Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-02-23 @ 6:24 AM
Study NCT ID:
NCT00528957
Status:
COMPLETED
Last Update Posted:
2018-03-14
First Post:
2007-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D015215', 'term': 'Zidovudine'}, {'id': 'D018119', 'term': 'Stavudine'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013936', 'term': 'Thymidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GileadClinicalTrials@gilead.com', 'title': 'Clinical Trial Disclosures & Transparency', 'organization': 'Gilead Sciences'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were reported in the open-label randomized period (Weeks 0-48), and during the extension period when all participants received tenofovir DF.', 'description': 'Tenofovir DF and Stavudine or Zidovudine groups: AEs were reported from baseline through last dose (up to Week 48) + 30 days. AEs with onset during the extension period were excluded.\n\nAll TDF group: AEs were reported from baseline through last dose + 30 days (median duration of exposure = 330.7 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks)', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 37, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Stavudine or Zidovudine', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 35, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases', 'otherNumAtRisk': 89, 'deathsNumAtRisk': 89, 'otherNumAffected': 82, 'seriousNumAtRisk': 89, 'deathsNumAffected': 0, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acarodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lice infestation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Tinea versicolour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 57}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Asthmatic crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Amoebiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lymph node abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Shigella infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Snake bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Haemarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Asthmatic crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks)'}, {'id': 'OG001', 'title': 'Stavudine or Zidovudine', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '69.8', 'upperLimit': '92.5'}, {'value': '91.8', 'groupId': 'OG001', 'lowerLimit': '80.4', 'upperLimit': '97.7'}, {'value': '85.4', 'groupId': 'OG002', 'lowerLimit': '76.3', 'upperLimit': '92.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages between groups', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.5', 'ciLowerLimit': '-21.5', 'ciUpperLimit': '4.5', 'estimateComment': 'Difference is for tenofovir DF minus stavudine or zidovudine (randomized phase)', 'groupDescription': 'The statistical hypotheses for the primary endpoint was as follows:\n\n* Null Hypothesis: tenofovir DF group is more than 15% worse than the stavudine or zidovudine group with respect to the proportion of participants maintaining HIV-1 RNA concentrations \\< 400 copies/mL at Week 48.\n* Alternate Hypothesis: tenofovir DF group is no more than 15% worse than the stavudine or zidovudine group with respect to the proportion of participants maintaining HIV-1 RNA \\< 400 copies/mL at Week 48.', 'statisticalMethod': 'Normal approximation', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The difference between the two proportions and its CI were based on normal approximation methods.', 'nonInferiorityComment': 'In the randomized phase, it was assumed that the respective proportions of participants maintaining HIV-1 RNA \\< 400 copies/mL was 92% for participants switching to tenofovir DF and 90% for participants continuing stavudine or zidovudine, as estimated from previous GSI studies. The equivalence limit was set at -15% for the lower boundary of a two-sided 95% confidence interval (CI) on the difference in proportions of participants maintaining HIV-1 RNA \\< 400 copies/mL at Week 48.'}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 400 copies/mL after 48 weeks of exposure to randomized study drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Failure'}, {'type': 'SECONDARY', 'title': 'Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks)'}, {'id': 'OG001', 'title': 'Stavudine or Zidovudine', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '88.6', 'groupId': 'OG000'}, {'value': '89.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages between groups', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-13.7', 'ciUpperLimit': '11.8', 'estimateComment': 'The difference between the two proportions and its CI were based on normal approximation methods.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'In the randomized phase, it was assumed that the respective proportions of participants maintaining HIV-1 RNA \\< 400 copies/mL was 92% for subjects switching to tenofovir DF and 90% for subjects continuing stavudine or zidovudine, as estimated from previous GSI studies. The equivalence limit was set at -15% for the lower boundary of a two-sided 95% confidence interval (CI) on the difference in proportions of participants maintaining HIV-1 RNA \\< 400 copies/mL at Week 48.'}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'description': "This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug. The percentage of participants achieving HIV-1 RNA \\< 400 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) Analysis Set; only includes participants \\< 12 years of age at baseline'}, {'type': 'SECONDARY', 'title': 'Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 Copies/mL, Snapshot)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks)'}, {'id': 'OG001', 'title': 'Stavudine or Zidovudine', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '81.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'description': "This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug. The percentage of participants achieving HIV-1 RNA \\< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) Analysis Set; only includes participants \\< 12 years of age at baseline'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '81.6', 'groupId': 'OG000'}, {'value': '85.4', 'groupId': 'OG001'}, {'value': '83.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '96 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 400 copies/mL after 96 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases (All TDF group)'}], 'classes': [{'categories': [{'measurements': [{'value': '73.7', 'groupId': 'OG000'}, {'value': '87.5', 'groupId': 'OG001'}, {'value': '80.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '144 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 400 copies/mL after 144 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received TDF in the randomized and/or extension phases (All TDF group)'}], 'classes': [{'categories': [{'measurements': [{'value': '70.6', 'groupId': 'OG000'}, {'value': '82.5', 'groupId': 'OG001'}, {'value': '77.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '192 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 400 copies/mL after 192 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received TDF in the randomized and/or extension phases (All TDF group)'}], 'classes': [{'categories': [{'measurements': [{'value': '70.6', 'groupId': 'OG000'}, {'value': '75.7', 'groupId': 'OG001'}, {'value': '73.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '240 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 400 copies/mL after 240 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received TDF in the randomized and/or extension phases (All TDF group)'}], 'classes': [{'categories': [{'measurements': [{'value': '81.5', 'groupId': 'OG000'}, {'value': '67.6', 'groupId': 'OG001'}, {'value': '73.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '288 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 400 copies/mL after 288 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received TDF in the randomized and/or extension phases (All TDF group)'}], 'classes': [{'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '95.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '336 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 400 copies/mL after 336 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 384 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received TDF in the randomized and/or extension phases (All TDF group)'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '384 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 400 copies/mL after 384 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received TDF in the randomized and/or extension phases (All TDF group)'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '85.7', 'groupId': 'OG001'}, {'value': '95.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '432 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 400 copies/mL after 432 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received TDF in the randomized and/or extension phases (All TDF group)'}], 'classes': [{'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '90.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '480 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 400 copies/mL after 480 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 528 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received TDF in the randomized and/or extension phases (All TDF group)'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '528 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 400 copies/mL after 528 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks)'}, {'id': 'OG001', 'title': 'Stavudine or Zidovudine', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '70.8', 'groupId': 'OG000'}, {'value': '85.7', 'groupId': 'OG001'}, {'value': '68.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 50 copies/mL after 48 weeks of exposure to randomized study drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '76.3', 'groupId': 'OG000'}, {'value': '68.3', 'groupId': 'OG001'}, {'value': '72.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '96 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 50 copies/mL after 96 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}, {'value': '69.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '144 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 50 copies/mL after 144 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '67.6', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}, {'value': '71.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '192 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 50 copies/mL after 192 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '70.6', 'groupId': 'OG000'}, {'value': '73.0', 'groupId': 'OG001'}, {'value': '71.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '240 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 50 copies/mL after 240 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '81.5', 'groupId': 'OG000'}, {'value': '62.2', 'groupId': 'OG001'}, {'value': '70.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '288 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 50 copies/mL after 288 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '86.4', 'groupId': 'OG000'}, {'value': '90.5', 'groupId': 'OG001'}, {'value': '88.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '336 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 50 copies/mL after 336 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '88.2', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '92.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '384 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 50 copies/mL after 384 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}, {'value': '90.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '432 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 50 copies/mL after 432 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '72.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '480 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 50 copies/mL after 480 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 528 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '528 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 50 copies/mL after 528 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Percentage at 48 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks).'}, {'id': 'OG001', 'title': 'Stavudine or Zidovudine', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '4.49', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '4.73', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '3.85', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 48 weeks', 'description': 'This is the change from baseline in CD4 percentage after 48 weeks of exposure to randomized study drug.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Percentage at 96 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '4.08', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '3.60', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '3.88', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 96 weeks', 'description': 'This is the change from baseline in CD4 percentage after 96 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Percentage at 144 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '5.61', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '3.83', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '4.73', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 144 weeks', 'description': 'This is the change from baseline in CD4 percentage after 144 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Percentage at 192 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '5.57', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '3.69', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '4.58', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 192 weeks', 'description': 'This is the change from baseline in CD4 percentage after 192 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Percentage at 240 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '5.98', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '4.13', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '5.16', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 240 weeks', 'description': 'This is the change from baseline in CD4 percentage after 240 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Percentage at 288 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '6.30', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '4.77', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '5.58', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 288 weeks', 'description': 'This is the change from baseline in CD4 percentage after 288 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Percentage at 336 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '7.19', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '4.01', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '5.82', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 336 weeks', 'description': 'This is the change from baseline in CD4 percentage after 336 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Percentage at 384 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '7.80', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.90', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '6.37', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 384 weeks', 'description': 'This is the change from baseline in CD4 percentage after 384 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Percentage at 432 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '6.41', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '3.53', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '5.66', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 432 weeks', 'description': 'This is the change from baseline in CD4 percentage after 432 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Percentage at 480 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '7.15', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '10.00', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '7.51', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 480 weeks', 'description': 'This is the change from baseline in CD4 percentage after 480 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Percentage at 528 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '3.89', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '3.89', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 528 weeks', 'description': 'This is the change from baseline in CD4 percentage after 528 weeks of exposure to TDF.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks).'}, {'id': 'OG001', 'title': 'Stavudine or Zidovudine', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '-97', 'spread': '416.4', 'groupId': 'OG000'}, {'value': '-11', 'spread': '280.2', 'groupId': 'OG001'}, {'value': '2', 'spread': '385.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 48 weeks', 'description': 'This is the change from baseline in CD4 cell count after 48 weeks of exposure to randomized study drug.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '-77', 'spread': '408.3', 'groupId': 'OG000'}, {'value': '-56', 'spread': '305.6', 'groupId': 'OG001'}, {'value': '-67', 'spread': '358.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 96 weeks', 'description': 'This is the change from baseline in CD4 cell count after 96 weeks of exposure to TDF.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '-139', 'spread': '438.2', 'groupId': 'OG000'}, {'value': '-146', 'spread': '245.3', 'groupId': 'OG001'}, {'value': '-142', 'spread': '345.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 144 weeks', 'description': 'This is the change from baseline in CD4 cell count after 144 weeks of exposure to TDF.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '-304', 'spread': '529.0', 'groupId': 'OG000'}, {'value': '-177', 'spread': '288.5', 'groupId': 'OG001'}, {'value': '-233', 'spread': '413.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 192 weeks', 'description': 'This is the change from baseline in CD4 cell count after 192 weeks of exposure to TDF.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '-369', 'spread': '529.9', 'groupId': 'OG000'}, {'value': '-296', 'spread': '252.6', 'groupId': 'OG001'}, {'value': '-329', 'spread': '401.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 240 weeks', 'description': 'This is the change from baseline in CD4 cell count after 240 weeks of exposure to TDF.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '-346', 'spread': '507.5', 'groupId': 'OG000'}, {'value': '-256', 'spread': '292.5', 'groupId': 'OG001'}, {'value': '-302', 'spread': '414.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 288 weeks', 'description': 'This is the change from baseline in CD4 cell count after 288 weeks of exposure to TDF.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '-415', 'spread': '569.4', 'groupId': 'OG000'}, {'value': '-283', 'spread': '252.2', 'groupId': 'OG001'}, {'value': '-350', 'spread': '443.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 336 weeks', 'description': 'This is the change from baseline in CD4 cell count after 336 weeks of exposure to TDF.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Cell Count (Cells/mm^3) at 384 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '-620', 'spread': '635.6', 'groupId': 'OG000'}, {'value': '-305', 'spread': '238.2', 'groupId': 'OG001'}, {'value': '-512', 'spread': '548.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 384 weeks', 'description': 'This is the change from baseline in CD4 cell count after 384 weeks of exposure to TDF.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Cell Count (Cells/mm^3) at 432 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '-795', 'spread': '559.2', 'groupId': 'OG000'}, {'value': '-302', 'spread': '355.2', 'groupId': 'OG001'}, {'value': '-631', 'spread': '545.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 432 weeks', 'description': 'This is the change from baseline in CD4 cell count after 432 weeks of exposure to TDF.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Cell Count (Cells/mm^3) at 480 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '-923', 'spread': '755.4', 'groupId': 'OG000'}, {'value': '-448', 'spread': '469.9', 'groupId': 'OG001'}, {'value': '-813', 'spread': '712.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 480 weeks', 'description': 'This is the change from baseline in CD4 cell count after 480 weeks of exposure to TDF.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Cell Count (Cells/mm^3) at 528 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'OG001', 'title': '(Stavudine or Zidovudine)/TDF', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'OG002', 'title': 'All TDF', 'description': 'All participants who received tenofovir DF in the randomized and/or extension phases'}], 'classes': [{'categories': [{'measurements': [{'value': '-710', 'spread': '447.0', 'groupId': 'OG000'}, {'value': '-710', 'spread': '447.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 528 weeks', 'description': 'This is the change from baseline in CD4 cell count after 528 weeks of exposure to TDF.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, Missing = Excluded'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received tenofovir disoproxil fumarate (TDF) during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'FG001', 'title': 'Stavudine or Zidovudine', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}], 'periods': [{'title': 'Randomized Phase (Baseline to Week 48)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Safety, Tolerability, or Efficacy Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'First Extension (Week 48 to Week 144)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Six participants completed the 48-week randomized phase and did not enroll in the first extension.', 'groupId': 'FG000', 'numSubjects': '38'}, {'comment': 'Seven participants completed the 48-week randomized phase and did not enroll in the first extension.', 'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': "Investigator's Discretion", 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Safety, Tolerability, or Efficacy Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Second Extension (Week 144 to Week 240)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'One participant completed the first extension and did not enroll in the second extension.', 'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Safety, Tolerability, or Efficacy Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': "Investigator's Discretion", 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Third Extension (Week 240 to Week 336)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Safety, Tolerability, or Efficacy Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': '= 18 yr old & TDF approved in adults', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': "Investigator's Discretion", 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Long-Term Extension (Week 336 and On)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Two participants completed the third extension and did not enroll in the long-term extension.', 'groupId': 'FG000', 'numSubjects': '19'}, {'comment': 'Two participants completed the third extension and did not enroll in the long-term extension.', 'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Rolled Over to Study GS-US-311-1269', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Safety, Tolerability, or Efficacy Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': "Investigator's Discretion", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in the United States, Panama, and the United Kingdom. The first participant was screened on 28 December 2006. The last study visit occurred on 16 August 2017.', 'preAssignmentDetails': '127 participants were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tenofovir DF', 'description': 'Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).'}, {'id': 'BG001', 'title': 'Stavudine or Zidovudine', 'description': 'Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7', 'spread': '3.3', 'groupId': 'BG000'}, {'value': '7', 'spread': '2.6', 'groupId': 'BG001'}, {'value': '7', 'spread': '3.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Mestizo', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'Native Indian (Kuna)', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Panama', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '118', 'spread': '19.8', 'groupId': 'BG000'}, {'value': '119', 'spread': '16.7', 'groupId': 'BG001'}, {'value': '119', 'spread': '18.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '17.59', 'spread': '3.680', 'groupId': 'BG000'}, {'value': '16.59', 'spread': '1.762', 'groupId': 'BG001'}, {'value': '17.08', 'spread': '2.905', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '25.9', 'spread': '12.03', 'groupId': 'BG000'}, {'value': '24.1', 'spread': '7.77', 'groupId': 'BG001'}, {'value': '25.0', 'spread': '10.09', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Plasma HIV-1 RNA', 'classes': [{'categories': [{'title': '< 50 copies/mL', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': '50 to < 400 copies/mL', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': '400 to < 1000 copies/mL', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '≥ 1000 copies/mL', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'CD4 Cell Count', 'classes': [{'categories': [{'measurements': [{'value': '1190', 'spread': '541.7', 'groupId': 'BG000'}, {'value': '1144', 'spread': '388.4', 'groupId': 'BG001'}, {'value': '1167', 'spread': '468.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CD4 Percentage', 'classes': [{'categories': [{'measurements': [{'value': '33.9', 'spread': '7.44', 'groupId': 'BG000'}, {'value': '33.0', 'spread': '6.82', 'groupId': 'BG001'}, {'value': '33.5', 'spread': '7.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Randomized and Treated Set: participants who were randomized and received at least 1 dose of study drug'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'dispFirstSubmitDate': '2011-06-08', 'completionDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-14', 'studyFirstSubmitDate': '2007-01-03', 'dispFirstSubmitQcDate': '2011-06-08', 'resultsFirstSubmitDate': '2012-02-15', 'studyFirstSubmitQcDate': '2007-09-10', 'dispFirstPostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-02-15', 'studyFirstPostDateStruct': {'date': '2007-09-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48', 'timeFrame': '48 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 400 copies/mL after 48 weeks of exposure to randomized study drug.'}], 'secondaryOutcomes': [{'measure': 'Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot)', 'timeFrame': '48 weeks', 'description': "This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug. The percentage of participants achieving HIV-1 RNA \\< 400 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status."}, {'measure': 'Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 Copies/mL, Snapshot)', 'timeFrame': '48 weeks', 'description': "This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug. The percentage of participants achieving HIV-1 RNA \\< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status."}, {'measure': 'Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96', 'timeFrame': '96 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 400 copies/mL after 96 weeks of exposure to TDF.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144', 'timeFrame': '144 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 400 copies/mL after 144 weeks of exposure to TDF.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks', 'timeFrame': '192 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 400 copies/mL after 192 weeks of exposure to TDF.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks', 'timeFrame': '240 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 400 copies/mL after 240 weeks of exposure to TDF.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks', 'timeFrame': '288 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 400 copies/mL after 288 weeks of exposure to TDF.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks', 'timeFrame': '336 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 400 copies/mL after 336 weeks of exposure to TDF.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 384 Weeks', 'timeFrame': '384 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 400 copies/mL after 384 weeks of exposure to TDF.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks', 'timeFrame': '432 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 400 copies/mL after 432 weeks of exposure to TDF.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks', 'timeFrame': '480 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 400 copies/mL after 480 weeks of exposure to TDF.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 528 Weeks', 'timeFrame': '528 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 400 copies/mL after 528 weeks of exposure to TDF.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks', 'timeFrame': '48 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 50 copies/mL after 48 weeks of exposure to randomized study drug.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks', 'timeFrame': '96 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 50 copies/mL after 96 weeks of exposure to TDF.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks', 'timeFrame': '144 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 50 copies/mL after 144 weeks of exposure to TDF.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks', 'timeFrame': '192 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 50 copies/mL after 192 weeks of exposure to TDF.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks', 'timeFrame': '240 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 50 copies/mL after 240 weeks of exposure to TDF.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks', 'timeFrame': '288 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 50 copies/mL after 288 weeks of exposure to TDF.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks', 'timeFrame': '336 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 50 copies/mL after 336 weeks of exposure to TDF.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks', 'timeFrame': '384 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 50 copies/mL after 384 weeks of exposure to TDF.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks', 'timeFrame': '432 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 50 copies/mL after 432 weeks of exposure to TDF.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks', 'timeFrame': '480 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 50 copies/mL after 480 weeks of exposure to TDF.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 528 Weeks', 'timeFrame': '528 weeks', 'description': 'This is the percentage of participants with HIV-1 RNA \\< 50 copies/mL after 528 weeks of exposure to TDF.'}, {'measure': 'Change From Baseline in CD4 Percentage at 48 Weeks', 'timeFrame': 'Baseline and 48 weeks', 'description': 'This is the change from baseline in CD4 percentage after 48 weeks of exposure to randomized study drug.'}, {'measure': 'Change From Baseline in CD4 Percentage at 96 Weeks', 'timeFrame': 'Baseline and 96 weeks', 'description': 'This is the change from baseline in CD4 percentage after 96 weeks of exposure to TDF.'}, {'measure': 'Change From Baseline in CD4 Percentage at 144 Weeks', 'timeFrame': 'Baseline and 144 weeks', 'description': 'This is the change from baseline in CD4 percentage after 144 weeks of exposure to TDF.'}, {'measure': 'Change From Baseline in CD4 Percentage at 192 Weeks', 'timeFrame': 'Baseline and 192 weeks', 'description': 'This is the change from baseline in CD4 percentage after 192 weeks of exposure to TDF.'}, {'measure': 'Change From Baseline in CD4 Percentage at 240 Weeks', 'timeFrame': 'Baseline and 240 weeks', 'description': 'This is the change from baseline in CD4 percentage after 240 weeks of exposure to TDF.'}, {'measure': 'Change From Baseline in CD4 Percentage at 288 Weeks', 'timeFrame': 'Baseline and 288 weeks', 'description': 'This is the change from baseline in CD4 percentage after 288 weeks of exposure to TDF.'}, {'measure': 'Change From Baseline in CD4 Percentage at 336 Weeks', 'timeFrame': 'Baseline and 336 weeks', 'description': 'This is the change from baseline in CD4 percentage after 336 weeks of exposure to TDF.'}, {'measure': 'Change From Baseline in CD4 Percentage at 384 Weeks', 'timeFrame': 'Baseline and 384 weeks', 'description': 'This is the change from baseline in CD4 percentage after 384 weeks of exposure to TDF.'}, {'measure': 'Change From Baseline in CD4 Percentage at 432 Weeks', 'timeFrame': 'Baseline and 432 weeks', 'description': 'This is the change from baseline in CD4 percentage after 432 weeks of exposure to TDF.'}, {'measure': 'Change From Baseline in CD4 Percentage at 480 Weeks', 'timeFrame': 'Baseline and 480 weeks', 'description': 'This is the change from baseline in CD4 percentage after 480 weeks of exposure to TDF.'}, {'measure': 'Change From Baseline in CD4 Percentage at 528 Weeks', 'timeFrame': 'Baseline and 528 weeks', 'description': 'This is the change from baseline in CD4 percentage after 528 weeks of exposure to TDF.'}, {'measure': 'Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks', 'timeFrame': 'Baseline and 48 weeks', 'description': 'This is the change from baseline in CD4 cell count after 48 weeks of exposure to randomized study drug.'}, {'measure': 'Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks', 'timeFrame': 'Baseline and 96 weeks', 'description': 'This is the change from baseline in CD4 cell count after 96 weeks of exposure to TDF.'}, {'measure': 'Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks', 'timeFrame': 'Baseline and 144 weeks', 'description': 'This is the change from baseline in CD4 cell count after 144 weeks of exposure to TDF.'}, {'measure': 'Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks', 'timeFrame': 'Baseline and 192 weeks', 'description': 'This is the change from baseline in CD4 cell count after 192 weeks of exposure to TDF.'}, {'measure': 'Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks', 'timeFrame': 'Baseline and 240 weeks', 'description': 'This is the change from baseline in CD4 cell count after 240 weeks of exposure to TDF.'}, {'measure': 'Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks', 'timeFrame': 'Baseline and 288 weeks', 'description': 'This is the change from baseline in CD4 cell count after 288 weeks of exposure to TDF.'}, {'measure': 'Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks', 'timeFrame': 'Baseline and 336 weeks', 'description': 'This is the change from baseline in CD4 cell count after 336 weeks of exposure to TDF.'}, {'measure': 'Change From Baseline in CD4 Cell Count (Cells/mm^3) at 384 Weeks', 'timeFrame': 'Baseline and 384 weeks', 'description': 'This is the change from baseline in CD4 cell count after 384 weeks of exposure to TDF.'}, {'measure': 'Change From Baseline in CD4 Cell Count (Cells/mm^3) at 432 Weeks', 'timeFrame': 'Baseline and 432 weeks', 'description': 'This is the change from baseline in CD4 cell count after 432 weeks of exposure to TDF.'}, {'measure': 'Change From Baseline in CD4 Cell Count (Cells/mm^3) at 480 Weeks', 'timeFrame': 'Baseline and 480 weeks', 'description': 'This is the change from baseline in CD4 cell count after 480 weeks of exposure to TDF.'}, {'measure': 'Change From Baseline in CD4 Cell Count (Cells/mm^3) at 528 Weeks', 'timeFrame': 'Baseline and 528 weeks', 'description': 'This is the change from baseline in CD4 cell count after 528 weeks of exposure to TDF.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Phase 3', 'Randomized, Open-Label', 'Treatment-Experienced', 'Highly Active Antiretroviral Therapy', 'HIV', 'Tenofovir DF', 'Pediatrics'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '25760565', 'type': 'DERIVED', 'citation': 'Saez-Llorens X, Castano E, Rathore M, Church J, Deville J, Gaur A, Estripeaut D, White K, Arterburn S, Enejosa JV, Cheng AK, Chuck SL, Rhee MS. A randomized, open-label study of the safety and efficacy of switching stavudine or zidovudine to tenofovir disoproxil fumarate in HIV-1-infected children with virologic suppression. Pediatr Infect Dis J. 2015 Apr;34(4):376-82. doi: 10.1097/INF.0000000000000289.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess the efficacy of switching to tenofovir disoproxil fumarate (TDF) compared to continuing stavudine or zidovudine in maintaining virologic suppression in HIV-1 infected children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Major Inclusion Criteria:\n\n* Documented laboratory diagnosis of HIV-1 infection\n* Plasma HIV-1 RNA \\< 400 copies/mL\n* Currently on a stable stavudine or zidovudine -containing antiretroviral therapy regimen for at least 12 weeks\n* Naive to tenofovir DF\n\nKey Inclusion Criteria for the First 96-Week Extension\n\n* Completed 48 weeks of treatment in Arm 1 or Arm 2 of the study\n* \\<18 years of age (at the start of the extension)\n* Participants initially randomized to Arm 2 will be given the option to replace stavudine or zidovudine with tenofovir DF in the 96-week extension at the investigator's discretion, if the investigator determines that tenofovir DF is safe and beneficial for the participant.\n\nKey Inclusion Criteria for the Second and Third 96-Week Extension and Fourth Open-Ended Extension\n\n* Completed of treatment with study drug in the first extension phase\n* \\<18 years of age at the start of the extension. This inclusion criterion is not applicable in those regions where tenofovir DF is not commercially available for treatment of HIV-1 infection in adults.\n\nKey Exclusion Criteria:\n\n* Participants receiving ongoing therapy with any of the following\n* Nephrotoxic agents\n* Systemic chemotherapeutic agents\n* Systemic corticosteroids\n* Interleukin 2 (IL 2) and other immunomodulating agents\n* Investigational agents\n* Pregnant or lactating participants\n* Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication\n* Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance\n* Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma.\n* Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic therapy within 15 days prior to screening\n* Prior history of significant renal disease (ie, nephrotic syndrome, renal dysgenesis, polycystic kidney disease, congenital nephrosis)\n* Prior history of significant bone disease (ie, osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochondroses, multiple bone fractures)\n\nNote: Other protocol defined Inclusion/ Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT00528957', 'briefTitle': 'Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase III, Randomized, Open-Label Study Comparing the Safety and Efficacy of Switching Stavudine or Zidovudine to Tenofovir Disoproxil Fumarate Versus Continuing Stavudine or Zidovudine in Virologically Suppressed HIV-Infected Children Taking Highly Active Antiretroviral Therapy', 'orgStudyIdInfo': {'id': 'GS-US-104-0352'}, 'secondaryIdInfos': [{'id': '2007-003418-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tenofovir DF', 'interventionNames': ['Drug: Tenofovir DF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'stavudine or zidovudine', 'interventionNames': ['Drug: Zidovudine', 'Drug: Stavudine']}], 'interventions': [{'name': 'Tenofovir DF', 'type': 'DRUG', 'otherNames': ['Viread®'], 'description': 'Tenofovir DF (oral powder or tablet): 300-mg tablets for participants \\> 37 kg; 8-mg/kg oral powder (up to 300 mg) for participants ≤ 37 kg. During the extension phase, participants whose weight increases to \\> 37 kg may be switched from the oral powder to the tenofovir DF tablet.', 'armGroupLabels': ['Tenofovir DF']}, {'name': 'Zidovudine', 'type': 'DRUG', 'description': 'Zidovudine as prescribed by the investigator prior to study entry (pediatric participants \\< 30 kg: 1 mg/kg/dose given every 12 hours; pediatric participants ≥ 30 kg: 30 mg twice daily).', 'armGroupLabels': ['stavudine or zidovudine']}, {'name': 'Stavudine', 'type': 'DRUG', 'description': 'Stavudine as prescribed by the investigator prior to study entry (pediatric participants 6 weeks to 12 years of age: 160 mg/m\\^2 every 8 hours; pediatric participants \\> 12 years of age: 300 mg twice daily).', 'armGroupLabels': ['stavudine or zidovudine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jeffrey Goodman Special Care Clinic', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University California Los Angeles, School of Medicine, Pediatric, Infectious Diseases', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': "Children's Diagnostic and Treatment Center, Inc", 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida, Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '19134', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "St. Christopher's Hospital for Children", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'city': 'Panama City', 'country': 'Panama', 'facility': 'Hospital del Nino', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Great Ormond Street Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College London, Paediatrics Infectious Diseases', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}