlacebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first study treatment to week 48', 'description': 'Primary adverse events include all SAEs defined according to ICH guidelines and targeted protocol events, which include all diagnoses of hypercalcemia, hypophoatemia, and nephrolithiasis as well as signs and symptoms grade 2 or higher that may be associated with hypercalcemia and all laboratory toxicities grade 2 or higher defined by the 2004 DAIDS grading table', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled subjects including subjects excluded from efficacy analysis due to eligibility violation.'}, {'type': 'SECONDARY', 'title': 'The Change in Total 25-OH Vitamin D Level From Baseline to Weeks 24 and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF', 'description': 'The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).\n\nVitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.\n\nCalcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}, {'id': 'OG001', 'title': 'Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF', 'description': 'The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)\n\nPlacebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.\n\nPlacebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}], 'classes': [{'title': 'change from baseline to week 24', 'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000', 'lowerLimit': '15.0', 'upperLimit': '38.0'}, {'value': '-0.8', 'groupId': 'OG001', 'lowerLimit': '-5.9', 'upperLimit': '4.9'}]}]}, {'title': 'change from baseline to week 48', 'categories': [{'measurements': [{'value': '24.2', 'groupId': 'OG000', 'lowerLimit': '14.3', 'upperLimit': '35.8'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '-6.1', 'upperLimit': '4.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 0, 24, and 48', 'description': 'Changes in total 25-OH vitamin D from baseline to weeks 24 and 48 ( \\[week 24-baseline\\] and \\[week 48 - baseline\\], respectively).\n\nTotal 25-OH vitamin D is the sum of vitamin 25-OH D2 and D3 levels. All 25-OH vitamin D2 or D3 values below the lower limit of 1.25 ng/mL were imputed to 0 ng/mL', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.\n\nn=71 and 74 for changes at week 24, n=65 and 68 for changes at week 48.'}, {'type': 'SECONDARY', 'title': 'The Changes From Baseline in IL-6 to Weeks 24 and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF', 'description': 'The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).\n\nVitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.\n\nCalcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}, {'id': 'OG001', 'title': 'Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF', 'description': 'The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)\n\nPlacebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.\n\nPlacebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}], 'classes': [{'title': 'change from baseline to week 24', 'categories': [{'measurements': [{'value': '-0.05', 'groupId': 'OG000', 'lowerLimit': '-0.23', 'upperLimit': '0.11'}, {'value': '-0.04', 'groupId': 'OG001', 'lowerLimit': '-0.23', 'upperLimit': '0.14'}]}]}, {'title': 'change from baseline to week 48', 'categories': [{'measurements': [{'value': '-0.07', 'groupId': 'OG000', 'lowerLimit': '-0.24', 'upperLimit': '0.12'}, {'value': '-0.03', 'groupId': 'OG001', 'lowerLimit': '-0.23', 'upperLimit': '0.10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 0, 24 and 48', 'description': 'Interleukin 6 (IL-6) changes from baseline to weeks 24 and 48 ( \\[week 24-baseline\\] and \\[week 48 - baseline\\], respectively).', 'unitOfMeasure': 'log10 pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.\n\nn=66 and 68 for changes at week 24, n=58 and 62 for changes at week 48.'}, {'type': 'SECONDARY', 'title': 'The Changes From Baseline in sCD14 to Weeks 24 and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF', 'description': 'The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).\n\nVitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.\n\nCalcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}, {'id': 'OG001', 'title': 'Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF', 'description': 'The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)\n\nPlacebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.\n\nPlacebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}], 'classes': [{'title': 'change from baseline to week 24', 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '-0.08', 'upperLimit': '0.15'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-0.07', 'upperLimit': '0.14'}]}]}, {'title': 'change from baseline to week 48', 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '-0.05', 'upperLimit': '0.16'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '-0.06', 'upperLimit': '0.14'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 0, 24 and 48', 'description': 'Soluble cluster of differentiation 14 (sCD14) changes from baseline to weeks 24 and 48 ( \\[week 24-baseline\\] and \\[week 48 - baseline\\], respectively).', 'unitOfMeasure': 'log10 ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.\n\nn=68 and 68 for changes at week 24, n=62 and 63 for changes at week 48.'}, {'type': 'SECONDARY', 'title': 'The Changes From Baseline in P1NP to Weeks 24 and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF', 'description': 'The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).\n\nVitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.\n\nCalcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}, {'id': 'OG001', 'title': 'Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF', 'description': 'The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)\n\nPlacebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.\n\nPlacebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}], 'classes': [{'title': 'change from baseline to week 24', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '26'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '38'}]}]}, {'title': 'change from baseline to week 48', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '29'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '39'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 0, 24 and 48', 'description': 'P1NP (marker of bone formation) changes from baseline to weeks 24 and 48 ( \\[week 24-baseline\\] and \\[week 48 - baseline\\], respectively).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.\n\nn=72 and 77 for changes at week 24, n=66 and 72 for changes at week 48.'}, {'type': 'SECONDARY', 'title': 'The Changes From Baseline in CTX to Weeks 24 and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF', 'description': 'The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).\n\nVitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.\n\nCalcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}, {'id': 'OG001', 'title': 'Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF', 'description': 'The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)\n\nPlacebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.\n\nPlacebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}], 'classes': [{'title': 'change from baseline to week 24', 'categories': [{'measurements': [{'value': '0.11', 'groupId': 'OG000', 'lowerLimit': '-0.01', 'upperLimit': '0.27'}, {'value': '0.22', 'groupId': 'OG001', 'lowerLimit': '0.11', 'upperLimit': '0.35'}]}]}, {'title': 'change from baseline to week 48', 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '-0.04', 'upperLimit': '0.25'}, {'value': '0.14', 'groupId': 'OG001', 'lowerLimit': '0.05', 'upperLimit': '0.32'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 0, 24 and 48', 'description': 'CTX (marker of bone resorption) changes from baseline to weeks 24 and 48 ( \\[week 24-baseline\\] and \\[week 48 - baseline\\], respectively).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.\n\nn=72 and 77 for changes at week 24, n=66 and 72 for changes at week 48.'}, {'type': 'SECONDARY', 'title': 'The Changes From Baseline in HOMA-IR to Weeks 24 and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF', 'description': 'The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).\n\nVitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.\n\nCalcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}, {'id': 'OG001', 'title': 'Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF', 'description': 'The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)\n\nPlacebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.\n\nPlacebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}], 'classes': [{'title': 'change from baseline to week 24', 'categories': [{'measurements': [{'value': '0.17', 'groupId': 'OG000', 'lowerLimit': '-0.21', 'upperLimit': '0.91'}, {'value': '0.39', 'groupId': 'OG001', 'lowerLimit': '-0.11', 'upperLimit': '1.15'}]}]}, {'title': 'change from baseline to week 48', 'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG000', 'lowerLimit': '-0.26', 'upperLimit': '1.11'}, {'value': '0.26', 'groupId': 'OG001', 'lowerLimit': '-0.44', 'upperLimit': '0.79'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 0, 24 and 48', 'description': 'Homeostatic model assessment insulin resistance (HOMA-IR) changes from baseline to weeks 24 and 48 ( \\[week 24-baseline\\] and \\[week 48 - baseline\\], respectively).', 'unitOfMeasure': 'HOMA-IR', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.\n\nn=69 and 73 for changes at week 24, n=64 and 69 for changes at week 48.'}, {'type': 'SECONDARY', 'title': 'The Changes From Baseline in Fasting Total Cholesterol to Weeks 24 and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF', 'description': 'The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).\n\nVitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.\n\nCalcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}, {'id': 'OG001', 'title': 'Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF', 'description': 'The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)\n\nPlacebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.\n\nPlacebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}], 'classes': [{'title': 'change from baseline to week 24', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '-4', 'upperLimit': '29'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '31'}]}]}, {'title': 'change from baseline to week 48', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '-6', 'upperLimit': '28'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '37'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 0, 24 and 48', 'description': 'Fasting total cholesterol changes from baseline to weeks 24 and 48 ( \\[week 24-baseline\\] and \\[week 48 - baseline\\], respectively).', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.\n\nn=74 and 80 for changes at week 24, n=68 and 73 for changes at week 48.'}, {'type': 'SECONDARY', 'title': 'The Changes From Baseline in Fasting LDL to Weeks 24 and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF', 'description': 'The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).\n\nVitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.\n\nCalcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}, {'id': 'OG001', 'title': 'Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF', 'description': 'The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)\n\nPlacebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.\n\nPlacebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}], 'classes': [{'title': 'change from baseline to week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-10', 'upperLimit': '17'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '-11', 'upperLimit': '20'}]}]}, {'title': 'change from baseline to week 48', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '-9', 'upperLimit': '14'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '-14', 'upperLimit': '27'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 0, 24 and 48', 'description': 'Fasting LDL cholesterol changes from baseline to weeks 24 and 48 ( \\[week 24-baseline\\] and \\[week 48 - baseline\\], respectively).', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.\n\nn=70 and 72 for changes at week 24, n=65 and 67 for changes at week 48.'}, {'type': 'SECONDARY', 'title': 'The Changes From Baseline in Urinary Phosphate Excretion to Weeks 24 and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF', 'description': 'The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).\n\nVitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.\n\nCalcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}, {'id': 'OG001', 'title': 'Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF', 'description': 'The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)\n\nPlacebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.\n\nPlacebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}], 'classes': [{'title': 'change from baseline to week 24', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '-2.4', 'upperLimit': '3.1'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-1.8', 'upperLimit': '3.8'}]}]}, {'title': 'change from baseline to week 48', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-1.8', 'upperLimit': '3.7'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '-1.9', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 0, 24 and 48', 'description': 'Fractional excretion of phosphate changes from baseline to weeks 24 and 48 ( \\[week 24-baseline\\] and \\[week 48 - baseline\\], respectively).\n\nFractional Excretion of Phosphate (in %) is defined as:\n\n\\[Urine Phosphate x Serum Creatinine\\] / \\[Urine Creatinine x Serum Phosphate\\] x 100%', 'unitOfMeasure': 'percent', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.\n\nn=58 and 70 for changes at week 24, n=59 and 69 for changes at week 48.'}, {'type': 'SECONDARY', 'title': 'The Changes From Baseline in CD4 to Weeks 4, 12, 24 and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF', 'description': 'The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).\n\nVitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.\n\nCalcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}, {'id': 'OG001', 'title': 'Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF', 'description': 'The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)\n\nPlacebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.\n\nPlacebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}], 'classes': [{'title': 'change from baseline to week 4', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '146'}, {'value': '60', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '102'}]}]}, {'title': 'change from baseline to week 12', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '170'}, {'value': '106', 'groupId': 'OG001', 'lowerLimit': '60', 'upperLimit': '216'}]}]}, {'title': 'change from baseline to week 24', 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '195'}, {'value': '136', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '219'}]}]}, {'title': 'change from baseline to week 48', 'categories': [{'measurements': [{'value': '192', 'groupId': 'OG000', 'lowerLimit': '113', 'upperLimit': '305'}, {'value': '201', 'groupId': 'OG001', 'lowerLimit': '108', 'upperLimit': '292'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 0, 4, 12, 24 and 48', 'description': 'Total CD4 count changes from baseline to weeks 4, 12, 24 and 48 \\[week 4/12/24/48 - baseline\\].', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.\n\nn=78 and 86 for changes at week 4, n=77 and 85 for changes at week 4, n=76 and 84 for changes at week 24, n=69 and 80 for changes at week 48.'}, {'type': 'SECONDARY', 'title': 'The Changes From Baseline in iPTH to Weeks 24 and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF', 'description': 'The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).\n\nVitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.\n\nCalcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}, {'id': 'OG001', 'title': 'Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF', 'description': 'The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)\n\nPlacebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.\n\nPlacebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}], 'classes': [{'title': 'change from baseline to week 24', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '-3.8', 'upperLimit': '5.7'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '-0.8', 'upperLimit': '9.3'}]}]}, {'title': 'change from baseline to week 48', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '6.1'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '12.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 0, 24 and 48', 'description': 'iPTH (Parathyroid Hormone, intact) changes from baseline to weeks 24 and 48 ( \\[week 24-baseline\\] and \\[week 48 - baseline\\], respectively).', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.\n\nn=72 and 77 for changes at week 24, n=66 and 72 for changes at week 48.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF', 'description': 'The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).\n\nVitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.\n\nCalcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}, {'id': 'FG001', 'title': 'Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF', 'description': 'The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)\n\nPlacebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.\n\nPlacebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '86'}]}, {'type': 'Initiated Study Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '86'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'A5280 opened under version 1.0 on September 15, 2011, and the first subject was randomized on September 26, 2011. Accrual to the study closed on March 2, 2012, with a total of 167 subjects enrolled from 39 sites within the US.', 'preAssignmentDetails': 'Subjects were randomized with a 1:1 ratio at enrollment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF', 'description': 'The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).\n\nVitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.\n\nCalcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}, {'id': 'BG001', 'title': 'Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF', 'description': 'The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).\n\nPlacebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.\n\nPlacebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks\n\nAtripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000', 'lowerLimit': '28', 'upperLimit': '47'}, {'value': '31', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '44'}, {'value': '33', 'groupId': 'BG002', 'lowerLimit': '26', 'upperLimit': '46'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White Non-Hispanic', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}, {'title': 'Black Non-Hispanic', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic (Regardless of Race)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'Asian, Pacific Islander', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'American Indian, Alaskan Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HIV-1 RNA level', 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'groupId': 'BG000', 'lowerLimit': '4.1', 'upperLimit': '5.1'}, {'value': '4.5', 'groupId': 'BG001', 'lowerLimit': '4.0', 'upperLimit': '5.1'}, {'value': '4.5', 'groupId': 'BG002', 'lowerLimit': '4.1', 'upperLimit': '5.1'}]}]}], 'paramType': 'MEDIAN', 'description': 'Entry HIV-RNA level (log10 copies/mL)', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'CD4 count', 'classes': [{'categories': [{'measurements': [{'value': '339', 'groupId': 'BG000', 'lowerLimit': '230', 'upperLimit': '500'}, {'value': '342', 'groupId': 'BG001', 'lowerLimit': '232', 'upperLimit': '454'}, {'value': '341', 'groupId': 'BG002', 'lowerLimit': '230', 'upperLimit': '490'}]}]}], 'paramType': 'MEDIAN', 'description': 'Entry total CD4 count (cells/mm3)', 'unitOfMeasure': 'cells/mm3', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': 'Includes only subjects who did not have eligibility violations'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-11', 'studyFirstSubmitDate': '2011-07-25', 'resultsFirstSubmitDate': '2014-02-05', 'studyFirstSubmitQcDate': '2011-07-25', 'lastUpdatePostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-02-05', 'studyFirstPostDateStruct': {'date': '2011-07-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Percent Change From Baseline in Bone Mineral Density (BMD) at Total Hip', 'timeFrame': 'Weeks 0 and 48', 'description': 'The efficacy endpoint is the percent change from baseline to week 48 in bone mineral density (BMD) at total hip (as measured by DXA scan)'}], 'secondaryOutcomes': [{'measure': 'The Percent Change From Baseline in Bone Mineral Density (BMD) at Spine', 'timeFrame': 'Weeks 0 and 48', 'description': 'The percent change from baseline to week 48 in bone mineral density (BMD) at spine as measured by DXA scan'}, {'measure': 'Number of Participants With Primary Adverse Events', 'timeFrame': 'From first study treatment to week 48', 'description': 'Primary adverse events include all SAEs defined according to ICH guidelines and targeted protocol events, which include all diagnoses of hypercalcemia, hypophoatemia, and nephrolithiasis as well as signs and symptoms grade 2 or higher that may be associated with hypercalcemia and all laboratory toxicities grade 2 or higher defined by the 2004 DAIDS grading table'}, {'measure': 'The Change in Total 25-OH Vitamin D Level From Baseline to Weeks 24 and 48', 'timeFrame': 'Weeks 0, 24, and 48', 'description': 'Changes in total 25-OH vitamin D from baseline to weeks 24 and 48 ( \\[week 24-baseline\\] and \\[week 48 - baseline\\], respectively).\n\nTotal 25-OH vitamin D is the sum of vitamin 25-OH D2 and D3 levels. All 25-OH vitamin D2 or D3 values below the lower limit of 1.25 ng/mL were imputed to 0 ng/mL'}, {'measure': 'The Changes From Baseline in IL-6 to Weeks 24 and 48', 'timeFrame': 'Weeks 0, 24 and 48', 'description': 'Interleukin 6 (IL-6) changes from baseline to weeks 24 and 48 ( \\[week 24-baseline\\] and \\[week 48 - baseline\\], respectively).'}, {'measure': 'The Changes From Baseline in sCD14 to Weeks 24 and 48', 'timeFrame': 'Weeks 0, 24 and 48', 'description': 'Soluble cluster of differentiation 14 (sCD14) changes from baseline to weeks 24 and 48 ( \\[week 24-baseline\\] and \\[week 48 - baseline\\], respectively).'}, {'measure': 'The Changes From Baseline in P1NP to Weeks 24 and 48', 'timeFrame': 'Weeks 0, 24 and 48', 'description': 'P1NP (marker of bone formation) changes from baseline to weeks 24 and 48 ( \\[week 24-baseline\\] and \\[week 48 - baseline\\], respectively).'}, {'measure': 'The Changes From Baseline in CTX to Weeks 24 and 48', 'timeFrame': 'Weeks 0, 24 and 48', 'description': 'CTX (marker of bone resorption) changes from baseline to weeks 24 and 48 ( \\[week 24-baseline\\] and \\[week 48 - baseline\\], respectively).'}, {'measure': 'The Changes From Baseline in HOMA-IR to Weeks 24 and 48', 'timeFrame': 'Weeks 0, 24 and 48', 'description': 'Homeostatic model assessment insulin resistance (HOMA-IR) changes from baseline to weeks 24 and 48 ( \\[week 24-baseline\\] and \\[week 48 - baseline\\], respectively).'}, {'measure': 'The Changes From Baseline in Fasting Total Cholesterol to Weeks 24 and 48', 'timeFrame': 'Weeks 0, 24 and 48', 'description': 'Fasting total cholesterol changes from baseline to weeks 24 and 48 ( \\[week 24-baseline\\] and \\[week 48 - baseline\\], respectively).'}, {'measure': 'The Changes From Baseline in Fasting LDL to Weeks 24 and 48', 'timeFrame': 'Weeks 0, 24 and 48', 'description': 'Fasting LDL cholesterol changes from baseline to weeks 24 and 48 ( \\[week 24-baseline\\] and \\[week 48 - baseline\\], respectively).'}, {'measure': 'The Changes From Baseline in Urinary Phosphate Excretion to Weeks 24 and 48', 'timeFrame': 'Weeks 0, 24 and 48', 'description': 'Fractional excretion of phosphate changes from baseline to weeks 24 and 48 ( \\[week 24-baseline\\] and \\[week 48 - baseline\\], respectively).\n\nFractional Excretion of Phosphate (in %) is defined as:\n\n\\[Urine Phosphate x Serum Creatinine\\] / \\[Urine Creatinine x Serum Phosphate\\] x 100%'}, {'measure': 'The Changes From Baseline in CD4 to Weeks 4, 12, 24 and 48', 'timeFrame': 'Weeks 0, 4, 12, 24 and 48', 'description': 'Total CD4 count changes from baseline to weeks 4, 12, 24 and 48 \\[week 4/12/24/48 - baseline\\].'}, {'measure': 'The Changes From Baseline in iPTH to Weeks 24 and 48', 'timeFrame': 'Weeks 0, 24 and 48', 'description': 'iPTH (Parathyroid Hormone, intact) changes from baseline to weeks 24 and 48 ( \\[week 24-baseline\\] and \\[week 48 - baseline\\], respectively).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['HIV-1 Infection']}, 'referencesModule': {'references': [{'pmid': '31085814', 'type': 'DERIVED', 'citation': 'Yin MT, Chan ES, Brown TT, Kinslow J, Martinson J, Landay A, Melbourne KM, Ribaudo HJ, Overton ET; A5280 Study Team. Vitamin D does not modulate immune-mediated bone loss during ART initiation. Antivir Ther. 2019;24(5):355-362. doi: 10.3851/IMP3316.'}, {'pmid': '28832406', 'type': 'DERIVED', 'citation': 'Yin MT, Chan ES, Brown TT, Tebas P, McComsey GA, Melbourne KM, Napoli A, Hardin WR, Ribaudo HJ, Overton ET; A5280 Study Team. Racial differences in calculated bioavailable vitamin D with vitamin D/calcium supplementation. AIDS. 2017 Nov 13;31(17):2337-2344. doi: 10.1097/QAD.0000000000001621.'}, {'pmid': '26075752', 'type': 'DERIVED', 'citation': 'Overton ET, Chan ES, Brown TT, Tebas P, McComsey GA, Melbourne KM, Napoli A, Hardin WR, Ribaudo HJ, Yin MT. Vitamin D and Calcium Attenuate Bone Loss With Antiretroviral Therapy Initiation: A Randomized Trial. Ann Intern Med. 2015 Jun 16;162(12):815-24. doi: 10.7326/M14-1409.'}]}, 'descriptionModule': {'briefSummary': 'This study was done with people who were infected with HIV and needed to start treatment for their HIV disease. The purpose of this study is to see if taking vitamin D and calcium will help prevent the bone loss that sometimes happens when people start HIV treatment. For this study, the following HIV treatment (or HAART) were provided in the form of a single tablet that contains three different drugs: efavirenz/emtricitabine/tenofovir (EFV/FTC/TDF). These drugs are approved by the FDA to treat HIV infection. The HIV treatment provided is common for people who are taking HIV drugs for the first time. The risks seen with this HIV treatment are the same that you would encounter when taking these drugs outside of the study. The lists of risks of this HIV treatment are included in this document because the drugs are provided by the study, not because the drugs are being tested. The purpose of the study is only to look at the impact of high doses of vitamin D and calcium in preventing bone loss. There are no study objectives related to HIV treatment (EFV/FTC/TDF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* HIV-1 infection\n* No evidence of any exclusionary resistance mutations based on results from any genotype assay from any laboratory that has a CLIA (Clinical Laboratory Improvement Amendments) certification or its equivalent. Results must be available from testing any time in the past or must be obtained prior to entry and reviewed by the site investigator.\n* ARV drug-naïve (\\<=10 days of ART at any time prior to entry) and no ARV drugs taken within the past 30 days.\n* CD4+ cell count of any value obtained within 90 days prior to study entry at any laboratory that has a CLIA certification or its equivalent.\n* HIV-1 RNA \\>1000 copies/mL obtained within 90 days prior to study entry at any laboratory that has a CLIA certification or its equivalent.\n* Certain laboratory values obtained within 30 days prior to entry (as indicated in section 4.1.6 of the protocol.\n* Serum calcium \\< 10.5 mg/dL within 30 days prior to entry.\n* For women of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to initiating study medications.\n* Subjects must refrain from participating in a conception process (i.e., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) and if participating in sexual activity that could lead to pregnancy, the subject/partner must use at least two of the reliable forms of contraceptive listed in section 4.1.9 of the protocol.\n* 25-OH vitamin D \\>=10 ng/mL and \\<75 ng/mL.\n* Ability and willingness of subject or legally authorized representative to provide informed consent.\n\nExclusion Criteria:\n\n* Current or prior use of bisphosphonate therapy.\n* Use of vitamin D supplements greater than 800 IU/day within 30 days prior to entry.\n* Use of calcium supplements greater than 500 mg/day within 30 days prior to entry.\n* Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulations.\n* Any oral, intravenous, or inhaled steroids within the 30 days prior to enrollment(intranasal steroid use is allowed).\n* Use of androgenic hormones or growth hormones.\n* Receipt of systemic cytotoxic chemotherapy within 30 days prior to entry.\n* Pregnancy or currently breastfeeding.\n* Documentation of acute opportunistic infections within 30 days prior to entry.\n* Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to entry.\n* Weight \\>300 lbs (exceeds weight limit of DXA scanners).\n* History of nephrolithiasis (kidney stones).\n* History of osteoporosis (as documented by DXA scan) or fragility fracture.\n* Clinically active thyroid disease (use of thyroid hormone replacement therapy permitted but TSH must be in normal range).\n* Current imprisonment or involuntary incarceration in a medical facility for psychiatric illness.\n* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n* Any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study."}, 'identificationModule': {'nctId': 'NCT01403051', 'briefTitle': 'High Dose Vitamin D and Calcium for Bone Health in Individuals Initiating HAART', 'organization': {'class': 'NETWORK', 'fullName': 'Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections'}, 'officialTitle': 'A Prospective, Randomized, Double-Blind Phase II Trial of High-Dose Vitamin D and Calcium for Bone Health in HIV-Infected Individuals Initiating Highly Active Antiretroviral Therapy (HAART)', 'orgStudyIdInfo': {'id': 'ACTG A5280'}, 'secondaryIdInfos': [{'id': '1U01AI068636', 'link': 'https://reporter.nih.gov/quickSearch/1U01AI068636', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: EFV/FTC/TDF plus vitamin D3 and calcium carbonate', 'description': 'Participants were administered FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla), calcium carbonate and vitamin D3 4000 IU.', 'interventionNames': ['Drug: EFV/FTC/TDF', 'Drug: Calcium Carbonate', 'Drug: Vitamin D3']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: EFV/FTC/TDF plus vitamin D placebo and calcium placebo', 'description': 'Participants were administered FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla), a placebo for calcium carbonate, and a placebo for vitamin D3.', 'interventionNames': ['Drug: EFV/FTC/TDF', 'Drug: Placebo for calcium carbonate', 'Drug: Placebo for vitamin D3']}], 'interventions': [{'name': 'EFV/FTC/TDF', 'type': 'DRUG', 'otherNames': ['Atripla'], 'description': 'FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.', 'armGroupLabels': ['Arm A: EFV/FTC/TDF plus vitamin D3 and calcium carbonate', 'Arm B: EFV/FTC/TDF plus vitamin D placebo and calcium placebo']}, {'name': 'Calcium Carbonate', 'type': 'DRUG', 'description': 'Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.', 'armGroupLabels': ['Arm A: EFV/FTC/TDF plus vitamin D3 and calcium carbonate']}, {'name': 'Vitamin D3', 'type': 'DRUG', 'description': 'One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.', 'armGroupLabels': ['Arm A: EFV/FTC/TDF plus vitamin D3 and calcium carbonate']}, {'name': 'Placebo for calcium carbonate', 'type': 'DRUG', 'description': 'A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks', 'armGroupLabels': ['Arm B: EFV/FTC/TDF plus vitamin D placebo and calcium placebo']}, {'name': 'Placebo for vitamin D3', 'type': 'DRUG', 'description': 'A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.', 'armGroupLabels': ['Arm B: EFV/FTC/TDF plus vitamin D placebo and calcium placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Therapeutics CRS (5801)', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Usc Crs (1201)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA CARE Center CRS (601)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford CRS (501)', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Ucsd, Avrc Crs (701)', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Ucsf Aids Crs (801)', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor-UCLA Med. Ctr. CRS (603)', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital CRS (6101)', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University CRS (GU CRS) (1008)', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Ponce de Leon Ctr. CRS (5802)', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University CRS (2701)', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center (2702)', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'IHV Baltimore Treatment CRS (4651)', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital ACTG CRS (101)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hosp. ACTG CRS (107)", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Med. Ctr., ACTG CRS (103)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University CRS (2101)', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'New Jersey Medical School-Adult Clinical Research Ctr. CRS (31477)', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Cornell CRS (7804)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NY Univ. HIV/AIDS CRS (401)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'HIV Prevention & Treatment CRS (30329)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'AIDS Care CRS (1108)', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester ACTG CRS (1101)', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '10457', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Bronx-Lebanon Hosp. Ctr. CRS (31469)', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Unc Aids Crs (3201)', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center Adult CRS (1601)', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27401', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Regional Center for Infectious Disease, Wendover Medical Center CRS (3203)', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Univ. of Cincinnati CRS (2401)', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case CRS (2501)', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'MetroHealth CRS (2503)', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State Univ. AIDS CRS (2301)', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hosp. of the Univ. of Pennsylvania CRS (6201)', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pittsburgh CRS (1001)', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'The Miriam Hosp. ACTG CRS (2951)', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Therapeutics CRS (3652)', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75208', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Trinity Health and Wellness Center CRS (31443)', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston AIDS Research Team CRS (31473)', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington AIDS CRS (1401)', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '00935', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Puerto Rico-AIDS CRS (5401)', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Edgar (Turner) Overton, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Alabama Therapeutics CRS'}, {'name': 'Michael T Yin, MD, MS', 'role': 'STUDY_CHAIR', 'affiliation': 'HIV Prevention & Treatment CRS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}