Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT00608569
Status:
COMPLETED
Last Update Posted:
2018-10-12
First Post:
2008-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Determining the Effects of Observed and Self-Administered Drug Regimens in HIV Infected Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Panama']}, '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': 'D061466', 'term': 'Lopinavir'}, {'id': 'C558899', 'term': 'lopinavir-ritonavir drug combination'}, {'id': 'D000069480', 'term': 'Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}, {'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D015215', 'term': 'Zidovudine'}, {'id': 'D000068679', 'term': 'Emtricitabine'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013936', 'term': 'Thymidine'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ACTGCT.Gov@s-3.com', 'phone': '(301) 628-3313', 'title': 'ACTG ClinicalTrials.gov Coordinator', 'organization': 'ACTG Network Coordinating Center, Social and Scientific Systems, Inc.'}, 'certainAgreement': {'otherDetails': 'In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights".', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '52 weeks since randomization', 'description': 'Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and ≥grade 3 AEs (where grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).', 'eventGroups': [{'id': 'EG000', 'title': 'mDOT Arm', 'description': 'Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.', 'otherNumAtRisk': 129, 'otherNumAffected': 94, 'seriousNumAtRisk': 129, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Non-mDOT Arm', 'description': 'Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.', 'otherNumAtRisk': 128, 'otherNumAffected': 98, 'seriousNumAtRisk': 128, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blood bicarbonate abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blood cholesterol', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blood sodium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 48}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ruptured ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Confirmed Virologic Failure at or Prior to Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'mDOT Arm', 'description': 'Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.'}, {'id': 'OG001', 'title': 'Non-mDOT Arm', 'description': 'Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.'}], 'classes': [{'title': 'No Failure', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}, {'title': 'Experienced Failure', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.133', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Results were considered to be statistically significant if p\\<0.05', 'groupDescription': 'Fisher exact test (unstratified)', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'At or prior to Week 48', 'description': 'Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) \\<1 log10 copies/mL below the baseline level and \\>400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) \\>400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤50 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 48 was reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Two hundred fifty seven eligible participants were included in the analysis. Intent to treat analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Confirmed Virologic Failure at or Prior to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'mDOT Arm', 'description': 'Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.'}, {'id': 'OG001', 'title': 'Non-mDOT Arm', 'description': 'Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.'}], 'classes': [{'title': 'No Failure', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}, {'title': 'Experienced Failure', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At or prior to Week 24', 'description': 'Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) \\<1 log10 copies/mL below the baseline level and \\>400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) \\>400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤30 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 24 was reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Two hundred fifty seven eligible participants were included in the analysis. Intent to treat analysis was performed.'}, {'type': 'SECONDARY', 'title': 'CD4 Count at Follow-up Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'mDOT Arm', 'description': 'Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.'}, {'id': 'OG001', 'title': 'Non-mDOT Arm', 'description': 'Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '212', 'groupId': 'OG000', 'lowerLimit': '129', 'upperLimit': '309'}, {'value': '219', 'groupId': 'OG001', 'lowerLimit': '158', 'upperLimit': '289'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '225', 'groupId': 'OG000', 'lowerLimit': '168', 'upperLimit': '359'}, {'value': '235', 'groupId': 'OG001', 'lowerLimit': '174', 'upperLimit': '337'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '268', 'groupId': 'OG000', 'lowerLimit': '177', 'upperLimit': '382'}, {'value': '266', 'groupId': 'OG001', 'lowerLimit': '181', 'upperLimit': '395'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '281', 'groupId': 'OG000', 'lowerLimit': '189', 'upperLimit': '395'}, {'value': '294', 'groupId': 'OG001', 'lowerLimit': '214', 'upperLimit': '418'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '301', 'groupId': 'OG000', 'lowerLimit': '198', 'upperLimit': '432'}, {'value': '347', 'groupId': 'OG001', 'lowerLimit': '234', 'upperLimit': '466'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Weeks 4, 12, 24, 36, and 48', 'description': 'CD4 cell count (median, inter-quartile range)', 'unitOfMeasure': 'cells/mm3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CD8 Count at Follow-up Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'mDOT Arm', 'description': 'Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.'}, {'id': 'OG001', 'title': 'Non-mDOT Arm', 'description': 'Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '776', 'groupId': 'OG000', 'lowerLimit': '557', 'upperLimit': '1048'}, {'value': '859', 'groupId': 'OG001', 'lowerLimit': '557', 'upperLimit': '1141'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '895', 'groupId': 'OG000', 'lowerLimit': '625', 'upperLimit': '1155'}, {'value': '916', 'groupId': 'OG001', 'lowerLimit': '635', 'upperLimit': '1290'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '816', 'groupId': 'OG000', 'lowerLimit': '586', 'upperLimit': '1071'}, {'value': '818', 'groupId': 'OG001', 'lowerLimit': '547', 'upperLimit': '1126'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '787', 'groupId': 'OG000', 'lowerLimit': '539', 'upperLimit': '1034'}, {'value': '833', 'groupId': 'OG001', 'lowerLimit': '598', 'upperLimit': '1131'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '815', 'groupId': 'OG000', 'lowerLimit': '566', 'upperLimit': '1037'}, {'value': '823', 'groupId': 'OG001', 'lowerLimit': '573', 'upperLimit': '1125'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At week 4, 12, 24, 36, and 48', 'description': 'CD8 cell count (median, inter-quartile range)', 'unitOfMeasure': 'cells/mm3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to First Grade 3 or 4 Lab Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'mDOT Arm', 'description': 'Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.'}, {'id': 'OG001', 'title': 'Non-mDOT Arm', 'description': 'Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.'}], 'classes': [{'title': '5th percentile', 'categories': [{'measurements': [{'value': '24', 'comment': 'Not estimable as the upper limit for survival function at all weeks is above 95%', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable as the estimates for survival function at all weeks is above 95%', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': 'NA'}]}]}, {'title': '10th percentile', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable as the estimates for survival function at all weeks is above 90%', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable as the estimates for survival function at all weeks is above 90%', 'groupId': 'OG001', 'lowerLimit': '36.9', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks since randomization', 'description': '5th and 10th percentiles in weeks from randomization to first grade 3 or 4 lab event', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Two hundred fifty seven eligible participants were included in the analysis. As-treated analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Time to First Grade 3 or 4 Sign or Symptom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'mDOT Arm', 'description': 'Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.'}, {'id': 'OG001', 'title': 'Non-mDOT Arm', 'description': 'Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.'}], 'classes': [{'title': '5th percentile', 'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '48'}, {'value': '26.7', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '48.9'}]}]}, {'title': '10th percentile', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable as the estimates for survival function at all weeks is above 90%', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': 'NA'}, {'value': '48.9', 'comment': 'Not estimable as the upper limit for survival function at all weeks is above 90%', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks since randomization', 'description': '5th and 10th percentiles in weeks from randomization to first grade 3 or 4 sign or symptom', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Two hundred fifty seven eligible participants were included in the analysis. As-treated analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Time to First Grade 3 or 4 Lab or Sign/Symptom Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'mDOT Arm', 'description': 'Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.'}, {'id': 'OG001', 'title': 'Non-mDOT Arm', 'description': 'Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.'}], 'classes': [{'title': '5th percentile', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '13.7'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '32.1'}]}]}, {'title': '10th percentile', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '4.4', 'upperLimit': '48'}, {'value': '32.6', 'comment': 'Not estimable as the upper limit for survival function at all weeks is above 90%', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks since randomization', 'description': '5th and 10th percentiles in weeks from randomization to first grade 3 or 4 lab or sign/ symptom event', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Two hundred fifty seven eligible participants were included in the analysis. As-treated analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Adherence to Second Line HAART Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'mDOT Arm', 'description': 'Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.'}, {'id': 'OG001', 'title': 'Non-mDOT Arm', 'description': 'Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At weeks 4, 8, 12, 24, 36, 48 and 52', 'description': 'Number of participants with self-reported 100% adherence over the week prior to study visit', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only the 257 eligible participants were included in the analysis. Self-reported adherence was collected face-to-face or by self-report on the Adherence/Quality of Life/Psychosocial Interview form. Only adherence to LPV/rtv was collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'mDOT Arm', 'description': 'Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.'}, {'id': 'FG001', 'title': 'Non-mDOT Arm', 'description': 'Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '128'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '119'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Unable to adhere with study requirements', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited across 9 study sites (2 in Peru, one each in South Africa, Haiti, Uganda, Botswana, Zimbabwe, Brazil and Zambia) in the AIDS Clinical Trials Group system between April 2009 and September 2011.', 'preAssignmentDetails': 'Five hundred twenty nine subjects including participants and partners entered the study. Among the 529 subjects, 259 were participants, which included two participants with eligibility violations. Only the 257 eligible participants were included in the analyses. All participants started TDF/FTC +LPV/rtv and stratified by screening HIV-1 RNA only.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'mDOT Arm', 'description': 'Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.'}, {'id': 'BG001', 'title': 'Non-mDOT Arm', 'description': 'Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.3', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '39.4', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '39.4', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black Non-Hispanic', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic (regardless of race)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Haiti', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}, {'title': 'Zambia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Botswana', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Peru', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Uganda', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Zimbabwe', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'CD4 Counts', 'classes': [{'categories': [{'measurements': [{'value': '164', 'groupId': 'BG000', 'lowerLimit': '91', 'upperLimit': '250'}, {'value': '201', 'groupId': 'BG001', 'lowerLimit': '97', 'upperLimit': '292'}, {'value': '179', 'groupId': 'BG002', 'lowerLimit': '92', 'upperLimit': '269'}]}]}], 'paramType': 'MEDIAN', 'description': 'The baseline CD4 count is the average of screening and entry values.', 'unitOfMeasure': 'cells/mm3', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'CD4 Count Category', 'classes': [{'title': '0-50 cells/mm3', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': '51-100 cells/mm3', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': '101-200 cells/mm3', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}, {'title': '201-350 cells/mm3', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}, {'title': '351-500 cells/mm3', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': '>500 cells/mm3', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Log10 HIV-1 RNA Viral Load', 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'groupId': 'BG000', 'lowerLimit': '3.8', 'upperLimit': '4.9'}, {'value': '4.3', 'groupId': 'BG001', 'lowerLimit': '3.8', 'upperLimit': '4.9'}, {'value': '4.3', 'groupId': 'BG002', 'lowerLimit': '3.8', 'upperLimit': '4.9'}]}]}], 'paramType': 'MEDIAN', 'description': 'The baseline HIV-1 RNA value is the result at study entry.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'HIV-1 RNA Viral Load Category', 'classes': [{'title': '<=400 copies/mL', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': '401-999 copies/mL', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': '1000-9999 copies/mL', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}, {'title': '10000-99999 copies/mL', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}, {'title': '100000-499999 copies/mL', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': '>=500000 copies/mL', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Five hundred twenty nine subjects including participants and partners entered the study. Among the 529 subjects, 259 were participants, which include two participants with eligibility violations. Only the 257 eligible participants were included in the analysis.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 529}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-11', 'studyFirstSubmitDate': '2008-01-21', 'resultsFirstSubmitDate': '2013-09-05', 'studyFirstSubmitQcDate': '2008-01-23', 'lastUpdatePostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-11-14', 'studyFirstPostDateStruct': {'date': '2008-02-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Confirmed Virologic Failure at or Prior to Week 48', 'timeFrame': 'At or prior to Week 48', 'description': 'Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) \\<1 log10 copies/mL below the baseline level and \\>400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) \\>400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤50 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 48 was reported.'}], 'secondaryOutcomes': [{'measure': 'Confirmed Virologic Failure at or Prior to Week 24', 'timeFrame': 'At or prior to Week 24', 'description': 'Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) \\<1 log10 copies/mL below the baseline level and \\>400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) \\>400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤30 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 24 was reported.'}, {'measure': 'CD4 Count at Follow-up Visits', 'timeFrame': 'At Weeks 4, 12, 24, 36, and 48', 'description': 'CD4 cell count (median, inter-quartile range)'}, {'measure': 'CD8 Count at Follow-up Visits', 'timeFrame': 'At week 4, 12, 24, 36, and 48', 'description': 'CD8 cell count (median, inter-quartile range)'}, {'measure': 'Time to First Grade 3 or 4 Lab Event', 'timeFrame': '52 weeks since randomization', 'description': '5th and 10th percentiles in weeks from randomization to first grade 3 or 4 lab event'}, {'measure': 'Time to First Grade 3 or 4 Sign or Symptom', 'timeFrame': '52 weeks since randomization', 'description': '5th and 10th percentiles in weeks from randomization to first grade 3 or 4 sign or symptom'}, {'measure': 'Time to First Grade 3 or 4 Lab or Sign/Symptom Event', 'timeFrame': '52 weeks since randomization', 'description': '5th and 10th percentiles in weeks from randomization to first grade 3 or 4 lab or sign/ symptom event'}, {'measure': 'Adherence to Second Line HAART Regimen', 'timeFrame': 'At weeks 4, 8, 12, 24, 36, 48 and 52', 'description': 'Number of participants with self-reported 100% adherence over the week prior to study visit'}]}, 'conditionsModule': {'keywords': ['Drug Therapy, Combination', 'HIV Non-Nucleoside Reverse Transcriptase Inhibitors', 'HIV Protease Inhibitors', 'Viral Load', 'Virologic Failure'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '17547827', 'type': 'BACKGROUND', 'citation': 'Bangsberg DR, Kroetz DL, Deeks SG. Adherence-resistance relationships to combination HIV antiretroviral therapy. Curr HIV/AIDS Rep. 2007 May;4(2):65-72. doi: 10.1007/s11904-007-0010-0.'}, {'pmid': '17525686', 'type': 'BACKGROUND', 'citation': 'Conway B. The role of adherence to antiretroviral therapy in the management of HIV infection. J Acquir Immune Defic Syndr. 2007 Jun 1;45 Suppl 1:S14-8. doi: 10.1097/QAI.0b013e3180600766.'}, {'pmid': '17639650', 'type': 'BACKGROUND', 'citation': 'Goggin K, Liston RJ, Mitty JA. Modified directly observed therapy for antiretroviral therapy: a primer from the field. Public Health Rep. 2007 Jul-Aug;122(4):472-81. doi: 10.1177/003335490712200408.'}, {'pmid': '17693890', 'type': 'BACKGROUND', 'citation': 'Pearson CR, Micek MA, Simoni JM, Hoff PD, Matediana E, Martin DP, Gloyd SS. Randomized control trial of peer-delivered, modified directly observed therapy for HAART in Mozambique. J Acquir Immune Defic Syndr. 2007 Oct 1;46(2):238-44. doi: 10.1097/QAI.0b013e318153f7ba.'}, {'pmid': '34788110', 'type': 'DERIVED', 'citation': 'Mantshonyane L, Roy J, Levy MZ, Wallis CL, Bar K, Godfrey C, Collier A, LaRosa A, Zheng L, Sun X, Gross R. Participants Switching to Second-Line Antiretroviral Therapy with Susceptible Virus Display Inferior Adherence and Worse Outcomes: An Observational Analysis. AIDS Patient Care STDS. 2021 Dec;35(12):467-473. doi: 10.1089/apc.2021.0115. Epub 2021 Nov 16.'}, {'pmid': '26774947', 'type': 'DERIVED', 'citation': 'De Boni RB, Zheng L, Rosenkranz SL, Sun X, Lavenberg J, Cardoso SW, Grinsztejn B, La Rosa A, Pierre S, Severe P, Cohn SE, Collier AC, Gross R. Binge drinking is associated with differences in weekday and weekend adherence in HIV-infected individuals. Drug Alcohol Depend. 2016 Feb 1;159:174-80. doi: 10.1016/j.drugalcdep.2015.12.013. Epub 2015 Dec 24.'}, {'pmid': '26424232', 'type': 'DERIVED', 'citation': 'Gross R, Zheng L, La Rosa A, Sun X, Rosenkranz SL, Cardoso SW, Ssali F, Camp R, Godfrey C, Cohn SE, Robbins GK, Chisada A, Wallis CL, Reynolds NR, Lu D, Safren SA, Hosey L, Severe P, Collier AC; ACTG 5234 team. Partner-based adherence intervention for second-line antiretroviral therapy (ACTG A5234): a multinational randomised trial. Lancet HIV. 2015 Jan;2(1):e12-9. doi: 10.1016/S2352-3018(14)00007-1. Epub 2014 Dec 11.'}]}, 'descriptionModule': {'briefSummary': 'Highly active antiretroviral therapy (HAART) has led to better health and survival rates among people with HIV/AIDS. The purpose of this study was to measure the effect of trained partner supervision when taking medication versus self-administered therapy in HIV infected participants. These participants have had their first virologic failure on a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based HAART regimen and were starting a protease inhibitor (PI)-based HAART regimen at study entry.', 'detailedDescription': 'Poor adherence to HAART is usually associated with resistant virus. Poor adherence to HAART can have serious consequences, including limited treatment options for HIV infected individuals if they become infected with resistant HIV. The purpose of this study was to examine the effectiveness of modified directly observed therapy (mDOT) and compare it with the effectiveness of self-administered therapy (non-mDOT) in HIV infected individuals with first virologic failure on an NNRTI-based HAART regimen who were starting a PI-based HAART regimen at study entry.\n\nmDOT was defined in this study as the daily observation of lopinavir/ritonavir (LPV/r) being taken on a regular basis. Observation consisted of an mDOT partner being present at the time the study participant took the observed dose. Half of the participants in this study were required to choose an mDOT partner to supervise adherence for the first 24 weeks of the study. Each mDOT partner completed the study-administered mDOT training program and was required to record all observed doses in an mDOT diary log. All participants and partners received health education through the study. Adherence was measured using Medication Event Monitoring System (MEMS) caps and self-report questionnaires.\n\nThis study lasted 52 weeks. Per protocol, participants were to be stratified according to their screening viral load and the proposed study treatment. The study treatment each participant received was based on their treatment history. At entry, participants were to start one of the two PI-based HAART regimens, either FTC/Tenofovir Disoproxil Fumarate (TDF) 200/300 mg once daily (QD) and Lopinavir/Ritonavir (LPV/RTV) 400/100 mg twice a day (BID) or TDF 300 mg QD and zidovudine (ZDV) 300 mg BID and LPV/RTV 400/100 mg BID. mDOT was used for the first 24 weeks of the study, followed by self-administration of study medications from week 25 to week 52. ZDV was not provided by the study. All enrolled participants except one who did not start study regimen initiated FTC/TDF and LPV/rtv after randomization. No participants started ZDV containing regimen on study. Thus, participants in this study were stratified by screening HIV-1 RNA only.\n\nThere were eight visits during the study. Medical and medication history, blood collection, and clinical assessment were required at all visits. A quality of life questionnaire and an adherence tools assessment were collected at most visits. For the mDOT arm, medication diary logs and mDOT partner monitoring were reviewed at most visits. An mDOT exit questionnaire and exit interview were required at the end of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria for Participants:\n\n* HIV infected\n* Have experienced or currently experiencing first baseline virologic failure on first NNRTI-based HAART regimen with no history of virologic failure on another regimen OR discontinued first NNRTI-based HAART regimen without the recommendations of clinicians and currently experiencing virologic failure with no history of virologic failure on another regimen. More information on this criterion can be found in the protocol.\n* Confirmed virologic failure within 45 days of study entry\n* Receiving one of the following NNRTI-based regimens for at least 16 weeks prior to study entry: ZDV+3TC+NVP, ZDV+3TC+EFV, d4T+3TC+NVP or d4T+3TC+EFV\n* Able to identify a close friend, relative, or spouse who is willing to serve as a partner\n* Intend to stay in current geographical area of residence for the duration of the study\n* Agree to use LPV/rtv with MEMS caps and take the tablets out of the container only at dosing\n* Willing to use acceptable forms of contraception\n* Ability and willingness of participant or legal guardian/representative to give written informed consent.\n* Required laboratory values obtained within 45 days prior to study entry.\n* Negative serum or urine pregnancy test obtained within 48 hours prior to study entry for women of reproductive potential.\n\nInclusion Criteria for Partners:\n\n* Not a participant\n* Friend, family member, or spouse who knows of the participant's HIV status. Partners do not have to live with participants.\n* Willing to attend a 1- to 2-hour taped training session prior to study entry\n* Willing to attend study visits with participant at study screening; entry; and Weeks 4, 8, 12, 24, and 52\n* Willing to directly observe participant taking at least one dose of LPV/rtv for at least 5 days per week for 24 weeks after stratification of participant\n* Willing to act as a positive support for participant\n* Willing to notify clinical staff of participant's nonadherence to study assigned regimen\n* Willing to notify clinical staff if they are unable to provide mDOT for 2 weeks or more\n* Willing to complete medication diary logs\n* Willing to complete exit interview\n* Agree to have their training session taped (if required).\n* For mDOT arm, willing to discuss and decide with participants whether to continue mDOT after Week 24\n* At least 18 years old\n* Understand that participants have agreed to use LPV/RTV with MEMS caps and take the tablets out of the container only at dosing\n* Ability and willingness to give written informed consent.\n* No intention to relocate away from current geographical area of residence for the duration of study participation.\n\nExclusion Criteria for Participants:\n\n* Use of any immunomodulator, HIV vaccine, or other investigational therapy within 45 days of study entry\n* Prior treatment with any PI\n* Previously diagnosed cancer other than basal cell carcinoma and cutaneous Kaposi's sarcoma\n* Use of rifampin or rifabutin within 45 days of study entry or plan use of rifampin or rifabutin\n* Requirement for taking any medications that are prohibited by this study. More information on this criterion can be found in the protocol.\n* Known allergy to the study medications or their formulations\n* Current drug or alcohol use that, in the opinion of the investigator, would interfere with the study\n* Acute illness requiring hospitalization within 14 days of study entry\n* Active tuberculosis (TB) infection\n* Currently incarcerated\n* Participation as a partner in this study\n* Participation with no access to telephones\n* Abnormal laboratory values\n* Pregnant, breastfeeding, or intend to become pregnant\n\nExclusion Criteria for Partners:\n\n* A participant in this study\n* Participation as a partner to any other participant\n* No access to telephones\n* Currently incarcerated"}, 'identificationModule': {'nctId': 'NCT00608569', 'briefTitle': 'Determining the Effects of Observed and Self-Administered Drug Regimens in HIV Infected Adults', 'organization': {'class': 'NETWORK', 'fullName': 'Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections'}, 'officialTitle': 'International Trial of Modified Directly Observed Therapy Versus Self-Administered Therapy for Participants With First Virologic Failure on a Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Antiretroviral Regimen', 'orgStudyIdInfo': {'id': 'ACTG A5234'}, 'secondaryIdInfos': [{'id': '1U01AI068636', 'link': 'https://reporter.nih.gov/quickSearch/1U01AI068636', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mDOT arm', 'description': 'Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.', 'interventionNames': ['Drug: Lopinavir/ritonavir', 'Drug: Emtricitabine/Tenofovir disoproxil fumarate', 'Drug: Tenofovir disoproxil fumarate', 'Drug: Zidovudine', 'Drug: Emtricitabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'non-mDOT arm', 'description': 'Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.', 'interventionNames': ['Drug: Lopinavir/ritonavir', 'Drug: Emtricitabine/Tenofovir disoproxil fumarate', 'Drug: Tenofovir disoproxil fumarate', 'Drug: Zidovudine', 'Drug: Emtricitabine']}], 'interventions': [{'name': 'Lopinavir/ritonavir', 'type': 'DRUG', 'otherNames': ['LPV/RTV', 'LPV/r', 'Kaletra'], 'description': 'Two tablets (200-mg lopinavir and 50 mg ritonavir in each tablet), taken orally twice daily', 'armGroupLabels': ['mDOT arm', 'non-mDOT arm']}, {'name': 'Emtricitabine/Tenofovir disoproxil fumarate', 'type': 'DRUG', 'otherNames': ['FTC/TDF', 'Truvada'], 'description': '200-mg emtricitabine and 300 mg tenofovir disoproxil fumarate in each tablet, taken orally once daily', 'armGroupLabels': ['mDOT arm', 'non-mDOT arm']}, {'name': 'Tenofovir disoproxil fumarate', 'type': 'DRUG', 'otherNames': ['TDF', 'Viread'], 'description': '300-mg tablet taken orally once daily', 'armGroupLabels': ['mDOT arm', 'non-mDOT arm']}, {'name': 'Zidovudine', 'type': 'DRUG', 'otherNames': ['ZDV', 'Retrovir'], 'description': '300-mg tablet taken orally twice daily', 'armGroupLabels': ['mDOT arm', 'non-mDOT arm']}, {'name': 'Emtricitabine', 'type': 'DRUG', 'otherNames': ['FTC', 'Emtriva'], 'description': '200-mg tablet taken orally once daily', 'armGroupLabels': ['mDOT arm', 'non-mDOT arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gaborone', 'country': 'Botswana', 'facility': 'Gaborone Prevention/Treatment Trials CRS', 'geoPoint': {'lat': -24.65451, 'lon': 25.90859}}, {'zip': '21045', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Instituto de Pesquisa Clinica Evandro Chagas (12101)', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': 'HT-6110', 'city': 'Bicentenaire', 'state': 'Port-au-Prince', 'country': 'Haiti', 'facility': 'Les Centres GHESKIO CRS'}, {'city': 'San Miguel', 'state': 'Lima region', 'country': 'Peru', 'facility': 'San Miguel CRS', 'geoPoint': {'lat': -11.45222, 'lon': -76.62528}}, {'zip': '18', 'city': 'Lima', 'country': 'Peru', 'facility': 'Barranco CRS', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Wits HIV CRS', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'Kampala', 'country': 'Uganda', 'facility': 'JCRC CRS', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}, {'city': 'Lusaka', 'country': 'Zambia', 'facility': 'Kalingalinga Clinic CRS', 'geoPoint': {'lat': -15.40669, 'lon': 28.28713}}, {'city': 'Harare', 'country': 'Zimbabwe', 'facility': 'UZ-Parirenyatwa CRS', 'geoPoint': {'lat': -17.82772, 'lon': 31.05337}}], 'overallOfficials': [{'name': 'Robert Gross, MD, MSCE', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Pennsylvania'}, {'name': 'Alberto La Rosa, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Asociación Civil Impacta Salud y Educación, Peru'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}