Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-02-25 @ 11:04 PM
Study NCT ID:
NCT00625404
Status:
COMPLETED
Last Update Posted:
2018-07-26
First Post:
2008-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
FEM-PrEP (Truvada®): Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Malawi', 'Zimbabwe']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}], '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'}, {'id': 'D000068698', 'term': 'Tenofovir'}], 'ancestors': [{'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': 'jdeese@fhi360.org', 'phone': '919-544-7040', 'title': 'Jennifer Deese, Principal Investigator', 'phoneExt': '11292', 'organization': 'FHI 360'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'These data are from the safety population, which is a subset of the intent to treat (ITT) population, excluding those participants found to have been HIV infected at enrollment and participants who never received study product, returned all product unused, or never returned for a follow-up visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Truvada Arm', 'description': 'Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).', 'otherNumAtRisk': 1025, 'otherNumAffected': 761, 'seriousNumAtRisk': 1025, 'seriousNumAffected': 33}, {'id': 'EG001', 'title': 'Placebo Arm', 'description': 'Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.', 'otherNumAtRisk': 1033, 'otherNumAffected': 749, 'seriousNumAtRisk': 1033, 'seriousNumAffected': 23}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Exomphalos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Otorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Abnormal vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 52, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 33, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 27, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 38, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Typhoid fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 25, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 21, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dysentery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Peptic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hyperphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Rectal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Local swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 33, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pruritus allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Allergic cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Allergic 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'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'joint contracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'abortion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'foetal distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'premature rupture of the membranes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'removal of foreign body', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1033, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'HIV Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1024', 'groupId': 'OG000'}, {'value': '1032', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada Arm', 'description': 'The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '3.25', 'upperLimit': '6.63'}, {'value': '35', 'groupId': 'OG001', 'lowerLimit': '3.47', 'upperLimit': '6.93'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.59', 'ciUpperLimit': '1.52', 'groupDescription': 'Hazard ratio (HR) for HIV infection based on proportional hazards model, stratified on site. Study was designed to have 90% power to reject the null hypothesis that the HR for infection is \\> 0.3', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Cumulative HIV infection between enrollment and 52 weeks', 'description': 'HIV Seroconversion, with time to infection refined based on PCR results obtained from stored specimens.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who made at least one follow-up visit and were not HIV-positive at enrollment were included in the analysis population'}, {'type': 'PRIMARY', 'title': 'Confirmed Grade 2 or Higher Serum Creatinine Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1021', 'groupId': 'OG000'}, {'value': '1033', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada Arm', 'description': 'Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.45', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Log-rank test for difference in rate of grade 2 or higher creatinine, based on time to first event.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'cumulative toxicity through 52 weeks of product use and 4 weeks post product', 'description': 'Repeat specimens were collected to confirm chemistry toxicities. Grade 2 or higher serum creatinine toxicity was defined as ≥1.4 times the upper limit of normal', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population consisted of all women who were randomized and who had at least one follow-up visit and did not return all of their product un-used. Only women assessed for a particular safety outcome were included in analysis of that outcome.'}, {'type': 'PRIMARY', 'title': 'Frequency of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1025', 'groupId': 'OG000'}, {'value': '1033', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada Arm', 'description': 'The Safety Population, a subset of the ITT Population, excludes participants who never received study product, returned all product unused, or never returned for a follow-up visit. Analyses were performed by randomly assigned treatment group.'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'The Safety Population, a subset of the ITT Population, excludes participants who never received study product, returned all product unused, or never returned for a follow-up visit. Analyses were performed by randomly assigned treatment group.'}], 'classes': [{'categories': [{'measurements': [{'value': '2257', 'groupId': 'OG000'}, {'value': '2384', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10-26 months per site', 'description': 'The total number of adverse events in the placebo and Truvada arms during and within 4 weeks after study product administration.', 'unitOfMeasure': 'Number of adverse events', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population, a subset of the ITT Population, excludes participants who never received study product, returned all product unused, or never returned for a follow-up visit. Analyses were performed by randomly assigned treatment group.'}, {'type': 'PRIMARY', 'title': 'Confirmed Grade 3 or Higher Reduction in Phosphorus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1021', 'groupId': 'OG000'}, {'value': '1033', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada Arm', 'description': 'Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.59', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Log-rank test for difference in rates between groups', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Through 52 weeks on product and 4 weeks post-product', 'description': 'Repeat specimens were collected to confirm chemistry toxicities. Grade 3 phosphorus reduction was defined as ≤2.4mg/dL', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Confirmed Grade 3 or Higher ALT Elevation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1021', 'groupId': 'OG000'}, {'value': '1033', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada Arm', 'description': 'Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.79', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Log-rank test for difference in rates between groups', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Through 52 weeks on product and 4 weeks post-product', 'description': 'Grade 3 or higher ALT elevation was defined as ≥ 2.6 times the upper limit of normal', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Confirmed Grade 3 or Higher AST Elevation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1021', 'groupId': 'OG000'}, {'value': '1033', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada Arm', 'description': 'Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.62', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Log-rank test for difference in rates between groups', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Through 52 weeks on product and 4 weeks post-product', 'description': 'Grade 3 or higher AST elevation was defined as ≥ 2.6 times the upper limit of normal', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma HIV RNA Level (HIV-1 Viral Load)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada Arm', 'description': 'Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.40', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '4.37', 'spread': '1.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.89', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.03', 'groupDescription': 't-test for difference on viral loads', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LOG_MEAN', 'timeFrame': 'up to 16 weeks', 'description': 'Viral load at the time of HIV detection, HIV conversion and through 16 weeks', 'unitOfMeasure': 'log copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '68 women who became infected post-enrollment were included in viral load analyses. Only 48 of these women (27 on Truvada and 21 on placebo) contributed a specimen sample for analysis at the 16-weeks post seroconversion visit'}, {'type': 'SECONDARY', 'title': 'CD4+ T-cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada Arm', 'description': 'Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.'}], 'classes': [{'categories': [{'measurements': [{'value': '579.3', 'spread': '318.2', 'groupId': 'OG000'}, {'value': '601.4', 'spread': '318.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.82', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '22.1', 'groupDescription': 't-test for difference in mean CD-4 counts', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 16 weeks', 'description': 'CD4+ T-cell Count at the Time of HIV Seroconversion through 16 weeks', 'unitOfMeasure': 'cells/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'FTC and/or Tenofovir Resistance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada Arm', 'description': 'Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 52 weeks', 'description': 'Genotypic resistance to FTC and/or tenofovir at the time of HIV diagnosis and 4 weeks later. If resistance was present, testing was repeated at weeks 12, 24, 36 and 52 as necessary (resistance testing will stop if no resistance is detected).\n\nparticipants were classified as having resistance if they had one or more visits in which resistance was detected, even if the resistance became undetectable over time.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All women who seroconverted were assessed for possible resistance.'}, {'type': 'SECONDARY', 'title': 'Pregnancy Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada Arm', 'description': 'Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 60 weeks', 'description': 'Reported complications during pregnancy, including spontaneous abortion, vaginal or uterine bleeding, emergency c-section and other complications', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Women becoming pregnant during regular follow-up in the study (70 in Truvada group and 45 in placebo group)'}, {'type': 'SECONDARY', 'title': 'Pill Counts and Participant Report of Adherence to Once-daily Pill Taking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1024', 'groupId': 'OG000'}, {'value': '1032', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada Arm', 'description': 'Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '89', 'spread': '0.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 52 weeks', 'description': 'Pill counts and participant report of adherence to once-daily pill taking reported as mean days study product could have been used according to pill counts', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who completed at least one follow-up visit, excluding women found to have been infected at enrollment'}, {'type': 'SECONDARY', 'title': 'Participant Report of Change in Number of Sexual Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '977', 'groupId': 'OG000'}, {'value': '989', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada Arm', 'description': 'Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.60', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '-0.13', 'spread': '0.79', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '11'}]}]}], 'analyses': [{'pValue': '0.73', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '.01', 'groupDescription': 't-test for difference in change in number of sexual partners over time', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 52 weeks', 'description': 'Difference in mean number of reported sexual partners between final study visit and enrollment visit', 'unitOfMeasure': 'mean number of sexual partners', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Women reporting on sexual behavior during follow-up'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Truvada Arm', 'description': 'Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).'}, {'id': 'FG001', 'title': 'Placebo Arm', 'description': 'Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1062'}, {'groupId': 'FG001', 'numSubjects': '1058'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '855'}, {'groupId': 'FG001', 'numSubjects': '885'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '207'}, {'groupId': 'FG001', 'numSubjects': '173'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1062', 'groupId': 'BG000'}, {'value': '1058', 'groupId': 'BG001'}, {'value': '2120', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Truvada Arm', 'description': 'Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.'}, {'id': 'BG001', 'title': 'Placebo Arm', 'description': 'Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.'}, {'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': '1062', 'groupId': 'BG000'}, {'value': '1058', 'groupId': 'BG001'}, {'value': '2120', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23', 'spread': '18-35', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '35'}, {'value': '23', 'spread': '18-35', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '35'}, {'value': '23', 'spread': '18-35', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '35'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1062', 'groupId': 'BG000'}, {'value': '1058', 'groupId': 'BG001'}, {'value': '2120', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-28', 'studyFirstSubmitDate': '2008-02-19', 'resultsFirstSubmitDate': '2013-12-09', 'studyFirstSubmitQcDate': '2008-02-26', 'lastUpdatePostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-03-11', 'studyFirstPostDateStruct': {'date': '2008-02-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HIV Infection', 'timeFrame': 'Cumulative HIV infection between enrollment and 52 weeks', 'description': 'HIV Seroconversion, with time to infection refined based on PCR results obtained from stored specimens.'}, {'measure': 'Confirmed Grade 2 or Higher Serum Creatinine Toxicity', 'timeFrame': 'cumulative toxicity through 52 weeks of product use and 4 weeks post product', 'description': 'Repeat specimens were collected to confirm chemistry toxicities. Grade 2 or higher serum creatinine toxicity was defined as ≥1.4 times the upper limit of normal'}, {'measure': 'Frequency of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration', 'timeFrame': '10-26 months per site', 'description': 'The total number of adverse events in the placebo and Truvada arms during and within 4 weeks after study product administration.'}, {'measure': 'Confirmed Grade 3 or Higher Reduction in Phosphorus', 'timeFrame': 'Through 52 weeks on product and 4 weeks post-product', 'description': 'Repeat specimens were collected to confirm chemistry toxicities. Grade 3 phosphorus reduction was defined as ≤2.4mg/dL'}, {'measure': 'Confirmed Grade 3 or Higher ALT Elevation', 'timeFrame': 'Through 52 weeks on product and 4 weeks post-product', 'description': 'Grade 3 or higher ALT elevation was defined as ≥ 2.6 times the upper limit of normal'}, {'measure': 'Confirmed Grade 3 or Higher AST Elevation', 'timeFrame': 'Through 52 weeks on product and 4 weeks post-product', 'description': 'Grade 3 or higher AST elevation was defined as ≥ 2.6 times the upper limit of normal'}], 'secondaryOutcomes': [{'measure': 'Plasma HIV RNA Level (HIV-1 Viral Load)', 'timeFrame': 'up to 16 weeks', 'description': 'Viral load at the time of HIV detection, HIV conversion and through 16 weeks'}, {'measure': 'CD4+ T-cell Count', 'timeFrame': 'Up to 16 weeks', 'description': 'CD4+ T-cell Count at the Time of HIV Seroconversion through 16 weeks'}, {'measure': 'FTC and/or Tenofovir Resistance', 'timeFrame': 'up to 52 weeks', 'description': 'Genotypic resistance to FTC and/or tenofovir at the time of HIV diagnosis and 4 weeks later. If resistance was present, testing was repeated at weeks 12, 24, 36 and 52 as necessary (resistance testing will stop if no resistance is detected).\n\nparticipants were classified as having resistance if they had one or more visits in which resistance was detected, even if the resistance became undetectable over time.'}, {'measure': 'Pregnancy Complications', 'timeFrame': 'up to 60 weeks', 'description': 'Reported complications during pregnancy, including spontaneous abortion, vaginal or uterine bleeding, emergency c-section and other complications'}, {'measure': 'Pill Counts and Participant Report of Adherence to Once-daily Pill Taking', 'timeFrame': 'Up to 52 weeks', 'description': 'Pill counts and participant report of adherence to once-daily pill taking reported as mean days study product could have been used according to pill counts'}, {'measure': 'Participant Report of Change in Number of Sexual Partners', 'timeFrame': 'Up to 52 weeks', 'description': 'Difference in mean number of reported sexual partners between final study visit and enrollment visit'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Aspartate Aminotransferase (AST)', 'Alanine Aminotransferase (ALT)', 'HIV', 'HIV Prevention', 'Oral PrEP', 'Truvada', 'women', 'Tenofovir', 'TDF', 'FTC', 'emtricitabine', 'hepatitis', 'Pre-exposure Prophylaxis (PrEP)', 'HIV Seronegativity'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Lut Van Damme, M.D., Amy Corneli, Ph.D. and Douglas Taylor, Ph.D. New England Journal of Medicine 367: 411-422, 2012'}, {'pmid': '25539648', 'type': 'DERIVED', 'citation': 'Mandala J, Nanda K, Wang M, De Baetselier I, Deese J, Lombaard J, Owino F, Malahleha M, Manongi R, Taylor D, Van Damme L. Liver and renal safety of tenofovir disoproxil fumarate in combination with emtricitabine among African women in a pre-exposure prophylaxis trial. BMC Pharmacol Toxicol. 2014 Dec 24;15:77. doi: 10.1186/2050-6511-15-77.'}, {'pmid': '25503265', 'type': 'DERIVED', 'citation': 'Grant RM, Liegler T, Defechereux P, Kashuba AD, Taylor D, Abdel-Mohsen M, Deese J, Fransen K, De Baetselier I, Crucitti T, Bentley G, Agingu W, Ahmed K, Damme LV. Drug resistance and plasma viral RNA level after ineffective use of oral pre-exposure prophylaxis in women. AIDS. 2015 Jan 28;29(3):331-7. doi: 10.1097/QAD.0000000000000556.'}, {'pmid': '25459097', 'type': 'DERIVED', 'citation': 'Todd CS, Deese J, Wang M, Hubacher D, Steiner MJ, Otunga S, Van Damme L; FEM-PrEP Study Group. Sino-implant (II)(R) continuation and effect of concomitant tenofovir disoproxil fumarate-emtricitabine use on plasma levonorgestrel concentrations among women in Bondo, Kenya. Contraception. 2015 Mar;91(3):248-52. doi: 10.1016/j.contraception.2014.10.008. Epub 2014 Oct 22.'}, {'pmid': '22784040', 'type': 'DERIVED', 'citation': "Van Damme L, Corneli A, Ahmed K, Agot K, Lombaard J, Kapiga S, Malahleha M, Owino F, Manongi R, Onyango J, Temu L, Monedi MC, Mak'Oketch P, Makanda M, Reblin I, Makatu SE, Saylor L, Kiernan H, Kirkendale S, Wong C, Grant R, Kashuba A, Nanda K, Mandala J, Fransen K, Deese J, Crucitti T, Mastro TD, Taylor D; FEM-PrEP Study Group. Preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2012 Aug 2;367(5):411-22. doi: 10.1056/NEJMoa1202614. Epub 2012 Jul 11."}], 'seeAlsoLinks': [{'url': 'http://ghr.nlm.nih.gov/condition/complement-factor-i-deficiency', 'label': 'Genetics Home Reference for complement factor I deficiency'}, {'url': 'http://www.nlm.nih.gov/medlineplus/hivaids.html', 'label': 'MedlinePlus: AIDS'}, {'url': 'http://www.nlm.nih.gov/medlineplus/hepatitis.html', 'label': 'MedlinePlus: Hepatitis'}, {'url': 'http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=0000057114&QV1=N-OCTADECANOIC+ACID', 'label': 'Drug Information: n-Octadecanoic acid'}, {'url': 'http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=0001592230&QV1=CALCIUM+STEARATE', 'label': 'Drug Information: Calcium stearate'}, {'url': 'http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=0007047849&QV1=ALUMINUM+MONOSTEARATE', 'label': 'Drug Information : Aluminum monostearate'}, {'url': 'http://clinicaltrials.gov/ct2/info/fdalinks', 'label': 'U.S. FDA Resources'}]}, 'descriptionModule': {'briefSummary': "This Phase III, double-blind, randomized, placebo-controlled trial enrolled HIV-negative women from 4 sites in 3 countries (Kenya, Tanzania, South Africa). The study's purpose was to investigate the safety and effectiveness of a once-daily Truvada® pill (compared with placebo) in preventing HIV among HIV-uninfected women at risk of becoming infected through sexual intercourse.\n\nThe study population included HIV-antibody-negative women between the ages of 18-35 who were at risk of HIV acquisition through sexual intercourse. Each participant was randomized to take either a daily single oral tablet of Truvada®, which is a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg), or an identical placebo.\n\nAfter enrollment, each participant was followed every four weeks. All participants were followed for an additional eight weeks after study drug was stopped. Incidence rates of HIV infection were compared between the two groups (active drug and placebo) using the intent-to-treat principle.", 'detailedDescription': "This Phase III, double-blind, randomized, placebo-controlled trial enrolled HIV-negative women from 4 sites in 3 countries (Kenya, Tanzania, South Africa). The study's purpose was to investigate the safety and effectiveness of a once-daily Truvada® pill (compared with placebo) in preventing HIV among HIV-uninfected women at risk of becoming infected through sexual intercourse.\n\nThe study population included HIV-antibody-negative women between the ages of 18-35 who were at risk of HIV acquisition through sexual intercourse. Each participant was randomized to take either a daily single oral tablet of Truvada®, which is a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg), or an identical placebo. All participants received risk reduction counseling and condoms. Women had to be using a study-approved effective non-barrier contraceptive method at the time of enrollment and were asked to do so for the whole period they were on study drug. They received contraceptive counseling throughout the study. Any diagnosed, treatable sexually transmitted infection was treated free of charge.\n\nAfter enrollment, each participant was followed every four weeks. All participants were followed for an additional eight weeks after study drug was stopped. Participants at risk for Hepatitis B Virus (HBV) flare were followed every four weeks for 12 weeks after stopping study product. Participants who acquired HIV infection during the study stopped taking the study drug at the time of HIV diagnosis, and will be followed for 52 weeks post diagnosis and were referred for care and treatment. Participants who became pregnant stopped taking the study drug but continued follow-up visits. Incidence rates of HIV infection were compared between the two groups (active drug and placebo) using the intent-to-treat principle."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Willing and able (see criterion 2) to provide written informed consent to be screened for and to participate in the trial\n2. Able to answer a percentage of informed consent screening (75%) and enrollment (100%) comprehension quiz questions correctly\n3. Between 18-35 years old, inclusive\n4. At higher risk of becoming HIV infected\n5. Have a final negative result according to the site-specific screening HIV testing algorithm and a final negative result at enrollment according to the study HIV testing algorithm\n6. Willing to participate in all aspects of the study and to comply with study procedures, for up to 60 weeks, including:\n\n * Be randomized\n * Use study product as directed\n * Adhere to follow-up schedule and willing to be contacted by site staff between study visits (by phone and/or in person)\n * Use a study-approved effective non-barrier method of contraception for the duration of the study\n * Take study product, as evidenced by swallowing a vitamin tablet that is similar in size to the study product at enrollment\n * Provide contact information and agrees to some form of contact method throughout the study\n7. Not intending to relocate out of the area for the duration of the study participation and does not have a job or other obligations that may require long absences from the area ( \\> 1 month at a time)\n8. In general good health and have no condition (social or medical) which, in the opinion of the Site Investigator, would make study participation unsafe or complicate data interpretation\n9. Not pregnant or breastfeeding, and does not anticipate a desire for pregnancy during the 52 weeks of on-product participation\n10. Medically eligible at screening including:\n\n * Adequate renal function (serum creatinine ≤ upper limit of normal (ULN) of local range and creatinine clearance ≥ 60ml/min estimated by the Cockcroft-Gault Creatinine Clearance Formula\n * Adequate hepatic function (hepatic transaminases ALT and AST \\< 2x ULN \\[according to local normal ranges\\])\n * HBsAg negative\n * Serum phosphorus levels above the lower limit of the local normal range (according to local normal ranges - grade 3 \\& 4 hypophosphatemia will be excluded even if within normal local ranges)\n11. Not received or receiving an experimental HIV vaccine, participating in another HIV prevention study or participating in any other clinical trial with a biomedical intervention\n12. No clinical signs of liver disease (e.g., ascites, spider angiomata, hepatomegaly, jaundice)\n13. No definite evidence of glycosuria or proteinuria (i.e., no repeated positive \\[ ≥ + 1 \\] urine dipstick). If a urine dipstick is positive for either glucose and/or protein at the first test, a second urine sample will be tested.\n14. No history of pathological bone fractures\n15. No history of adverse reaction to latex\n16. Not taking any of the following medications: nephrotoxic agents; aminoglycoside antibiotics (including gentamicin); intravenous (IV) amphotericin B; cidofovir; cisplatin; foscarnet; IV pentamidine; oral or IV vancomycin; oral or IV gancyclovir; other agents with significant nephrotoxic potential; drugs that slow renal excretion; probenecid; immune system modulators; systemic chemotherapeutic agents (i.e. cancer treatment medications); systemic corticosteroids; interleukin-2 (IL-2); immunomodulators; interferon (alpha, beta, or gamma); other antiretrovirals (including nucleoside analogs, non-nucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents)'}, 'identificationModule': {'nctId': 'NCT00625404', 'briefTitle': 'FEM-PrEP (Truvada®): Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women', 'organization': {'class': 'OTHER', 'fullName': 'FHI 360'}, 'officialTitle': 'Phase 3, Multi-center, Double-blind, Randomized, Placebo-controlled Effectiveness and Safety Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women', 'orgStudyIdInfo': {'id': '10015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Truvada Arm', 'description': 'Daily single oral tablet of Truvada (TDF/FTC), a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).', 'interventionNames': ['Drug: Truvada']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Arm', 'description': 'Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Truvada', 'type': 'DRUG', 'otherNames': ['TDF/FTC - emtricitabine and tenofovir disoproxil fumarate'], 'description': 'Daily single oral tablet of Truvada - a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).', 'armGroupLabels': ['Truvada Arm']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.', 'armGroupLabels': ['Placebo Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bondo', 'state': 'Nyanza', 'country': 'Kenya', 'facility': 'Bondo Clinic, Bondo District Hospital', 'geoPoint': {'lat': -0.0962, 'lon': 34.27322}}, {'city': 'Pretoria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Setshaba Research Centre', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'city': 'Bloemfontein', 'country': 'South Africa', 'facility': 'Josha Research Center', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'city': 'Arusha', 'country': 'Tanzania', 'facility': 'Arusha Clinic, Levolosi Health Center', 'geoPoint': {'lat': -3.36667, 'lon': 36.68333}}], 'overallOfficials': [{'name': 'Lut Van Damme, MD, MS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FHI 360'}, {'name': 'Amy Corneli, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FHI 360'}, {'name': 'Jennifer Deese, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'FHI 360'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FHI 360', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}