Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:11 PM
Study NCT ID:
NCT00337467
Status:
COMPLETED
Last Update Posted:
2010-07-19
First Post:
2006-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Phase IIIb Study to Evaluate the Effectiveness and Safety of Atazanavir/Ritonavir as Single Enhanced Protease Inhibitor Therapy in Human Immunodeficiency Virus (HIV)-Infected Subjects Evidencing Virologic Suppression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'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': 'D012897', 'term': 'Slow 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': 'C000718687', 'term': 'atazanavir, ritonavir drug combination'}, {'id': 'D000069446', 'term': 'Atazanavir Sulfate'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'title': 'BMS Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'ATV/RTV Monotherapy', 'description': 'ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)', 'otherNumAtRisk': 61, 'otherNumAffected': 25, 'seriousNumAtRisk': 61, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'TOOTH INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'HYPERCHOLESTEROLAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'HYPERTRIGLYCERIDAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'PERIPHERAL ISCHAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'SUICIDAL IDEATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'DYSTHYMIC DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'PSYCHOTIC DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'DEPRESSION SUICIDAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'ISCHAEMIC STROKE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'APPENDICITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'EYE INFECTION SYPHILITIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'TESTICULAR ATROPHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'MULTI-ORGAN FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'BLADDER CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment Failure Through Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atazanavir (ATV)/Ritonavir (RTV) Monotherapy', 'description': 'ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)'}], 'classes': [{'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.3', 'ciLowerLimit': '11.9', 'ciUpperLimit': '33.7', 'statisticalMethod': 'exact binomial methods', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Given the small sample size, the 95% confidence interval is made with exact binomial methods.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'Treatment Failure through Week 48 defined as virologic rebound (HIV RNA \\>=400 c/mL) on or before Week 48 or study discontinuation before Week 48. Virological rebound is defined as confirmed on-treatment HIV ribonucleic acid (RNA) \\>= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA \\>=400 c/mL followed by discontinuation of study therapy.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment Failure Through Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atazanavir (ATV)/Ritonavir (RTV) Monotherapy', 'description': 'ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)'}], 'classes': [{'title': 'HIV RNA >= 400 c/mL(n=61)', 'categories': [{'measurements': [{'value': '34.4', 'groupId': 'OG000'}]}]}, {'title': 'HIV RNA>=50 c/mL w/Baseline HIV RNA<50 c/mL (n=60)', 'categories': [{'measurements': [{'value': '43.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.4', 'ciLowerLimit': '22.7', 'ciUpperLimit': '47.7', 'statisticalMethod': 'exact binomial methods', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Given the small sample size, the 95% confidence interval is made with exact binomial methods.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 96', 'description': 'Treatment Failure through Week 96 defined as virologic rebound (HIV RNA \\>=400 c/mL) on or before Week 96 or study discontinuation before Week 96. In addition, treatment failure defined based on HIV RNA \\>= 50 c/mL, latter analysis performed on treated subjects with baseline HIV RNA \\< 50 c/mL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA \\> 50 c/mL.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Virological Rebound Through Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atazanavir (ATV)/Ritonavir (RTV) Monotherapy', 'description': 'ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)'}], 'classes': [{'title': 'HIV RNA >= 400 c/mL (n=61)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'HIV RNA>=50 c/mL w/Baseline HIV RNA<50 c/mL (n=60)', 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'Virological rebound is defined as confirmed on-treatment HIV RNA \\>= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA \\>=400 c/mL followed by discontinuation of study therapy. In addition, virologic rebound defined based on HIV RNA \\>=50 c/m, latter analysis performed on subjects with baseline HIV RNA \\< 50 c/mL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA \\> 50 c/mL.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Virological Rebound Through Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atazanavir (ATV)/Ritonavir (RTV) Monotherapy', 'description': 'ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)'}], 'classes': [{'title': 'HIV RNA >= 400 c/mL (n=61)', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000'}]}]}, {'title': 'HIV RNA>=50 c/mL w/Baseline HIV RNA<50 c/mL (n=60)', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 96', 'description': 'Virological rebound is defined as confirmed on-treatment HIV RNA \\>= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA \\>=400 c/mL followed by discontinuation of study therapy. In addition, virologic rebound defined based on HIV RNA \\>=50 c/m, latter analysis performed on subjects with baseline HIV RNA \\< 50 c/mL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA \\> 50 c/mL.'}, {'type': 'SECONDARY', 'title': 'Cumulative Proportion of Participants Without Treatment Failure Through Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Proportion of Participants', 'description': 'Proportion of participants without treatment failure at the end of interval'}], 'classes': [{'title': 'Interval Week 4 - 8 (n=61)', 'categories': [{'measurements': [{'value': '0.9836', 'groupId': 'OG000'}]}]}, {'title': 'Interval Week 8 - 12 (n=60)', 'categories': [{'measurements': [{'value': '0.9508', 'groupId': 'OG000'}]}]}, {'title': 'Interval Week 12 - 16 (n=58)', 'categories': [{'measurements': [{'value': '0.9016', 'groupId': 'OG000'}]}]}, {'title': 'Interval Week 16 - 20 (n=55)', 'categories': [{'measurements': [{'value': '0.8852', 'groupId': 'OG000'}]}]}, {'title': 'Interval Week 20 - 24 (n=54)', 'categories': [{'measurements': [{'value': '0.8689', 'groupId': 'OG000'}]}]}, {'title': 'Interval Week 24 - 28 (n=53)', 'categories': [{'measurements': [{'value': '0.8525', 'groupId': 'OG000'}]}]}, {'title': 'Interval Week 32 - 36 (n=52)', 'categories': [{'measurements': [{'value': '0.8197', 'groupId': 'OG000'}]}]}, {'title': 'Interval Week 36 - 40 (n=50)', 'categories': [{'measurements': [{'value': '0.7869', 'groupId': 'OG000'}]}]}, {'title': 'Interval Week 48 - 52 (n=48)', 'categories': [{'measurements': [{'value': '0.7541', 'groupId': 'OG000'}]}]}, {'title': 'Interval Week 56 - 60 (n=46)', 'categories': [{'measurements': [{'value': '0.7377', 'groupId': 'OG000'}]}]}, {'title': 'Interval Week 64 - 68 (n=45)', 'categories': [{'measurements': [{'value': '0.7049', 'groupId': 'OG000'}]}]}, {'title': 'Interval Week 68 - 72 (n=43)', 'categories': [{'measurements': [{'value': '0.6885', 'groupId': 'OG000'}]}]}, {'title': 'Interval Week 72 - 76 (n=42)', 'categories': [{'measurements': [{'value': '0.6721', 'groupId': 'OG000'}]}]}, {'title': 'Interval Week 84 - 88 (n=41)', 'categories': [{'measurements': [{'value': '0.6557', 'groupId': 'OG000'}]}]}, {'title': 'Interval Week 92 - 96 (n=40)', 'categories': [{'measurements': [{'value': '0.6557', 'groupId': 'OG000'}]}]}, {'title': 'Interval Week 96 - 100 (n=31)', 'categories': [{'measurements': [{'value': '0.6557', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through Week 100', 'description': 'This Kaplan-Meier life table reports the cumulative proportion of participants without treatment failure up to the end of the respective time interval. Failure time is measured from the start of study therapy, and is based on the earliest event defining failure (virologic rebound at or before Week 96, or discontinuation prior to Week 96).', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'treated participants; n= the number at risk entering interval'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Virologic Rebound Through Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Proportion of Participants', 'description': 'Proportion of participants without virologic rebound at the end of interval'}], 'paramType': 'NUMBER', 'timeFrame': 'Through Week 96', 'description': 'Virologic rebound is defined as confirmed on-study HIV RNA ≥ 400 c/mL or last on-study HIV RNA ≥ 400 c/mL followed by treatment discontinuation.', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was not done; however, percentage of participants with virologic rebound through Weeks 48 and 96 are reported in Secondary Outcome Measures 3 and 4. Time to reatment failure (defined as the earlier of virologic rebound or treatment discontinuation) is reported in Secondary Outcome Measure 5.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.', 'description': 'ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)'}], 'classes': [{'title': 'Baseline Value (n=61)', 'categories': [{'measurements': [{'value': '559', 'spread': '272.8', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 24 (n=51)', 'categories': [{'measurements': [{'value': '61', 'spread': '173.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Change (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '61', 'ciLowerLimit': '12.3', 'ciUpperLimit': '109.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '24.3', 'statisticalMethod': 'normal approximation for 95% CI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'cells /mm3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'n=number of participants with CD4 cell count at baseline and at Week 24'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in CD4 Cell Count at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.', 'description': 'ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)'}], 'classes': [{'title': 'Baseline Value (n=61)', 'categories': [{'measurements': [{'value': '559', 'spread': '272.8', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 48 (n=46)', 'categories': [{'measurements': [{'value': '53', 'spread': '203.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Change (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '53', 'ciLowerLimit': '-7.1', 'ciUpperLimit': '113.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '30.0', 'statisticalMethod': 'normal approximation for 95% CI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'unitOfMeasure': 'cells /mm3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'n=number of participants with CD4 cell count at baseline and at Week 48.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in CD4 Cell Count at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.', 'description': 'ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)'}], 'classes': [{'title': 'Baseline Value (n=61)', 'categories': [{'measurements': [{'value': '559', 'spread': '272.8', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 96 (n=40)', 'categories': [{'measurements': [{'value': '63', 'spread': '208.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Change (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '63', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '129.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '32.9', 'statisticalMethod': 'normal approximation for 95% CI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 96', 'unitOfMeasure': 'cells /mm3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'n=number of participants with CD4 cell count at baseline and at Week 96.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.', 'description': 'ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)'}], 'classes': [{'title': 'All Grades AEs', 'categories': [{'measurements': [{'value': '75.4', 'groupId': 'OG000'}]}]}, {'title': 'All Grades AEs Related to Study Therapy', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 to Grade 4 AEs', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 to Grade 4 AEs Related to Study Therapy', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}]}]}, {'title': 'SAEs Related to Study Therapy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AEs Leading to Discontinuation', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}]}]}, {'title': 'Lipodystrophy-Related AEs', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline through Week 96', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition that does not necessarily have a causal relationship to treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. AE grades are: mild (1), moderate (2), severe (3), life-threatening (4), and death (5).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Participants'}, {'type': 'SECONDARY', 'title': 'Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.', 'description': 'ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)'}], 'classes': [{'title': 'Total Cholesterol (n=36)', 'categories': [{'measurements': [{'value': '9', 'spread': '18.0', 'groupId': 'OG000'}]}]}, {'title': 'HDL Cholesterol (n=35)', 'categories': [{'measurements': [{'value': '2', 'spread': '18.5', 'groupId': 'OG000'}]}]}, {'title': 'Non-HDL Cholesterol (n=35)', 'categories': [{'measurements': [{'value': '12', 'spread': '24.4', 'groupId': 'OG000'}]}]}, {'title': 'LDL Cholesterol (n=33)', 'categories': [{'measurements': [{'value': '20', 'spread': '33.4', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides (n=36)', 'categories': [{'measurements': [{'value': '17', 'spread': '51.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Change', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9', 'ciLowerLimit': '2.5', 'ciUpperLimit': '14.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.0', 'groupDescription': 'Percent Change from Baseline in Fasting Total Cholesterol at Week 48', 'statisticalMethod': 'normal approximation for 95% CI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Change', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '8.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.1', 'groupDescription': 'Percent Change from Baseline in Fasting HDL Cholesterol at Week 48', 'statisticalMethod': 'normal approximation for 95% CI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Change', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12', 'ciLowerLimit': '4.0', 'ciUpperLimit': '20.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.1', 'groupDescription': 'Percent Change from Baseline in Fasting Non-HDL Cholesterol at Week 48', 'statisticalMethod': 'normal approximation for 95% CI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Change', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20', 'ciLowerLimit': '8.0', 'ciUpperLimit': '31.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.8', 'groupDescription': 'Percent Change from Baseline in Fasting LDL Cholesterol at Week 48', 'statisticalMethod': 'normal approximation for 95% CI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Change', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '34.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.6', 'groupDescription': 'Percent Change from Baseline in Fasting Triglycerides at Week 48', 'statisticalMethod': 'normal approximation for 95% CI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'description': 'Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'n= number of treated participants with baseline measure and measure at Week 48'}, {'type': 'SECONDARY', 'title': 'Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.', 'description': 'ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)'}], 'classes': [{'title': 'Total Cholesterol (n=29)', 'categories': [{'measurements': [{'value': '14', 'spread': '17.4', 'groupId': 'OG000'}]}]}, {'title': 'HDL Cholesterol (n=29)', 'categories': [{'measurements': [{'value': '2', 'spread': '21.2', 'groupId': 'OG000'}]}]}, {'title': 'Non-HDL Cholesterol (n=29)', 'categories': [{'measurements': [{'value': '19', 'spread': '23.7', 'groupId': 'OG000'}]}]}, {'title': 'LDL Cholesterol (n=28)', 'categories': [{'measurements': [{'value': '29', 'spread': '34.4', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides (n=29)', 'categories': [{'measurements': [{'value': '16', 'spread': '67.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Change', 'ciPctValue': '95', 'paramValue': '14', 'ciLowerLimit': '6.9', 'ciUpperLimit': '20.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.2', 'groupDescription': 'Percent Change from Baseline in Fasting Total Cholesterol at Week 96', 'statisticalMethod': 'normal approximation for 95% CI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Change', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2', 'ciLowerLimit': '-6.0', 'ciUpperLimit': '10.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.9', 'groupDescription': 'Percent Change from Baseline in Fasting HDL Cholesterol at Week 96', 'statisticalMethod': 'normal approximation for 95% CI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Change', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19', 'ciLowerLimit': '10.3', 'ciUpperLimit': '28.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.4', 'groupDescription': 'Percent Change from Baseline in Fasting Non-HDL Cholesterol at Week 96', 'statisticalMethod': 'normal approximation for 95% CI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Change', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29', 'ciLowerLimit': '15.3', 'ciUpperLimit': '42.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.5', 'groupDescription': 'Percent Change from Baseline in Fasting LDL Cholesterol at Week 96', 'statisticalMethod': 'normal approximation for 95% CI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Change', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16', 'ciLowerLimit': '-9.5', 'ciUpperLimit': '41.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.5', 'groupDescription': 'Percent Change from Baseline in Fasting Triglycerides at Week 96', 'statisticalMethod': 'normal approximation for 95% CI', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 96', 'description': 'Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'n=number of treated participants with baseline measure and measure at Week 96'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.', 'description': 'ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)'}], 'classes': [{'title': 'IAS-USA-defined major PI substitutions', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'RT substitutions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. Reverse Transcriptase (RT) are TAMS and M184V.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with virologic rebounds (HIV-RNA ≥ 400 c/mL) through Week 48.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atazanavir (ATV)/Ritonavir (RTV) Monotherapy', 'description': 'ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)'}], 'classes': [{'title': 'IAS-USA-defined major PI substitutions', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'RT substitutions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 96', 'description': 'International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. Reverse Transcriptase (RT) are TAMS and M184V.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with virologic rebounds (HIV-RNA ≥ 400 c/mL) through Week 96.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.', 'description': 'ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}]}, {'type': 'Discontinued Prior to Week 96', 'achievements': [{'comment': '5 of these participants discontinued prior to Week 48', 'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Subject Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Subject No Longer Met Study Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': '63 participants were enrolled in this study; 2 were never treated (1 no longer met study criteria and 1 concomitant medication not permitted).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.', 'description': 'ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43', 'spread': '9.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cluster of Differentiation 4 (CD4) Categories', 'classes': [{'title': 'CD4 Count <200 cells/mm3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'CD4 Count >=200 cells/mm3', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Human Immunodeficiency Ribonucleic Acid (HIV RNA) Categories', 'classes': [{'title': 'HIV RNA <50 c/mL', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}, {'title': 'HIV RNA >=50 c/mL', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'CD4 Count', 'classes': [{'categories': [{'measurements': [{'value': '559', 'spread': '272.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cell/mm3', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting High-Density Lipoprotein (HDL) Cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '45', 'spread': '10.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Population analyzed = 54 (treated participants with baseline measure)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Low-Density Lipoprotein (LDL) Cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '112', 'spread': '52.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Population analyzed = 54 (treated participants with baseline measure)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Non-HDL Cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '144', 'spread': '57.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Population analyzed = 54 (treated participants with baseline measure)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Total Cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '189', 'spread': '57', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Population analyzed = 54 (treated participants with baseline measure)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Triglycerides', 'classes': [{'categories': [{'measurements': [{'value': '164', 'spread': '95.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Population analyzed = 54 (treated participants with baseline measure)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HIV RNA', 'classes': [{'categories': [{'measurements': [{'value': '1.71', 'spread': '0.152', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 c/mL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-18', 'studyFirstSubmitDate': '2006-06-14', 'resultsFirstSubmitDate': '2010-05-21', 'studyFirstSubmitQcDate': '2006-06-15', 'lastUpdatePostDateStruct': {'date': '2010-07-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-06-18', 'studyFirstPostDateStruct': {'date': '2006-06-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Treatment Failure Through Week 48', 'timeFrame': 'Week 48', 'description': 'Treatment Failure through Week 48 defined as virologic rebound (HIV RNA \\>=400 c/mL) on or before Week 48 or study discontinuation before Week 48. Virological rebound is defined as confirmed on-treatment HIV ribonucleic acid (RNA) \\>= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA \\>=400 c/mL followed by discontinuation of study therapy.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Treatment Failure Through Week 96', 'timeFrame': 'Week 96', 'description': 'Treatment Failure through Week 96 defined as virologic rebound (HIV RNA \\>=400 c/mL) on or before Week 96 or study discontinuation before Week 96. In addition, treatment failure defined based on HIV RNA \\>= 50 c/mL, latter analysis performed on treated subjects with baseline HIV RNA \\< 50 c/mL.'}, {'measure': 'Percentage of Participants With Virological Rebound Through Week 48', 'timeFrame': 'Week 48', 'description': 'Virological rebound is defined as confirmed on-treatment HIV RNA \\>= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA \\>=400 c/mL followed by discontinuation of study therapy. In addition, virologic rebound defined based on HIV RNA \\>=50 c/m, latter analysis performed on subjects with baseline HIV RNA \\< 50 c/mL.'}, {'measure': 'Percentage of Participants With Virological Rebound Through Week 96', 'timeFrame': 'Week 96', 'description': 'Virological rebound is defined as confirmed on-treatment HIV RNA \\>= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA \\>=400 c/mL followed by discontinuation of study therapy. In addition, virologic rebound defined based on HIV RNA \\>=50 c/m, latter analysis performed on subjects with baseline HIV RNA \\< 50 c/mL.'}, {'measure': 'Cumulative Proportion of Participants Without Treatment Failure Through Week 100', 'timeFrame': 'Through Week 100', 'description': 'This Kaplan-Meier life table reports the cumulative proportion of participants without treatment failure up to the end of the respective time interval. Failure time is measured from the start of study therapy, and is based on the earliest event defining failure (virologic rebound at or before Week 96, or discontinuation prior to Week 96).'}, {'measure': 'Proportion of Participants With Virologic Rebound Through Week 96', 'timeFrame': 'Through Week 96', 'description': 'Virologic rebound is defined as confirmed on-study HIV RNA ≥ 400 c/mL or last on-study HIV RNA ≥ 400 c/mL followed by treatment discontinuation.'}, {'measure': 'Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Mean Change From Baseline in CD4 Cell Count at Week 48', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Mean Change From Baseline in CD4 Cell Count at Week 96', 'timeFrame': 'Baseline, Week 96'}, {'measure': 'Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs', 'timeFrame': 'From Baseline through Week 96', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition that does not necessarily have a causal relationship to treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. AE grades are: mild (1), moderate (2), severe (3), life-threatening (4), and death (5).'}, {'measure': 'Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48', 'timeFrame': 'Baseline, Week 48', 'description': 'Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.'}, {'measure': 'Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 96', 'timeFrame': 'Baseline, Week 96', 'description': 'Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.'}, {'measure': 'Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 48', 'timeFrame': 'Week 48', 'description': 'International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. Reverse Transcriptase (RT) are TAMS and M184V.'}, {'measure': 'Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96', 'timeFrame': 'Week 96', 'description': 'International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. Reverse Transcriptase (RT) are TAMS and M184V.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV-Infected Patients Evidencing Virologic Suppression'], 'conditions': ['Human Immunodeficiency Virus (HIV) Infections']}, 'descriptionModule': {'briefSummary': 'The main purpose is to explore whether atazanavir/ritonavir (ATV/RTV) single enhanced protease inhibitor therapy can maintain virologic suppression without a marked increase in virologic failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* On continued antiretroviral (ARV) treatment, with no discontinuation periods, for the previous 6 months (24 weeks).\n* Absence of evidence or suspected virologic failure on antiretroviral therapy\n* Absence of known primary mutations in the protease gene\n* Only 1 highly active antiretroviral therapy (HAART) prior to current one\n* HIV RNA \\< 50 copies/mL in the last 6 months (single blip below 200 c/mL allowed)\n* On ATV/RTV +2 nucleoside reverse transcriptase inhibitors (NRTIs) (or 1 NRTI + tenofovir \\[TDF\\]) for at least 8 weeks before study entry, without treatment-limiting adverse effects\n\nExclusion Criteria:\n\n* Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment.\n* Active disease condition (e.g. moderate to severe hepatic impairment/active renal disease/history of clinically significant heart conduction disease)\n* Patients with chronic hepatitis B receiving lamivudine (3TC), Tenofovir Disoproxil Fumarate (TDF) or emtricitabine (FTC).\n* CD4 \\< 100 cells/mm3\n* Grade IV laboratory values: Hemoglobin \\< 6.5 g/dL or white blood cells (WBC) \\<800/mmm3 or absolute neutrophil count \\< 500/mm3, or platelets \\< 20,000/mm3 or diffuse petechiae.'}, 'identificationModule': {'nctId': 'NCT00337467', 'acronym': 'OREY', 'briefTitle': 'Phase IIIb Study to Evaluate the Effectiveness and Safety of Atazanavir/Ritonavir as Single Enhanced Protease Inhibitor Therapy in Human Immunodeficiency Virus (HIV)-Infected Subjects Evidencing Virologic Suppression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Phase IIIb Multicenter, Single Arm, Open-Label Pilot Study to Evaluate the Effectiveness and Safety of Maintenance With Atazanavir/Ritonavir as Single Enhanced Protease Inhibitor Therapy in HIV-Infected Patients Evidencing Virologic Suppression OREY (Only REYataz) Study', 'orgStudyIdInfo': {'id': 'AI424-227'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A1', 'interventionNames': ['Drug: Atazanavir + Ritonavir']}], 'interventions': [{'name': 'Atazanavir + Ritonavir', 'type': 'DRUG', 'otherNames': ['Reyataz', 'BMS-232632'], 'description': 'Capsules, Oral, ATV 300mg + RTV 100mg, once daily, 96 weeks', 'armGroupLabels': ['A1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'Bristol-Myers Squibb'}}}}