Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT00458393
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
2007-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Prevention in Men
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069480', 'term': 'Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}], 'ancestors': [{'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.glidden@ucsf.edu', 'phone': '415-514-8009', 'title': 'David Glidden', 'organization': 'University of California, San Francisco'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up', 'description': 'Adverse events graded by the NIH Division of AIDS grading tables, version 1.0', 'eventGroups': [{'id': 'EG000', 'title': 'TDF/FTC', 'description': 'Daily oral emtricitabine/tenofovir disoproxil fumarate\n\nEmtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate', 'otherNumAtRisk': 1226, 'otherNumAffected': 906, 'seriousNumAtRisk': 1226, 'seriousNumAffected': 92}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Daily oral placebo\n\nPlacebo: Placebo for emtricitabine/tenofovir disoproxil fumarate', 'otherNumAtRisk': 1230, 'otherNumAffected': 937, 'seriousNumAtRisk': 1230, 'seriousNumAffected': 94}], 'otherEvents': [{'term': 'PHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 248, 'numAffected': 248}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 282, 'numAffected': 282}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'PARASITIC INFECTION INTESTINAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 231, 'numAffected': 231}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 216, 'numAffected': 216}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 151, 'numAffected': 151}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 155, 'numAffected': 155}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'BILIRUBIN INCREASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 127, 'numAffected': 127}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 132, 'numAffected': 132}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 109, 'numAffected': 109}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 123, 'numAffected': 123}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'BLOOD GLUCOSE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 109, 'numAffected': 109}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 123, 'numAffected': 123}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'BLOOD PHOSPHORUS DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 122, 'numAffected': 122}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 100, 'numAffected': 100}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 102, 'numAffected': 102}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 107, 'numAffected': 107}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 98, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 92, 'numAffected': 92}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'URETHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 84, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 102, 'numAffected': 102}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 84, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 87, 'numAffected': 87}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'ASPARTATE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 76, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 93, 'numAffected': 93}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 81, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 84, 'numAffected': 84}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'SYPHILIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 82, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 71, 'numAffected': 71}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 73, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 76, 'numAffected': 76}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'SECONDARY SYPHILIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 81, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 64, 'numAffected': 64}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'BLOOD AMYLASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 62, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 57, 'numAffected': 57}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Bone Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'CREATININE INCREASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'SUICIDE ATTEMPT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'SUICIDAL IDEATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'ALT INCREASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'AST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'APPENDICITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'SUICIDAL DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'MAJOR DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'OTHER EVENTS', 'notes': 'EVENTS AFFECTING LESS THAN A TOTAL OF 5 PARTICIPANTS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1226, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 1230, 'numEvents': 29, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'HIV Seroconversion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1224', 'groupId': 'OG000'}, {'value': '1218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TDF/FTC', 'description': 'Daily oral emtricitabine/tenofovir disoproxil fumarate\n\nEmtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Daily oral placebo\n\nPlacebo: Placebo for emtricitabine/tenofovir disoproxil fumarate'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.577', 'ciLowerLimit': '.404', 'ciUpperLimit': '.824', 'pValueComment': 'secondary p-value given.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.105', 'estimateComment': 'Efron correction for ties. Placebo is reference. Results typically quoted as efficacy = 100\\*(1-HR)', 'groupDescription': 'Primary null hypothesis: Relative hazard of 0.7 or less. Secondary null hypothesis: Relative hazard of 1.0 or less.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'stratified by site'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Monthly follow-up through a median of 1.2 years', 'description': 'Confirmed HIV infection', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Excludes participants who were HIV+ at enrollment (2 TDF/FTC, 8 Placebo) and those with no follow-up HIV test (25 TDF/FTC and 22 Placebo).'}, {'type': 'PRIMARY', 'title': 'Grade 1 or Higher Creatinine Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1216', 'groupId': 'OG000'}, {'value': '1217', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TDF/FTC', 'description': 'Daily oral emtricitabine/tenofovir disoproxil fumarate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Daily oral placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.28', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.33', 'ciLowerLimit': '0.79', 'ciUpperLimit': '2.25', 'pValueComment': 'p-value is not adjusted for multiple comparisons, a priori threshold for statistical significance was p \\< 0.05', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'Extensive analysis and methods published in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3966916/'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Duration of follow-up, median 1.2 years', 'description': 'Creatinine which reach grade 1 (mild, 1.1 to 1.3 local upper limit of normal) or higher by the US Division of AIDS grading table (version 1) or a 50% increase in creatinine from the baseline value. The DAIDS table can be found at https://rsc.tech-res.com/docs/default-source/safety/table\\_for\\_grading\\_severity\\_of\\_adult\\_pediatric\\_adverse\\_events.pdf', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants which at least 1 follow-up creatinine value'}, {'type': 'PRIMARY', 'title': 'Grade 3 or Higher Phosphorous Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1225', 'groupId': 'OG000'}, {'value': '1226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TDF/FTC', 'description': 'Daily oral emtricitabine/tenofovir disoproxil fumarate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Daily oral placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.54', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '.57', 'ciUpperLimit': '2.96', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'The entire follow-up period, median 1.2 years', 'description': 'Grade 3 or higher phosphorous toxicity (hypophosphatemia) by the Division of AIDS Grading Table (severe, level at or below 1.9 mg/dL)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with at least 1 follow-up phosphorus value'}, {'type': 'PRIMARY', 'title': 'Grade 2, 3, or 4 Laboratory Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1229', 'groupId': 'OG000'}, {'value': '1226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TDF/FTC', 'description': 'Daily oral emtricitabine/tenofovir disoproxil fumarate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Daily oral placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.50', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.23', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Entire follow-up, median 1.2 years', 'description': 'Number of participants with at least one Grade 2, 3, or 4 laboratory adverse events (moderate, severe of life threatening based one the US Division of AIDS Grading of adverse events, version 1.0). The table can be found at https://rsc.tech-res.com/docs/default-source/safety/table\\_for\\_grading\\_severity\\_of\\_adult\\_pediatric\\_adverse\\_events.pdf', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'At participants with at least one visit with laboratory values post-baseline'}, {'type': 'PRIMARY', 'title': 'Grade 2, 3, or 4 Clinical Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1226', 'groupId': 'OG000'}, {'value': '1230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TDF/FTC', 'description': 'Daily oral emtricitabine/tenofovir disoproxil fumarate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Daily oral placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.92', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.23', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Entire follow-up, median 1.2 years', 'description': 'Number of participants with at least 1 Grade 2, 3, or 4 clinical adverse events (moderate, severe of life threatening based one the US Division of AIDS Grading of adverse events, version 1.0). The table can be found at https://rsc.tech-res.com/docs/default-source/safety/table\\_for\\_grading\\_severity\\_of\\_adult\\_pediatric\\_adverse\\_events.pdf', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'At participants with at least one follow-up visit'}, {'type': 'SECONDARY', 'title': 'Hepatitis Flares Among Hepatitis B Virus (HBV) Infected Persons During and After Chemoprophylaxis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TDF/FTC', 'description': 'Daily oral emtricitabine/tenofovir disoproxil fumarate\n\nEmtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Daily oral placebo\n\nPlacebo: Placebo for emtricitabine/tenofovir disoproxil fumarate'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Null hypothesis of no difference', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.00', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Desc'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Quarterly lab tests through a median follow-up of 1.2 years', 'description': 'A hepatic flare is defined as an increase in alanine transaminase or aspartate transaminase to \\>5 fold upper limit of normal at any visit, or an increase to \\>2.5 fold upper limit of normal for 3 months, within 24 weeks of permanently stopping study drug.\n\nMore details in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4752387/', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Those with chronic active hepatitis B at enrollment.'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Bone Mineral Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TDF/FTC', 'description': 'Daily oral emtricitabine/tenofovir disoproxil fumarate\n\nEmtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Daily oral placebo\n\nPlacebo: Placebo for emtricitabine/tenofovir disoproxil fumarate'}], 'classes': [{'title': 'L1-L4 Spine bone mineral density', 'categories': [{'measurements': [{'value': '-0.59', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Hip bone mineral density', 'categories': [{'measurements': [{'value': '-0.34', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-.91', 'pValueComment': '\\< 0.05 for statistical significance. no adjustment for multiple comparisons', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24.', 'description': '% Change from baseline in bone mineral density (100 \\* \\[(value at 24 weeks- value at baseline)/ (value at baseline)\\]) in in hip and L1-L4 spine by dual-energy x-ray absorptiometry', 'unitOfMeasure': 'percent change from baseline', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants confirmed to be HIV negative at enrollment who consented to participate in the metabolic substudy. Full details in https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/25908682/'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Body Fat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TDF/FTC', 'description': 'Daily oral emtricitabine/tenofovir disoproxil fumarate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Daily oral placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.8', 'ciLowerLimit': '-6.6', 'ciUpperLimit': '-0.95', 'statisticalMethod': 'median regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Percentage Change (100 \\* \\[(value at 24 weeks- value at baseline)/ (value at baseline)\\]) in Body Fat from Baseline by dual-energy x-ray absorptiometry', 'unitOfMeasure': 'percent change from baseline', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the body composition substudy who made a week 24 body scan'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Fasting Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TDF/FTC', 'description': 'Daily oral emtricitabine/tenofovir disoproxil fumarate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Daily oral placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '3.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-9.3', 'ciUpperLimit': '9.3', 'statisticalMethod': 'median regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Percentage Change (Percentage Change (100 \\* \\[(value at 24 weeks- value at baseline)/ (value at baseline)\\]) in Triglycerides from Baseline from a fasting sample.', 'unitOfMeasure': 'percent change from baseline', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the metabolic substudy with a week 24 fast triglyceride value'}, {'type': 'SECONDARY', 'title': 'Percent Change in Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TDF/FTC', 'description': 'Daily oral emtricitabine/tenofovir disoproxil fumarate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Daily oral placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.2', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.19', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-5.5', 'ciUpperLimit': '1.1', 'statisticalMethod': 'median regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Percent change (100 \\* \\[(value at 24 weeks- value at baseline)/ (value at baseline)\\]) in fasting total cholesterol from baseline', 'unitOfMeasure': 'percent change from baseline', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the metabolic substudy with a week 24 fasting cholesterol'}, {'type': 'SECONDARY', 'title': 'Viral Load Among HIV Infected Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TDF/FTC', 'description': 'Daily oral emtricitabine/tenofovir disoproxil fumarate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Daily oral placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.56', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-.18', 'ciUpperLimit': '0.33', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'At the time closest to HIV detection', 'description': 'HIV-RNA in log10 units among HIV infected participants at the time closest to HIV detection', 'unitOfMeasure': 'log RNA copies per ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All HIV infections detected during the study including prior to, during and after study treatment'}, {'type': 'SECONDARY', 'title': 'Among HIV Infected Participants Drug Resistance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TDF/FTC', 'description': 'Daily oral emtricitabine/tenofovir disoproxil fumarate\n\nEmtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Daily oral placebo\n\nPlacebo: Placebo for emtricitabine/tenofovir disoproxil fumarate'}], 'classes': [{'title': 'Infected at Enrollment (prior to randomization)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Infected after Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.00', 'groupDescription': 'Null hypothesis is the proportion of mutations is identical.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'otherAnalysisDescription': 'Detailed resistance data is found at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4176446/'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at the time of HIV acquisition', 'description': 'Genotypic resistance by clinical assays among the seroconverters from baseline to the end of the study treatment period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 2 TDF/FTC seroconversions at enrollment and 48 during follow-up. There were 8 Placebo seroconversions at enrollment and 83 during follow-up.'}, {'type': 'SECONDARY', 'title': 'CD4 Count Among HIV Infected Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TDF/FTC', 'description': 'Daily oral emtricitabine/tenofovir disoproxil fumarate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Daily oral placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '495', 'groupId': 'OG000', 'lowerLimit': '470', 'upperLimit': '520'}, {'value': '502', 'groupId': 'OG001', 'lowerLimit': '483', 'upperLimit': '521'}]}]}], 'analyses': [{'pValue': '0.32', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7', 'ciLowerLimit': '-69', 'ciUpperLimit': '54', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at the time infection was detected', 'description': 'CD4 cell count for HIV infected participants during the trial', 'unitOfMeasure': 'cells per cubic mm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'HIV infected participants during the trial including those HIV+ at baseline'}, {'type': 'SECONDARY', 'title': 'Proportion of Missed Doses by Pill Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '983', 'groupId': 'OG000'}, {'value': '999', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TDF/FTC', 'description': 'Daily oral emtricitabine/tenofovir disoproxil fumarate\n\nEmtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Daily oral placebo\n\nPlacebo: Placebo for emtricitabine/tenofovir disoproxil fumarate'}], 'classes': [{'categories': [{'measurements': [{'value': '0.92', 'groupId': 'OG000', 'lowerLimit': '0.91', 'upperLimit': '0.93'}, {'value': '0.93', 'groupId': 'OG001', 'lowerLimit': '0.92', 'upperLimit': '0.94'}]}]}], 'analyses': [{'pValue': '0.53', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.005', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.01', 'groupDescription': 'Null hypothesis is equal proportion of pills returned', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'At 24 weeks', 'description': 'Estimated proportion of missed doses by pill count (assuming pills taken in unreturned bottles)', 'unitOfMeasure': 'proportion of pills not returned', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Those who bottles returned at the week 24 visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Missed Doses by Estimate During CASI Interview', 'denoms': [{'units': 'Participants', 'counts': [{'value': '884', 'groupId': 'OG000'}, {'value': '902', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TDF/FTC', 'description': 'Daily oral emtricitabine/tenofovir disoproxil fumarate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Daily oral placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '91.0', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '91.2', 'spread': '0.50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.70', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '1.6', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'Detailed methods and results are available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4110718/'}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'Percentage of missed doses by estimate during computer assisted structured interview', 'unitOfMeasure': 'percentage of doses taken', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who answered the adherence question with an estimated adherence on the week 24 computer assisted structured interview'}, {'type': 'SECONDARY', 'title': 'Number of Condomless Sexual Partners With HIV Positive or Unknown Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1091', 'groupId': 'OG000'}, {'value': '1114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TDF/FTC', 'description': 'Daily oral emtricitabine/tenofovir disoproxil fumarate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Daily oral placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'analyses': [{'pValue': '0.99', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0', 'pValueComment': 'Not adjusted for multiple comparisons and the a priori threshold for statistical significance was p \\< 0.05', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'At 24 weeks', 'description': 'Participants self-report of the number of sexual partners with HIV positive or unknown status in the previous 12 weeks with whom they had condomless anal sex', 'unitOfMeasure': 'count', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants interviewed about sexual practices at week 24'}, {'type': 'SECONDARY', 'title': 'Total Number of Sexual Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1091', 'groupId': 'OG000'}, {'value': '1114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TDF/FTC', 'description': 'Daily oral emtricitabine/tenofovir disoproxil fumarate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Daily oral placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '6'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '7'}]}]}], 'analyses': [{'pValue': '0.76', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-.42', 'ciUpperLimit': '.42', 'pValueComment': 'Not adjusted for multiple comparisons, a priori threshold for statistical significance, p \\< 0.05', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'Full details available in the methods section of https://www.ncbi.nlm.nih.gov/pubmed/24367497'}], 'paramType': 'MEDIAN', 'timeFrame': '24 weeks', 'description': 'Self-reported total number of sexual partners in the previous 12 weeks.', 'unitOfMeasure': 'Count', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants interviewed about sexual practices at week 24'}, {'type': 'SECONDARY', 'title': 'Condomless Receptive Anal Intercourse in the Previous 12 Weeks With Any Partners Regardless of Status.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1091', 'groupId': 'OG000'}, {'value': '1114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TDF/FTC', 'description': 'Daily oral emtricitabine/tenofovir disoproxil fumarate\n\nEmtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Daily oral placebo\n\nPlacebo: Placebo for emtricitabine/tenofovir disoproxil fumarate'}], 'classes': [{'categories': [{'measurements': [{'value': '332', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.68', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.008', 'ciLowerLimit': '-0.047', 'ciUpperLimit': '0.030', 'groupDescription': 'Null is no difference between arms', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 24 weeks', 'description': 'Self-reported condomless receptive anal intercourse in the previous 12 weeks with any partners regardless of status.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants interviewed about sexual practices at week 24'}, {'type': 'SECONDARY', 'title': 'Incidence of Confirmed Syphilis During Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1155', 'groupId': 'OG000'}, {'value': '1171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TDF/FTC', 'description': 'Daily oral emtricitabine/tenofovir disoproxil fumarate\n\nEmtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Daily oral placebo\n\nPlacebo: Placebo for emtricitabine/tenofovir disoproxil fumarate'}], 'classes': [{'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.30', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.43', 'groupDescription': 'Null hypothesis of no difference between the arms', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'All Follow-Up median of 1.2 years of follow-up', 'description': 'Number of participants who have at least 1 confirmed syphilis infection during the study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants without active syphilis at baseline with a follow-up syphilis test.'}, {'type': 'SECONDARY', 'title': 'Incidence of HSV-2 During the Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '676', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TDF/FTC', 'description': 'Daily oral emtricitabine/tenofovir disoproxil fumarate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Daily oral placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.41', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '0.8', 'ciUpperLimit': '1.7', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'Details in the manuscript https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3956614/'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Total study follow-up, a median of 1.2 years', 'description': 'Incidence of HSV-2 during the follow-up period among those HIV-2 negative at baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All HSV-2 negative participants with a follow-up HSV-2 test.'}, {'type': 'SECONDARY', 'title': 'Diagnosis of Gonorrhea During the Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1226', 'groupId': 'OG000'}, {'value': '1229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TDF/FTC', 'description': 'Daily oral emtricitabine/tenofovir disoproxil fumarate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Daily oral placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.61', 'ciLowerLimit': '0.34', 'ciUpperLimit': '1.09', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'All of follow-up period, median of 1.2 years', 'description': 'Diagnosis of gonorrhea during the follow-up period by PCR', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with at least one follow-up test for gonorrhea'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TDF/FTC', 'description': 'Daily oral emtricitabine/tenofovir disoproxil fumarate\n\nEmtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Daily oral placebo\n\nPlacebo: Placebo for emtricitabine/tenofovir disoproxil fumarate'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1251'}, {'groupId': 'FG001', 'numSubjects': '1248'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '942'}, {'groupId': 'FG001', 'numSubjects': '953'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '309'}, {'groupId': 'FG001', 'numSubjects': '295'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Relocated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '92'}]}, {'type': 'Sites marked other on the form.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}]}]}], 'recruitmentDetails': 'The study recruited HIV uninfected participants whose sexual practices put them at risk for HIV infection. They were recruited from community clinics.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1251', 'groupId': 'BG000'}, {'value': '1248', 'groupId': 'BG001'}, {'value': '2499', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TDF/FTC', 'description': 'Daily oral emtricitabine/tenofovir disoproxil fumarate\n\nEmtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Daily oral placebo\n\nPlacebo: Placebo for emtricitabine/tenofovir disoproxil fumarate'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1158', 'groupId': 'BG000'}, {'value': '1147', 'groupId': 'BG001'}, {'value': '2305', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '67'}, {'value': '24', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '63'}, {'value': '24', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '67'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male Sex at Birth. Identify Trans', 'categories': [{'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '310', 'groupId': 'BG002'}]}]}, {'title': 'Male Sex at Birth. Identify Female', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'Male Sex at Birth. Identify Male', 'categories': [{'measurements': [{'value': '1081', 'groupId': 'BG000'}, {'value': '1079', 'groupId': 'BG001'}, {'value': '2160', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Ecuador', 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '184', 'groupId': 'BG001'}, {'value': '370', 'groupId': 'BG002'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}, {'title': 'Thailand', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}, {'title': 'Peru', 'categories': [{'measurements': [{'value': '700', 'groupId': 'BG000'}, {'value': '700', 'groupId': 'BG001'}, {'value': '1400', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2499}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-29', 'studyFirstSubmitDate': '2007-04-06', 'resultsFirstSubmitDate': '2016-12-27', 'studyFirstSubmitQcDate': '2007-04-06', 'lastUpdatePostDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-19', 'studyFirstPostDateStruct': {'date': '2007-04-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HIV Seroconversion', 'timeFrame': 'Monthly follow-up through a median of 1.2 years', 'description': 'Confirmed HIV infection'}, {'measure': 'Grade 1 or Higher Creatinine Toxicity', 'timeFrame': 'Duration of follow-up, median 1.2 years', 'description': 'Creatinine which reach grade 1 (mild, 1.1 to 1.3 local upper limit of normal) or higher by the US Division of AIDS grading table (version 1) or a 50% increase in creatinine from the baseline value. The DAIDS table can be found at https://rsc.tech-res.com/docs/default-source/safety/table\\_for\\_grading\\_severity\\_of\\_adult\\_pediatric\\_adverse\\_events.pdf'}, {'measure': 'Grade 3 or Higher Phosphorous Toxicity', 'timeFrame': 'The entire follow-up period, median 1.2 years', 'description': 'Grade 3 or higher phosphorous toxicity (hypophosphatemia) by the Division of AIDS Grading Table (severe, level at or below 1.9 mg/dL)'}, {'measure': 'Grade 2, 3, or 4 Laboratory Adverse Events', 'timeFrame': 'Entire follow-up, median 1.2 years', 'description': 'Number of participants with at least one Grade 2, 3, or 4 laboratory adverse events (moderate, severe of life threatening based one the US Division of AIDS Grading of adverse events, version 1.0). The table can be found at https://rsc.tech-res.com/docs/default-source/safety/table\\_for\\_grading\\_severity\\_of\\_adult\\_pediatric\\_adverse\\_events.pdf'}, {'measure': 'Grade 2, 3, or 4 Clinical Adverse Events', 'timeFrame': 'Entire follow-up, median 1.2 years', 'description': 'Number of participants with at least 1 Grade 2, 3, or 4 clinical adverse events (moderate, severe of life threatening based one the US Division of AIDS Grading of adverse events, version 1.0). The table can be found at https://rsc.tech-res.com/docs/default-source/safety/table\\_for\\_grading\\_severity\\_of\\_adult\\_pediatric\\_adverse\\_events.pdf'}], 'secondaryOutcomes': [{'measure': 'Hepatitis Flares Among Hepatitis B Virus (HBV) Infected Persons During and After Chemoprophylaxis', 'timeFrame': 'Quarterly lab tests through a median follow-up of 1.2 years', 'description': 'A hepatic flare is defined as an increase in alanine transaminase or aspartate transaminase to \\>5 fold upper limit of normal at any visit, or an increase to \\>2.5 fold upper limit of normal for 3 months, within 24 weeks of permanently stopping study drug.\n\nMore details in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4752387/'}, {'measure': 'Percentage Change in Bone Mineral Density', 'timeFrame': 'baseline and week 24.', 'description': '% Change from baseline in bone mineral density (100 \\* \\[(value at 24 weeks- value at baseline)/ (value at baseline)\\]) in in hip and L1-L4 spine by dual-energy x-ray absorptiometry'}, {'measure': 'Percentage Change in Body Fat', 'timeFrame': 'Baseline and Week 24', 'description': 'Percentage Change (100 \\* \\[(value at 24 weeks- value at baseline)/ (value at baseline)\\]) in Body Fat from Baseline by dual-energy x-ray absorptiometry'}, {'measure': 'Percentage Change in Fasting Triglycerides', 'timeFrame': 'Baseline and Week 24', 'description': 'Percentage Change (Percentage Change (100 \\* \\[(value at 24 weeks- value at baseline)/ (value at baseline)\\]) in Triglycerides from Baseline from a fasting sample.'}, {'measure': 'Percent Change in Total Cholesterol', 'timeFrame': 'Baseline and Week 24', 'description': 'Percent change (100 \\* \\[(value at 24 weeks- value at baseline)/ (value at baseline)\\]) in fasting total cholesterol from baseline'}, {'measure': 'Viral Load Among HIV Infected Participants', 'timeFrame': 'At the time closest to HIV detection', 'description': 'HIV-RNA in log10 units among HIV infected participants at the time closest to HIV detection'}, {'measure': 'Among HIV Infected Participants Drug Resistance', 'timeFrame': 'at the time of HIV acquisition', 'description': 'Genotypic resistance by clinical assays among the seroconverters from baseline to the end of the study treatment period'}, {'measure': 'CD4 Count Among HIV Infected Participants', 'timeFrame': 'at the time infection was detected', 'description': 'CD4 cell count for HIV infected participants during the trial'}, {'measure': 'Proportion of Missed Doses by Pill Count', 'timeFrame': 'At 24 weeks', 'description': 'Estimated proportion of missed doses by pill count (assuming pills taken in unreturned bottles)'}, {'measure': 'Percentage of Missed Doses by Estimate During CASI Interview', 'timeFrame': 'Week 24', 'description': 'Percentage of missed doses by estimate during computer assisted structured interview'}, {'measure': 'Number of Condomless Sexual Partners With HIV Positive or Unknown Status', 'timeFrame': 'At 24 weeks', 'description': 'Participants self-report of the number of sexual partners with HIV positive or unknown status in the previous 12 weeks with whom they had condomless anal sex'}, {'measure': 'Total Number of Sexual Partners', 'timeFrame': '24 weeks', 'description': 'Self-reported total number of sexual partners in the previous 12 weeks.'}, {'measure': 'Condomless Receptive Anal Intercourse in the Previous 12 Weeks With Any Partners Regardless of Status.', 'timeFrame': 'At 24 weeks', 'description': 'Self-reported condomless receptive anal intercourse in the previous 12 weeks with any partners regardless of status.'}, {'measure': 'Incidence of Confirmed Syphilis During Follow-Up', 'timeFrame': 'All Follow-Up median of 1.2 years of follow-up', 'description': 'Number of participants who have at least 1 confirmed syphilis infection during the study'}, {'measure': 'Incidence of HSV-2 During the Follow-up Period', 'timeFrame': 'Total study follow-up, a median of 1.2 years', 'description': 'Incidence of HSV-2 during the follow-up period among those HIV-2 negative at baseline'}, {'measure': 'Diagnosis of Gonorrhea During the Follow-up Period', 'timeFrame': 'All of follow-up period, median of 1.2 years', 'description': 'Diagnosis of gonorrhea during the follow-up period by PCR'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'Chemoprophylaxis', 'Hepatitis', 'Viral human hepatitis', 'HIV Seronegativity'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '21091279', 'type': 'RESULT', 'citation': 'Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV; iPrEx Study Team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010 Dec 30;363(27):2587-99. doi: 10.1056/NEJMoa1011205. Epub 2010 Nov 23.'}, {'pmid': '37969014', 'type': 'DERIVED', 'citation': 'Zivich PN, Cole SR, Edwards JK, Glidden DV, Das M, Shook-Sa BE, Shao Y, Mehrotra ML, Adimora AA, Eron JJ. HIV Prevention Among Men Who Have Sex With Men: Tenofovir Alafenamide Combination Preexposure Prophylaxis Versus Placebo. J Infect Dis. 2024 Apr 12;229(4):1123-1130. doi: 10.1093/infdis/jiad507.'}, {'pmid': '31192894', 'type': 'DERIVED', 'citation': 'Mehrotra ML, Westreich D, McMahan VM, Glymour MM, Geng E, Grant RM, Glidden DV. Baseline Characteristics Explain Differences in Effectiveness of Randomization to Daily Oral TDF/FTC PrEP Between Transgender Women and Cisgender Men Who Have Sex With Men in the iPrEx Trial. J Acquir Immune Defic Syndr. 2019 Jul 1;81(3):e94-e98. doi: 10.1097/QAI.0000000000002037. No abstract available.'}, {'pmid': '29415175', 'type': 'DERIVED', 'citation': 'Glidden DV, Mulligan K, McMahan V, Anderson PL, Guanira J, Chariyalertsak S, Buchbinder SP, Bekker LG, Schechter M, Grinsztejn B, Grant RM. Metabolic Effects of Preexposure Prophylaxis With Coformulated Tenofovir Disoproxil Fumarate and Emtricitabine. Clin Infect Dis. 2018 Jul 18;67(3):411-419. doi: 10.1093/cid/ciy083.'}, {'pmid': '28639995', 'type': 'DERIVED', 'citation': 'Glidden DV, Mulligan K, McMahan V, Anderson PL, Guanira J, Chariyalertsak S, Buchbinder SP, Bekker LG, Schechter M, Grinsztejn B, Grant RM. Brief Report: Recovery of Bone Mineral Density After Discontinuation of Tenofovir-Based HIV Pre-exposure Prophylaxis. J Acquir Immune Defic Syndr. 2017 Oct 1;76(2):177-182. doi: 10.1097/QAI.0000000000001475.'}, {'pmid': '27658870', 'type': 'DERIVED', 'citation': 'Gandhi M, Glidden DV, Mayer K, Schechter M, Buchbinder S, Grinsztejn B, Hosek S, Casapia M, Guanira J, Bekker LG, Louie A, Horng H, Benet LZ, Liu A, Grant RM. Association of age, baseline kidney function, and medication exposure with declines in creatinine clearance on pre-exposure prophylaxis: an observational cohort study. Lancet HIV. 2016 Nov;3(11):e521-e528. doi: 10.1016/S2352-3018(16)30153-9. Epub 2016 Aug 31.'}, {'pmid': '27572401', 'type': 'DERIVED', 'citation': 'Castillo-Mancilla J, Seifert S, Campbell K, Coleman S, McAllister K, Zheng JH, Gardner EM, Liu A, Glidden DV, Grant R, Hosek S, Wilson CM, Bushman LR, MaWhinney S, Anderson PL. Emtricitabine-Triphosphate in Dried Blood Spots as a Marker of Recent Dosing. Antimicrob Agents Chemother. 2016 Oct 21;60(11):6692-6697. doi: 10.1128/AAC.01017-16. Print 2016 Nov.'}, {'pmid': '26797207', 'type': 'DERIVED', 'citation': 'Glidden DV, Amico KR, Liu AY, Hosek SG, Anderson PL, Buchbinder SP, McMahan V, Mayer KH, David B, Schechter M, Grinsztejn B, Guanira J, Grant RM. Symptoms, Side Effects and Adherence in the iPrEx Open-Label Extension. Clin Infect Dis. 2016 May 1;62(9):1172-7. doi: 10.1093/cid/ciw022. Epub 2016 Jan 20.'}, {'pmid': '25908682', 'type': 'DERIVED', 'citation': 'Mulligan K, Glidden DV, Anderson PL, Liu A, McMahan V, Gonzales P, Ramirez-Cardich ME, Namwongprom S, Chodacki P, de Mendonca LM, Wang F, Lama JR, Chariyalertsak S, Guanira JV, Buchbinder S, Bekker LG, Schechter M, Veloso VG, Grant RM; Preexposure Prophylaxis Initiative Study Team. Effects of Emtricitabine/Tenofovir on Bone Mineral Density in HIV-Negative Persons in a Randomized, Double-Blind, Placebo-Controlled Trial. Clin Infect Dis. 2015 Aug 15;61(4):572-80. doi: 10.1093/cid/civ324. Epub 2015 Apr 23.'}, {'pmid': '25230290', 'type': 'DERIVED', 'citation': 'Liu A, Glidden DV, Anderson PL, Amico KR, McMahan V, Mehrotra M, Lama JR, MacRae J, Hinojosa JC, Montoya O, Veloso VG, Schechter M, Kallas EG, Chariyalerstak S, Bekker LG, Mayer K, Buchbinder S, Grant R; iPrEx Study team. Patterns and correlates of PrEP drug detection among MSM and transgender women in the Global iPrEx Study. J Acquir Immune Defic Syndr. 2014 Dec 15;67(5):528-37. doi: 10.1097/QAI.0000000000000351.'}, {'pmid': '24740633', 'type': 'DERIVED', 'citation': 'Liegler T, Abdel-Mohsen M, Bentley LG, Atchison R, Schmidt T, Javier J, Mehrotra M, Eden C, Glidden DV, McMahan V, Anderson PL, Li P, Wong JK, Buchbinder S, Guanira JV, Grant RM; iPrEx Study Team. HIV-1 drug resistance in the iPrEx preexposure prophylaxis trial. J Infect Dis. 2014 Oct 15;210(8):1217-27. doi: 10.1093/infdis/jiu233. Epub 2014 Apr 16.'}, {'pmid': '24613084', 'type': 'DERIVED', 'citation': 'Buchbinder SP, Glidden DV, Liu AY, McMahan V, Guanira JV, Mayer KH, Goicochea P, Grant RM. HIV pre-exposure prophylaxis in men who have sex with men and transgender women: a secondary analysis of a phase 3 randomised controlled efficacy trial. Lancet Infect Dis. 2014 Jun;14(6):468-75. doi: 10.1016/S1473-3099(14)70025-8. Epub 2014 Mar 7.'}, {'pmid': '23435697', 'type': 'DERIVED', 'citation': 'Amico KR, Mansoor LE, Corneli A, Torjesen K, van der Straten A. Adherence support approaches in biomedical HIV prevention trials: experiences, insights and future directions from four multisite prevention trials. AIDS Behav. 2013 Jul;17(6):2143-55. doi: 10.1007/s10461-013-0429-9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether daily use of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) can prevent HIV infection in men who also receive HIV counseling, condoms, and treatment for other sexually transmitted infections (STIs).', 'detailedDescription': "The Joint United Nations Programme on AIDS estimates that 14,000 persons are newly infected with HIV every day worldwide; one half of these infections occur in people between the ages of 15 and 24. New infections occur despite widespread awareness of the modes of HIV transmission and the protection afforded by condom use. Effective interventions for HIV prevention are urgently needed. This study will evaluate the safety and efficacy of chemoprophylaxis for HIV prevention in men who have sex with men (MSM) who are at high risk for HIV infection despite using condoms, receiving HIV counseling, and receiving treatment for STIs, particularly hepatitis B virus (HBV) infection. A daily combination dose of emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) has been selected for evaluation because it has a well-established safety record in previous studies and was demonstrated to be effective for HIV prevention in primate models. These medications have long half-lives that allow daily dosing and do not have known interactions with hormonal contraception, methadone, or tuberculosis therapies.\n\nOnce on the study drug, participants will be followed for a variable length of time, starting within 4 weeks of their screening visit and lasting up to 144 weeks. All participants will be followed for at least 8 weeks after stopping study drug. Participants who are reactive to a Hepatitis B surface antigen (HBsAg) test will be followed for hepatic flares for 16 additional weeks for a total of 24 weeks after stopping study drug. If enrolled in the optional substudy of bone mineral density, fat distribution, and fasting lipids, the participant will be asked to return for one additional visit 24 weeks after stopping study drug. Participants who HIV seroconvert during their participation will also be followed until the end of the study.\n\nAll study visits will be at 4 week intervals. At study entry, high risk, HIV uninfected MSM will be randomly assigned to receive either daily FTC/TDF or placebo, in addition to standard HIV counseling, condoms, and sexually transmitted infection (STI) management. The study will closely monitor biological and behavioral safety, including careful analysis of drug resistance, kidney and liver function, and risk behavior.\n\nAt the screening visit, participants will undergo HIV antibody and HBV testing, a medical history, a medical exam, blood and urine collection, risk behavior assessment, and STI testing. At study entry, participants will be given study medication; tested for HCV; and offered the HBV vaccine, if applicable. At all study visits, there will be HIV antibody testing, pill counts, adherence checks, study medication distribution, HIV counseling, and condom distribution. A medical history and blood will be taken on selected visits, along with STI testing and treatment if needed. Testing and treatment of STIs will be provided at no cost to the participant.\n\nAll study participants will be encouraged to join a substudy that will assess interactions between HBV infection, bone mineral density and fat distribution, and immune function. If enrolled in the substudy, the participant will be asked to return for one additional visit 24 weeks after stopping the study medication. All participants in the substudy will undergo dual energy x-ray absorptiometry (DEXA) scans, and HIV infected participants will undergo additional blood collection.\n\nSites will have the option of participating in the following four substudies:\n\nThe Hair Substudy: Participants who are receiving FTC/TDF will be eligible to enroll. At each 12-week follow-up study visit, hair samples will be collected and questionnaires will be completed.\n\nThe Urine Substudy: For all participants who elect to enroll in this substudy, additional testing will occur on blood and urine samples collected at each 24-week follow-up visit. An additional urine collection will occur 8 weeks after participants stop receiving FTC/TDF.\n\nThe Semen Substudy: Participants who seroconvert during the study may elect to participate in this substudy. One semen sample will be collected at participants' next study visit when plasma viral load testing is performed.\n\nThe Gonorrhea and Chlamydia Substudy: Participants in this substudy will undergo rectal and oropharyngeal swab procedures and urine collection at the 24-week study visit.\n\nAfter the randomized phase ends, if the daily oral FTC/TDF arm is shown to be beneficial and safe, participants will be given the option of participating in an open label extension phase. During this extension phase, study participants will receive daily oral open-label FTC/TDF, in addition to standard counseling, condoms, and STI management."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male sex (at birth)\n* HIV uninfected\n* Age having reached the local age of consent\n* High risk for HIV infection including any of the following: 1) No condom use during anal intercourse with a male HIV-positive partner or a male partner of unknown HIV status during the last 6 months; (2) anal intercourse with more than 3 male sex partners during the last 6 months; (3) exchange of money, gifts, shelter, or drugs for anal sex with a male partner during the last 6 months; (4) sex with a male partner and STI diagnosis during the last 6 months or at screening, or (5) sexual partner of an HIV-infected man with whom condoms are not consistently used in the last 6 months.\n* Able to provide a street address of residence for themselves and one personal contact who would know their whereabouts during the study period\n* Healthy enough to work, as indicated by score of 80 or greater on the Karnofsky scale\n* Certain laboratory values\n* A urine dipstick with a negative or trace result for both glucose and protein within 28 days of enrollment.\n* Ability to understand and local language for which an informed consent form has been approved by a local IRB and registered with the study sponsor.\n\nInclusion Criteria for Open-Label Extension:\n\n* Participated in a randomized, placebo-controlled, PrEP trail\n* Has been unblinded\n* Has provided informed consent\n\nExclusion Criteria:\n\n* Previously diagnosed active and serious infections, including tuberculosis infection, osteomyelitis, or infections requiring parenteral antibiotic therapy\n* Active clinically significant medical problems including heart disease (e.g., symptoms of ischemia, congestive heart failure, arrhythmia), lung disease (steroid-dependent chronic obstructive pulmonary disease), diabetes requiring hypoglycemic medication, or previously diagnosed cancer expected to require further treatment\n* Acute HBV infection at the screening visit or presence of treatment indications for hepatitis B based on local practice standards; or clinical signs of hepatic cirrhosis\n* History of pathological bone fractures not related to trauma\n* Receiving ongoing therapy with certain HIV/AIDS-related medications or other medications as determined by the investigator\n* Definitely or possibly received an anti-HIV vaccine while participating in a blinded clinical trial\n* Current alcohol or drug use that, in the opinion of the investigator, may interfere with the study\n* Current participation in a clinical trial or cohort study other than sub-studies of this protocol\n* Any condition at enrollment that, in the opinion of the investigator, would make participation in the study unsafe or would interfere with the study\n* Sites may utilize additional criteria that restrict enrollment to a subset of people who meet the protocol-defined enrollment criteria.\n\nExclusion Criteria for Open-Label Extension:\n\n\\- Site leadership believes participant will have difficulty completing requirements'}, 'identificationModule': {'nctId': 'NCT00458393', 'acronym': 'iPrEx', 'briefTitle': 'Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Prevention in Men', 'nctIdAliases': ['NCT00350324'], 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Chemoprophylaxis for HIV Prevention in Men', 'orgStudyIdInfo': {'id': 'CO-US-104-0288'}, 'secondaryIdInfos': [{'id': '10445', 'type': 'REGISTRY', 'domain': 'DAIDS ES'}, {'id': '1U01AI064002', 'link': 'https://reporter.nih.gov/quickSearch/1U01AI064002', 'type': 'NIH'}, {'id': 'iPrEx', 'type': 'OTHER', 'domain': 'Study team'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TDF/FTC', 'description': 'Drug. Daily oral tablet of co-formulated 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate (TDF/FTC).', 'interventionNames': ['Drug: daily TDF/FTC']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Drug. Daily oral placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'daily TDF/FTC', 'type': 'DRUG', 'otherNames': ['truvada'], 'description': 'daily oral medication', 'armGroupLabels': ['TDF/FTC']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'daily oral medication', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94102', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco Dept. of Public Health iPrEx CRS', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Stroger Hospital of Cook County/Core Center IPREX CRS', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Fenway Community Health iPrEx CRS', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '21040-900', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'IPEC/FIOCRUZ iPrEx CRS', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '21941.590', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Projeto Praca Onze, Universidade Federal do Rio de Janeiro iPrEx CRS', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '05403', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade de Sao Paulo iPrEx CRS', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Guayaquil', 'state': 'Guayas', 'country': 'Ecuador', 'facility': 'Fundación Ecuatoriana Equidad, Guayaquil, iPrEx CRS', 'geoPoint': {'lat': -2.19616, 'lon': -79.88621}}, {'city': 'Iquitos', 'state': 'Maynas', 'country': 'Peru', 'facility': 'Asociación Civil Selva Amazónica, Iquitos, iPrEx CRS', 'geoPoint': {'lat': -3.74814, 'lon': -73.2529}}, {'city': 'Lima', 'country': 'Peru', 'facility': 'Investigaciones Médicas en Salud (INMENSA), Lince, iPrEx CRS', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '7925', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Desmond Tutu HIV Ctr. iPrEx CRS', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '50200', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Research Institute for Health Sciences iPrEx CRS', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}], 'overallOfficials': [{'name': 'Robert M. Grant, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'J. David Gladstone Institutes, University of California San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': 'Bill and Melinda Gates Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}