Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-02-25 @ 5:35 PM
Study NCT ID:
NCT00135356
Status:
COMPLETED
Last Update Posted:
2010-05-07
First Post:
2005-08-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands']}, 'conditionBrowseModule': {'meshes': [{'id': 'D039682', 'term': 'HIV-Associated Lipodystrophy Syndrome'}, {'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': 'D008060', 'term': 'Lipodystrophy'}, {'id': 'D012875', 'term': 'Skin Diseases, Metabolic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069446', 'term': 'Atazanavir Sulfate'}, {'id': 'D019438', 'term': 'Ritonavir'}], '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'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}]}}, '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 Switch Arm', 'otherNumAtRisk': 131, 'otherNumAffected': 94, 'seriousNumAtRisk': 131, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'PI/RTV Control Arm', 'otherNumAtRisk': 69, 'otherNumAffected': 35, 'seriousNumAtRisk': 69, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'BLOOD BILIRUBIN INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'JAUNDICE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'HYPERBILIRUBINAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'PHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'HYPERTRIGLYCERIDAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'DRUG ABUSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'DRUG DEPENDENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'JAUNDICE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'HYPERBILIRUBINAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'PARALYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'CONVULSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'CEREBROVASCULAR ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'IRRITABLE BOWEL SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'NEUROSYPHILIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'CALCULUS BLADDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'STEVENS-JOHNSON SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'BENIGN PROSTATIC HYPERPLASIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'JAW FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'DRUG TOXICITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'INTERVERTEBRAL DISC PROTRUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'PROSTATE CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'SQUAMOUS CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Trunk-to-limb Fat Ratio as Measured by Dual Energy X-Ray Absortiometry (DEXA) at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV/RTV Switch Arm', 'description': 'Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).'}, {'id': 'OG001', 'title': 'PI/RTV Control Arm', 'description': 'Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.'}], 'classes': [{'title': 'LOCF Population (n=112; n=54)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.027', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.036', 'groupId': 'OG001'}]}]}, {'title': 'OCPopulation (n=105; n=51)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.029', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.038', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.48', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Means', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.12', 'pValueComment': 'P-value not adjusted for multiple testing, 2-sided 95% CI', 'groupDescription': 'LOCF', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.57', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Means', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '12.0', 'pValueComment': 'P-value not adjusted for multiple testing. 2-sided 95% CI', 'groupDescription': 'OC', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'description': 'Mean changes from Baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values. (Baseline trunk-to-limb fat ratio values can be found in the Baseline Characteristics section.)', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants. Observed case (OC) analysis: n=participants with fat measurement at baseline and at the analysis timepoint. Last observation carried forward (LOCF): n=participants with fat measurement at baseline and at or before the analysis timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Trunk-to-limb Fat Ratio as Measured by DEXA at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV/RTV Switch Arm', 'description': 'Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).'}, {'id': 'OG001', 'title': 'PI/RTV Control Arm', 'description': 'Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.'}], 'classes': [{'title': 'LOCF Population (n=112; n=54)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.035', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.046', 'groupId': 'OG001'}]}]}, {'title': 'OC Population (n=94; n=45)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.041', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.051', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.73', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Means', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.14', 'pValueComment': 'P-value not adjusted for multiple testing, 2-sided 95% CI.', 'groupDescription': 'LOCF', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.91', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Means', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.13', 'pValueComment': 'P-value not adjusted for multiple testing, 2-sided 95% CI.', 'groupDescription': 'OC', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 96', 'description': 'Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values.(Baseline trunk-to-limb fat ratio values can be found in the Baseline Characteristics section.)', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Observed case (OC) analysis: n=participants with fat measurement at baseline and at the analysis timepoint. Last observation carried forward (LOCF): n=participants with fat measurement at baseline and at or before the analysis timepoint.'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change From Baseline in Visceral Adipose Tissue (VAT) Area by Computed Tomography (CT) Scans and in Trunk Fat by DEXA.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV/RTV Switch Arm', 'description': 'Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).'}, {'id': 'OG001', 'title': 'PI/RTV Control Arm', 'description': 'Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.'}], 'classes': [{'title': 'Week 48 VAT (n=98; n=53)', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '-13.8', 'upperLimit': '25.7'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-10.8', 'upperLimit': '14.6'}]}]}, {'title': 'Week 96 VAT (n=101; n=53)', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '-11.7', 'upperLimit': '26.5'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '-12.4', 'upperLimit': '23.3'}]}]}, {'title': 'Week 48 Trunk Fat (n=112; n=57)', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '-5.8', 'upperLimit': '12.4'}, {'value': '-1.8', 'groupId': 'OG001', 'lowerLimit': '-10.0', 'upperLimit': '9.2'}]}]}, {'title': 'Week 96 Trunk Fat (n=112; n=57)', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '-6.7', 'upperLimit': '14.3'}, {'value': '-3.6', 'groupId': 'OG001', 'lowerLimit': '-12.9', 'upperLimit': '9.5'}]}]}], 'analyses': [{'pValue': '0.27', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Mean', 'ciPctValue': '95', 'paramValue': '5.2', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '15.1', 'pValueComment': 'P-value not adjusted for multiple testing, 2-sided 95% CI.', 'groupDescription': 'Week 48 VAT LOCF', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.68', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Mean', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '-6.7', 'ciUpperLimit': '11.2', 'pValueComment': 'P-value not adjusted for multiple testing, 2-sided 95% CI', 'groupDescription': 'VAT, Week 96 LOCF', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.14', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Means', 'ciPctValue': '95', 'paramValue': '4.4', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '10.6', 'pValueComment': 'P-value not adjusted for multiple testing, 2-sided 95% CI.', 'groupDescription': 'Week 48 Trunk Fat LOCF', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.14', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Means', 'ciPctValue': '95', 'paramValue': '5.3', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '12.9', 'pValueComment': 'P-value not adjusted for multiple testing, 2-sided 95% CI.', 'groupDescription': 'Week 96 Trunk Fat LOCF', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48, Week 96', 'description': 'The mean percent change from baseline in physical signs of lipohypertrophy, as assessed objectively by changes in visceral adipose tissue (VAT) area (cm2) by computed tomography (CT) scans and by changes in trunk fat (kg) by DEXA. Clinical improvement is associated with a decrease in values. (Baseline values can be found in the Baseline Characteristics section.)', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'VAT analysis population=treated subjects with adipose tissue pairs (LOCF); trunk fat analysis population=treated subjects with fat pairs (LOCF); n=number of subjects with measurement at baseline and at or before the analysis timepoint.'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change From Baseline in Peripheral Adipose Tissue (Limb Fat) by DEXA and by Changes in Subcutaneous Adipose Tissue (SAT) Area by CT Scans', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV/RTV Switch Arm', 'description': 'Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).'}, {'id': 'OG001', 'title': 'PI/RTV Control Arm', 'description': 'Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.'}], 'classes': [{'title': 'Week 48 SAT (n=108; n=59)', 'categories': [{'measurements': [{'value': '-2.2', 'groupId': 'OG000', 'lowerLimit': '-11.6', 'upperLimit': '8.7'}, {'value': '-5.9', 'groupId': 'OG001', 'lowerLimit': '-14.4', 'upperLimit': '5.8'}]}]}, {'title': 'Week 96 SAT (n=111; n=59)', 'categories': [{'measurements': [{'value': '-3.5', 'groupId': 'OG000', 'lowerLimit': '-15.7', 'upperLimit': '8.7'}, {'value': '-9.7', 'groupId': 'OG001', 'lowerLimit': '-21.6', 'upperLimit': '6.6'}]}]}, {'title': 'Week 48 Limb Fat (n=112; 54)', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '-7.4', 'upperLimit': '10.5'}, {'value': '-3.6', 'groupId': 'OG001', 'lowerLimit': '-15.5', 'upperLimit': '7.5'}]}]}, {'title': 'Week 48 Limb Fat (n=112; n=54)', 'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000', 'lowerLimit': '-11.3', 'upperLimit': '12.2'}, {'value': '-6.1', 'groupId': 'OG001', 'lowerLimit': '-19.8', 'upperLimit': '8.7'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Means', 'ciPctValue': '95', 'paramValue': '4.0', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '10.0', 'pValueComment': 'P-value not adjusted for multiple testing, 2-sided 95% CI.', 'groupDescription': 'SAT, Week 48, LOCF', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Mean', 'ciPctValue': '95', 'paramValue': '6.8', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '14.2', 'pValueComment': 'P-value not adjusted for multiple testing, 2-sided 95% CI.', 'groupDescription': 'Week 96 SAT', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.15', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Means', 'ciPctValue': '95', 'paramValue': '4.6', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '11.4', 'pValueComment': 'P-value not adjusted for multiple testing, 2-sided 95% CI.', 'groupDescription': 'Week 48, Limb Fat', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Means', 'ciPctValue': '95', 'paramValue': '5.7', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '14.4', 'pValueComment': 'P-value not adjusted for multiple testing, 2-sided 95% CI', 'groupDescription': 'Week 96, Limb Fat', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48, Week 96', 'description': 'The mean percent change from baseline in physical signs of lipoatrophy, as assessed objectively by changes in peripheral adipose tissue (ie, limb fat (kg) by DEXA and in subcutaneous adipose tissue (SAT) area by CT scans. Clinical improvement is associated with stable values, or an increase in values. (Baseline values can be found in the Baseline Characteristics section.)', 'unitOfMeasure': 'percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'SAT analysis population=treated subjects with adipose tissue pairs (LOCF); trunk fat analysis population=treated subjects with fat pairs (LOCF); n=number of subjects with measurement at baseline and at or before analysis timepoint.'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change From Baseline in Total Body Fat by DEXA and in Total Adipose Tissue (TAT) Area by CT Scans', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV/RTV Switch Arm', 'description': 'Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).'}, {'id': 'OG001', 'title': 'PI/RTV Control Arm', 'description': 'Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.'}], 'classes': [{'title': 'Week 48 TAT (n=108; n= 59)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-9.0', 'upperLimit': '10.8'}, {'value': '-3.5', 'groupId': 'OG001', 'lowerLimit': '-12.7', 'upperLimit': '10.0'}]}]}, {'title': 'Week 96 TAT (n=111; n=59)', 'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000', 'lowerLimit': '-9.2', 'upperLimit': '12.7'}, {'value': '-5.0', 'groupId': 'OG001', 'lowerLimit': '-16.0', 'upperLimit': '10.4'}]}]}, {'title': 'Week 48 Total Body Fat (n=105; n=51)', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '-5.4', 'upperLimit': '11.5'}, {'value': '-3.7', 'groupId': 'OG001', 'lowerLimit': '-10.9', 'upperLimit': '5.1'}]}]}, {'title': 'Week 96 Total Body Fat (n=94; n=45)', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-9.5', 'upperLimit': '11.8'}, {'value': '-7.4', 'groupId': 'OG001', 'lowerLimit': '-16.9', 'upperLimit': '6.6'}]}]}], 'analyses': [{'pValue': '0.19', 'groupIds': ['OG000', 'OG001'], 'paramType': 'DIfference in Means', 'ciPctValue': '95', 'paramValue': '3.6', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '9.4', 'pValueComment': 'P-value not adjusted for multiple testing, 2-sided 95% CI.', 'groupDescription': 'Week 48 TAT', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'paramType': 'DIfference in Means', 'ciPctValue': '95', 'paramValue': '4.3', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '10.7', 'pValueComment': 'P-value not adjusted for multiple testing, 2-sided 95% CI.', 'groupDescription': 'Week 96 TAT', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0385', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Means', 'ciPctValue': '95', 'paramValue': '5.0', 'ciLowerLimit': '0.3', 'ciUpperLimit': '9.7', 'pValueComment': 'P-value not adjusted for multiple testing, 2-sided 95% CI.', 'groupDescription': 'Week 48 Total Body Fat', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Means', 'ciPctValue': '95', 'paramValue': '5.9', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '13.2', 'pValueComment': 'P-value not adjusted for multiple testing, 2-sided 95% CI.', 'groupDescription': 'Week 96 Total Body Fat', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48, Week 96', 'description': 'The mean percent change from baseline in total body fat by DEXA and in total adipose tissue (TAT) area by CT scans. Total body fat and TAT are both associated many factors (trunk fat + limb fat + other \\[weight, etc\\]), and thus clinical improvement cannot be predicted based solely an increase or decrease of these values. (Baseline values can be found in the Baseline Characteristics section.)', 'unitOfMeasure': 'percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'TAT analysis population=treated subjects with adipose tissue pairs (LOCF); trunk fat analysis population=treated subjects with fat pairs (LOCF); n=number of subjects with measurement at baseline and at or before the analysis timepoint'}, {'type': 'SECONDARY', 'title': 'Mean Percent Changes From Baseline in Fasting Lipids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV/RTV Switch Arm', 'description': 'Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).'}, {'id': 'OG001', 'title': 'PI/RTV Control Arm', 'description': 'Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.'}], 'classes': [{'title': 'Week 48 - Total Cholesterol', 'categories': [{'measurements': [{'value': '-13.0', 'groupId': 'OG000'}, {'value': '-1.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 - HDL Cholesterol', 'categories': [{'measurements': [{'value': '-6.2', 'groupId': 'OG000'}, {'value': '-2.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 - Non-HDL Cholesterol', 'categories': [{'measurements': [{'value': '-14.8', 'groupId': 'OG000'}, {'value': '-0.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 - LDL Cholesterol', 'categories': [{'measurements': [{'value': '-10.4', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 - Triglycerides', 'categories': [{'measurements': [{'value': '-23.8', 'groupId': 'OG000'}, {'value': '-11.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 - Apolipoprotein B', 'categories': [{'measurements': [{'value': '-7.6', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 96 - Total Cholesterol', 'categories': [{'measurements': [{'value': '-12.5', 'groupId': 'OG000'}, {'value': '-0.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 96 - HDL Cholesterol', 'categories': [{'measurements': [{'value': '-6.8', 'groupId': 'OG000'}, {'value': '-4.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 96 - Non-HDL Cholesterol', 'categories': [{'measurements': [{'value': '-14.0', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 96 - LDL Cholesterol', 'categories': [{'measurements': [{'value': '-8.4', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 96 - Triglycerides', 'categories': [{'measurements': [{'value': '-25.0', 'groupId': 'OG000'}, {'value': '-12.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 96 - Apolipoprotein B', 'categories': [{'measurements': [{'value': '-8.3', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 48, Week 96', 'description': 'Mean percent changes from baseline in fasting total, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and non-HDL cholesterol, triglycerides, and apolipoprotein B', 'unitOfMeasure': 'Percent change', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Subjects (LOCF). n=56 for LDL cholesterol in the PI/RTV arm at both timepoints'}, {'type': 'SECONDARY', 'title': 'Mean Changes From Baseline in Fasting Glucose at Week 48 and Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV/RTV Switch Arm', 'description': 'Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).'}, {'id': 'OG001', 'title': 'PI/RTV Control Arm', 'description': 'Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.'}], 'classes': [{'title': 'Week 48 (n=124; n=63)', 'categories': [{'measurements': [{'value': '3.6', 'spread': '2.60', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '2.92', 'groupId': 'OG001'}]}]}, {'title': 'Week 96 (n=124; n=64)', 'categories': [{'measurements': [{'value': '1.2', 'spread': '2.82', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '2.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48, Week 96', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants (LOCF); n=number of participants with baseline value at or before analysis timepoint.'}, {'type': 'SECONDARY', 'title': 'Mean Changes From Baseline in Fasting Insulin at Week 48 and Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV/RTV Switch Arm', 'description': 'Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).'}, {'id': 'OG001', 'title': 'PI/RTV Control Arm', 'description': 'Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.'}], 'classes': [{'title': 'Baseline (n=124; n=62)', 'categories': [{'measurements': [{'value': '14.1', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '21.8', 'spread': '3.36', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 (n=124; n=59)', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '3.79', 'groupId': 'OG001'}]}]}, {'title': 'Week 96 (n=124; n=59)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '4.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48, Week 96', 'unitOfMeasure': 'microunits per milliliter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants (LOCF); n=number of participants with baseline value at or before analysis timepoint.'}, {'type': 'SECONDARY', 'title': 'Mean Changes From Baseline in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV/RTV Switch Arm', 'description': 'Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).'}, {'id': 'OG001', 'title': 'PI/RTV Control Arm', 'description': 'Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.'}], 'classes': [{'title': 'Baseline (n=115; n=59)', 'categories': [{'measurements': [{'value': '3.42', 'spread': '0.309', 'groupId': 'OG000'}, {'value': '5.43', 'spread': '1.233', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 (n=115; n=57)', 'categories': [{'measurements': [{'value': '0.74', 'spread': '0.589', 'groupId': 'OG000'}, {'value': '-1.73', 'spread': '1.223', 'groupId': 'OG001'}]}]}, {'title': 'Week 96 (n=115; n=57)', 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.500', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '1.648', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48, Week 96', 'description': 'HOMA-IR is an index used in evaluation of obese patients at risk for type 2 diabetes which requires fasting glucose and insulin concentrations. It is a mathematical model based on the theory of a negative feedback loop between the liver and β-cells that regulates both fasting glucose and insulin concentrations and can be used to estimate pancreatic β-cell function and degree of insulin resistance. HOMA-IR normal values are between 2 and 2.5. HOMA-IR ≥ 2.5 indicates insulin-resistance.', 'unitOfMeasure': 'mg/dL x uU/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants (LOCF); n=number of participants with baseline value at or before analysis timepoint.'}, {'type': 'SECONDARY', 'title': 'Mean Changes From Baseline in Body Weight at Week 48 and Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV/RTV Switch Arm', 'description': 'Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).'}, {'id': 'OG001', 'title': 'PI/RTV Control Arm', 'description': 'Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.'}], 'classes': [{'title': 'Week 48 (n=130; n=68)', 'categories': [{'measurements': [{'value': '1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-1', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 96 (n=130; n=68)', 'categories': [{'measurements': [{'value': '0', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '-1', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48, Week 96', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF; n=number of participants with baseline value and value at or before analysis timepoint'}, {'type': 'SECONDARY', 'title': 'Mean Changes From Baseline in Waist Circumference at Week 48 and Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV/RTV Switch Arm', 'description': 'Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).'}, {'id': 'OG001', 'title': 'PI/RTV Control Arm', 'description': 'Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.'}], 'classes': [{'title': 'Week 48 (n=123; n=66)', 'categories': [{'measurements': [{'value': '-1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-1', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 96 (n=124; n=66)', 'categories': [{'measurements': [{'value': '-1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '-1', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48, Week 96', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF; n=number of participants with baseline value and value at or before analysis timepoint'}, {'type': 'SECONDARY', 'title': 'Mean Changes From Baseline in Body Mass Index at Week 48 and Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV/RTV Switch Arm', 'description': 'Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).'}, {'id': 'OG001', 'title': 'PI/RTV Control Arm', 'description': 'Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.'}], 'classes': [{'title': 'Week 48 (n=130; n=67)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Week 96 (n=130; n=67)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48, Week 96', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF; n=number of participants with baseline value and value at or before analysis timepoint'}, {'type': 'SECONDARY', 'title': 'Mean Changes From Baseline in Waist-to-Hip Ratio at Week 48 and Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV/RTV Switch Arm', 'description': 'Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).'}, {'id': 'OG001', 'title': 'PI/RTV Control Arm', 'description': 'Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.'}], 'classes': [{'title': 'Week 48 (n=123; n=65)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.005', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.007', 'groupId': 'OG001'}]}]}, {'title': 'Week 96 (n=124; n=65)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.006', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.007', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48, Week 96', 'description': 'Mean changes from baseline in proportion of waist to hip measurements.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'LOCF; n=number of participants with baseline value and value at or before analysis timepoint'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV/RTV Switch Arm', 'description': 'Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).'}, {'id': 'OG001', 'title': 'PI/RTV Control Arm', 'description': 'Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.'}], 'classes': [{'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'AE Leading to Discontinuation', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any AEs (all grades) through Week 96', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through Week 96 of study therapy', 'description': 'Percentage of Participants with AEs, Serious AEs (SAEs), Deaths, and AEs leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated participants'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Abnormal Liver Function Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV/RTV Switch Arm', 'description': 'Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).'}, {'id': 'OG001', 'title': 'PI/RTV Control Arm', 'description': 'Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.'}], 'classes': [{'title': 'Wk 48 ALT Grades 1-4', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Wk 48 ALT Grades 3-4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Wk 48 ALT Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Wk 96 ALT Grades 1-4', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Wk 96 ALT Grades 3-4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Wk 96 ALT Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Wk 48 AST Grade 1-4', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Wk 48 AST Grades 3-4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Wk 48 AST Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Wk 96 AST Grades 1-4', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Wk 96 AST Grades 3-4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Wk 96 AST Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Wk 48 TBILI Grades 1-4', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Wk 48 TBILI Grades 3-4', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Wk 48 TBILI Grade 4', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Wk 96 TBILI Grades 1-4', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Wk 96 TBILI Grades 3-4', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Wk 96 TBILI Grade 4', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48, Week 96', 'description': 'Percentage of participants with Abnormal Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Total Bilirubin (TBILI) measurements. Values for liver tests are graded using the modified World Health Organization (WHO) criteria. Grade 1 is mild, grade 2 is moderate, grade 3 is severe, grade 4 is life threatening or disabling.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV/RTV Switch Arm', 'description': 'Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).'}, {'id': 'OG001', 'title': 'PI/RTV Control Arm', 'description': 'Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.'}], 'classes': [{'title': 'Any adverse experience leading to discontinuation', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Hyperbilirubinemia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Jaundice', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Drug abuse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Renal impairment', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Stevens-Johnson syndrome', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypertriglyceridemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Squamous cell carcinoma', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through Week 96', 'description': 'Percentage of Participants with AEs leading to discontinuation of study therapy. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. All events listed in this table were SAEs, except for renal impairment and hypertriglycerideamia, which were an AEs (and did not meet the 5 percent threshold reported in Adverse Event module of this record).', 'unitOfMeasure': 'Percent of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated subjects'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Cumulative Proportion of Participants Without Virologic Rebound (HIV RNA ≥400 c/mL) at Timepoints up to Week 96 in Treated Participants With HIV RNA <400 c/mL at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV/RTV Switch Arm', 'description': 'Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).'}, {'id': 'OG001', 'title': 'PI/RTV Control Arm', 'description': 'Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.'}], 'classes': [{'title': 'By Weeks 8-12', 'categories': [{'measurements': [{'value': '0.9837', 'groupId': 'OG000', 'lowerLimit': '0.31', 'upperLimit': '22.68'}, {'value': '1.000', 'groupId': 'OG001'}]}]}, {'title': 'By Weeks 20-24', 'categories': [{'measurements': [{'value': '0.9837', 'groupId': 'OG000', 'lowerLimit': '0.30', 'upperLimit': '3.72'}, {'value': '1.000', 'groupId': 'OG001'}]}]}, {'title': 'By Weeks 32-36', 'categories': [{'measurements': [{'value': '0.9753', 'groupId': 'OG000'}, {'value': '0.9841', 'groupId': 'OG001'}]}]}, {'title': 'By Weeks 44-48', 'categories': [{'measurements': [{'value': '0.9669', 'groupId': 'OG000'}, {'value': '0.9841', 'groupId': 'OG001'}]}]}, {'title': 'By Weeks 56-60', 'categories': [{'measurements': [{'value': '0.9585', 'groupId': 'OG000'}, {'value': '0.9841', 'groupId': 'OG001'}]}]}, {'title': 'By Weeks 68-72', 'categories': [{'measurements': [{'value': '0.9585', 'groupId': 'OG000'}, {'value': '0.9841', 'groupId': 'OG001'}]}]}, {'title': 'By Weeks 80-84', 'categories': [{'measurements': [{'value': '0.9585', 'groupId': 'OG000'}, {'value': '0.9674', 'groupId': 'OG001'}]}]}, {'title': 'By Weeks 92-96', 'categories': [{'measurements': [{'value': '0.9585', 'groupId': 'OG000'}, {'value': '0.9309', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.3', 'ciUpperLimit': '3.72', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 8-12, Weeks 20-24, Weeks 32-36, Weeks 44-48, Weeks 56-60, Weeks 68-72, Weeks 80-84, Weeks 92-96', 'description': 'Virologic rebound was measured from the first dose of study therapy to the first of the 2 consecutive measurements ≥400 c/mL. Time to virologic rebound was analyzed using life tables. Measured Values show the Kaplan-Meier cumulative proportion of participants without virologic rebound up to the end of the respective interval.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated subjects with HIV RNA \\<400 c/mL at baseline.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in CD4 Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATV/RTV Switch Arm', 'description': 'Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).'}, {'id': 'OG001', 'title': 'PI/RTV Control Arm', 'description': 'Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.'}], 'classes': [{'title': 'Week 48 (n=114; n=56)', 'categories': [{'measurements': [{'value': '14', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '44', 'spread': '19.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 96 (n=96; n=54)', 'categories': [{'measurements': [{'value': '3', 'spread': '16.9', 'groupId': 'OG000'}, {'value': '82', 'spread': '22.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48, Week 96', 'description': 'Mean change from baseline in CD4 count among treated subjects', 'unitOfMeasure': 'cells/mm3', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Observed Cases (OC)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ATV/RTV Switch Arm', 'description': 'Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).'}, {'id': 'FG001', 'title': 'PI/RTV Control Arm', 'description': 'Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Number randomized and treated', 'groupId': 'FG000', 'numSubjects': '131'}, {'comment': 'Number randomized and treated(1 randomized and never treated subject not included in this number.)', 'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'Discontinued Prior to Week 96 Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Discontinued on or After Week 96 Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Surgery for abdominal fat', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Change in antiviral regimen', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Poor/noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'No longer meets study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': 'A total of 219 participants were enrolled and 18 were never randomized (1 poor/noncompliance; 10 no longer met study criteria; 5 withdrew consent). 201 participants were randomized; however, 1 participant was never treated and is not included in the participant flow.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ATV/RTV Switch Arm', 'description': 'Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).'}, {'id': 'BG001', 'title': 'PI/RTV Control Arm', 'description': 'Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '79'}, {'value': '42', 'groupId': 'BG001', 'lowerLimit': '26', 'upperLimit': '65'}, {'value': '43', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '79'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}, {'title': 'Mestizo', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'American Indian/Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Latino/Hispanic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Europe', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}, {'title': 'North America', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cluster of Differentiation 4 (CD4) Distribution', 'classes': [{'title': '50 to <100 cells/mm3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': '100 to <200 cells/mm3', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': '200 to <350 cells/mm3', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': '350 to <500 cells/mm3', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': '≥500 cells/mm3', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'CD4=a protein marker on the surface of certain types of T lymphocytes and other cells; HIV binds to CD4 receptors to enter host cells.', 'unitOfMeasure': 'Participants'}, {'title': 'Fasting Glucose', 'classes': [{'title': '<100 mg/dL', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000', 'lowerLimit': '83.0', 'upperLimit': '99.0'}, {'value': '49', 'groupId': 'BG001', 'lowerLimit': '82.0', 'upperLimit': '100.0'}, {'value': '145', 'groupId': 'BG002'}]}]}, {'title': '100 mg/dL to <126 mg/dL', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': '>=126 mg/dL', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': '7 participants in ATV/RTV arm and 3 participants in PI/RTV arm were missing this baseline measurement.', 'unitOfMeasure': 'participants'}, {'title': 'Fasting Lipids', 'classes': [{'title': 'Triglycerides <150 mg/dL', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000', 'lowerLimit': '41', 'upperLimit': '54'}, {'value': '14', 'groupId': 'BG001', 'lowerLimit': '35', 'upperLimit': '53'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'Triglycerides 150 mg/dL to <200 mg/dL', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000', 'lowerLimit': '139', 'upperLimit': '198'}, {'value': '9', 'groupId': 'BG001', 'lowerLimit': '126', 'upperLimit': '192'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'Triglycerides 200 mg/dL to <500 mg/dL', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000', 'lowerLimit': '90', 'upperLimit': '143'}, {'value': '27', 'groupId': 'BG001', 'lowerLimit': '84', 'upperLimit': '125'}, {'value': '79', 'groupId': 'BG002'}]}]}, {'title': 'Triglycerides >=500 mg/dL', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000', 'lowerLimit': '151', 'upperLimit': '326'}, {'value': '12', 'groupId': 'BG001', 'lowerLimit': '154', 'upperLimit': '425'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Non-HDL Cholesterol <130 mg/dL', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000', 'lowerLimit': '80', 'upperLimit': '111'}, {'value': '16', 'groupId': 'BG001', 'lowerLimit': '78', 'upperLimit': '111'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Non-HDL Cholesterol 130 mg/dL to <160 mg/dL', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'Non-HDL Cholesterol 160 mg/dL to <190 mg/dL', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Non-HDL Cholesterol 190 mg/dL to <220 mg/dL', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Non-HDL Cholesterol >=220 mg/dL', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'LDL Cholesterol <100 mg/dL', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': 'LDL Cholesterol 100 mg/dL to <130 mg/dL', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}, {'title': 'LDL Cholesterol 130 mg/dL to <160 mg/dL', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'LDL Cholesterol 160 mg/dL to <190 mg/dL', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'LDL Cholesterol >=190 mg/dL', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Total Cholesterol <200 mg/dL', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}, {'title': 'Total Cholesterol 200 mg/dL to 240 mg/dL', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}, {'title': 'Total Cholesterol 240 mg/dL to 300 mg/dL', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Total Cholesterol >=300 mg/dL', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'HDL Cholesterol <40 mg/dL', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'HDL Cholesterol 40 mg/dL to <60 mg/dL', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}]}, {'title': 'HDL Cholesterol >=60 mg/dL', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Triglycerides, non-high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, total cholesterol, and HDL cholesterol. Values for all baseline fasting lipid measurements were missing for 8 participants in the ATV/RTV arm. Values for baseline fasting LDL cholesterol were missing for 8 participants in the PI/RTV arm; values for all other baseline lipid measurements were missing for 7 participants.', 'unitOfMeasure': 'participants'}, {'title': 'Human Immunodeficiency Virus Ribonucleic Acid (HIV RNA) Distribution', 'classes': [{'title': '<50 c/mL', 'categories': [{'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}]}]}, {'title': '50 to <400 c/mL', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': '400 to <1000 c/mL', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': '≥1000 c/mL', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Adipose Tissue at Baseline', 'classes': [{'title': 'VAT', 'categories': [{'measurements': [{'value': '131.9', 'groupId': 'BG000', 'lowerLimit': '93.8', 'upperLimit': '185.8'}, {'value': '128.1', 'groupId': 'BG001', 'lowerLimit': '95.8', 'upperLimit': '193.7'}, {'value': '129.4', 'groupId': 'BG002', 'lowerLimit': '94.3', 'upperLimit': '186.1'}]}]}, {'title': 'SAT', 'categories': [{'measurements': [{'value': '209.5', 'groupId': 'BG000', 'lowerLimit': '123.6', 'upperLimit': '300.7'}, {'value': '183.9', 'groupId': 'BG001', 'lowerLimit': '151.4', 'upperLimit': '282.4'}, {'value': '193.6', 'groupId': 'BG002', 'lowerLimit': '140.3', 'upperLimit': '289.2'}]}]}, {'title': 'TAT', 'categories': [{'measurements': [{'value': '356.2', 'groupId': 'BG000', 'lowerLimit': '263.9', 'upperLimit': '446.3'}, {'value': '328.6', 'groupId': 'BG001', 'lowerLimit': '287.3', 'upperLimit': '457.8'}, {'value': '352.0', 'groupId': 'BG002', 'lowerLimit': '268.5', 'upperLimit': '453.1'}]}]}], 'paramType': 'MEDIAN', 'description': 'Visceral, subcutaneous, and total adipose tissue (VAT, SAT, and TAT) as assessed by computed tomography (CT). Values for all 3 measurements were missing for 20 participants in the ATV/RTV arm (n=111). Values for all 3 measurements were missing for 10 participants in the PI/RTV arm (n=59).', 'unitOfMeasure': 'cm2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '25.9', 'groupId': 'BG000', 'lowerLimit': '24.1', 'upperLimit': '28.5'}, {'value': '25.7', 'groupId': 'BG001', 'lowerLimit': '24.2', 'upperLimit': '28.8'}, {'value': '25.9', 'groupId': 'BG002', 'lowerLimit': '24.2', 'upperLimit': '28.5'}]}]}], 'paramType': 'MEDIAN', 'description': '131 participants in ATV/RTV arm and 67 participants in PI/RTV arm had this baseline measurement.', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000', 'lowerLimit': '69', 'upperLimit': '83'}, {'value': '77', 'groupId': 'BG001', 'lowerLimit': '69', 'upperLimit': '87'}, {'value': '76', 'groupId': 'BG002', 'lowerLimit': '69', 'upperLimit': '84'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'CD4 Cell Count', 'classes': [{'categories': [{'measurements': [{'value': '470', 'groupId': 'BG000', 'lowerLimit': '90', 'upperLimit': '1919'}, {'value': '437', 'groupId': 'BG001', 'lowerLimit': '100', 'upperLimit': '1078'}, {'value': '459', 'groupId': 'BG002', 'lowerLimit': '90', 'upperLimit': '1919'}]}]}], 'paramType': 'MEDIAN', 'description': 'CD4 cell=a type of white blood cell that bears the CD4 surface receptor and helps coordinate a range of immune system activities.', 'unitOfMeasure': 'cells/mm3', 'dispersionType': 'FULL_RANGE'}, {'title': 'Trunk Fat, Limb Fat, Total Body Fat', 'classes': [{'title': 'Trunk Fat', 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'BG000', 'lowerLimit': '8.6', 'upperLimit': '15.3'}, {'value': '10.9', 'groupId': 'BG001', 'lowerLimit': '8.8', 'upperLimit': '13.8'}, {'value': '11.4', 'groupId': 'BG002', 'lowerLimit': '8.7', 'upperLimit': '14.6'}]}]}, {'title': 'Limb Fat', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'BG000', 'lowerLimit': '4.6', 'upperLimit': '10.4'}, {'value': '6.7', 'groupId': 'BG001', 'lowerLimit': '4.6', 'upperLimit': '9.4'}, {'value': '7.0', 'groupId': 'BG002', 'lowerLimit': '4.6', 'upperLimit': '10.0'}]}]}, {'title': 'Total Body Fat', 'categories': [{'measurements': [{'value': '20.8', 'groupId': 'BG000', 'lowerLimit': '14.1', 'upperLimit': '26.0'}, {'value': '18.7', 'groupId': 'BG001', 'lowerLimit': '15.6', 'upperLimit': '22.4'}, {'value': '19.8', 'groupId': 'BG002', 'lowerLimit': '14.8', 'upperLimit': '25.7'}]}]}], 'paramType': 'MEDIAN', 'description': 'Values for all 3 baseline fat measurements were missing for 14 participants in the ATV/RTV arm (n=117). Values for baseline trunk fat measurements were missing for 10 participants in the PI/RTV arm (n=59); values for baseline limb fat and total body fat measurements were missing for 13 participants in the PI/RTV arm (n=56).', 'unitOfMeasure': 'kg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Trunk-to-Limb Fat Ratio', 'classes': [{'categories': [{'measurements': [{'value': '1.59', 'groupId': 'BG000', 'lowerLimit': '1.27', 'upperLimit': '2.04'}, {'value': '1.73', 'groupId': 'BG001', 'lowerLimit': '1.17', 'upperLimit': '2.15'}, {'value': '1.62', 'groupId': 'BG002', 'lowerLimit': '1.23', 'upperLimit': '2.10'}]}]}], 'paramType': 'MEDIAN', 'description': '117 participants in ATV/RTV arm and 56 participants in PI/RTV arm had this measure at baseline.', 'unitOfMeasure': 'ratio', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Waist Circumference', 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000', 'lowerLimit': '90', 'upperLimit': '103'}, {'value': '95', 'groupId': 'BG001', 'lowerLimit': '91', 'upperLimit': '100'}, {'value': '94', 'groupId': 'BG002', 'lowerLimit': '90', 'upperLimit': '102'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cm', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Waist-to-Hip Ratio', 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'groupId': 'BG000', 'lowerLimit': '0.95', 'upperLimit': '1.03'}, {'value': '0.97', 'groupId': 'BG001', 'lowerLimit': '0.94', 'upperLimit': '1.02'}, {'value': '0.99', 'groupId': 'BG002', 'lowerLimit': '0.95', 'upperLimit': '1.03'}]}]}], 'paramType': 'MEDIAN', 'description': '131 participants in ATV/RTV arm and 68 participants in PI/RTV arm had this baseline measurement.', 'unitOfMeasure': 'ratio', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 219}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-20', 'studyFirstSubmitDate': '2005-08-25', 'resultsFirstSubmitDate': '2009-12-15', 'studyFirstSubmitQcDate': '2005-08-25', 'lastUpdatePostDateStruct': {'date': '2010-05-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-04-20', 'studyFirstPostDateStruct': {'date': '2005-08-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Trunk-to-limb Fat Ratio as Measured by Dual Energy X-Ray Absortiometry (DEXA) at Week 48', 'timeFrame': 'Baseline, Week 48', 'description': 'Mean changes from Baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values. (Baseline trunk-to-limb fat ratio values can be found in the Baseline Characteristics section.)'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Trunk-to-limb Fat Ratio as Measured by DEXA at Week 96', 'timeFrame': 'Baseline, Week 96', 'description': 'Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values.(Baseline trunk-to-limb fat ratio values can be found in the Baseline Characteristics section.)'}, {'measure': 'Mean Percent Change From Baseline in Visceral Adipose Tissue (VAT) Area by Computed Tomography (CT) Scans and in Trunk Fat by DEXA.', 'timeFrame': 'Baseline, Week 48, Week 96', 'description': 'The mean percent change from baseline in physical signs of lipohypertrophy, as assessed objectively by changes in visceral adipose tissue (VAT) area (cm2) by computed tomography (CT) scans and by changes in trunk fat (kg) by DEXA. Clinical improvement is associated with a decrease in values. (Baseline values can be found in the Baseline Characteristics section.)'}, {'measure': 'Mean Percent Change From Baseline in Peripheral Adipose Tissue (Limb Fat) by DEXA and by Changes in Subcutaneous Adipose Tissue (SAT) Area by CT Scans', 'timeFrame': 'Baseline, Week 48, Week 96', 'description': 'The mean percent change from baseline in physical signs of lipoatrophy, as assessed objectively by changes in peripheral adipose tissue (ie, limb fat (kg) by DEXA and in subcutaneous adipose tissue (SAT) area by CT scans. Clinical improvement is associated with stable values, or an increase in values. (Baseline values can be found in the Baseline Characteristics section.)'}, {'measure': 'Mean Percent Change From Baseline in Total Body Fat by DEXA and in Total Adipose Tissue (TAT) Area by CT Scans', 'timeFrame': 'Baseline, Week 48, Week 96', 'description': 'The mean percent change from baseline in total body fat by DEXA and in total adipose tissue (TAT) area by CT scans. Total body fat and TAT are both associated many factors (trunk fat + limb fat + other \\[weight, etc\\]), and thus clinical improvement cannot be predicted based solely an increase or decrease of these values. (Baseline values can be found in the Baseline Characteristics section.)'}, {'measure': 'Mean Percent Changes From Baseline in Fasting Lipids', 'timeFrame': 'Baseline, Week 48, Week 96', 'description': 'Mean percent changes from baseline in fasting total, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and non-HDL cholesterol, triglycerides, and apolipoprotein B'}, {'measure': 'Mean Changes From Baseline in Fasting Glucose at Week 48 and Week 96', 'timeFrame': 'Baseline, Week 48, Week 96'}, {'measure': 'Mean Changes From Baseline in Fasting Insulin at Week 48 and Week 96', 'timeFrame': 'Baseline, Week 48, Week 96'}, {'measure': 'Mean Changes From Baseline in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)', 'timeFrame': 'Baseline, Week 48, Week 96', 'description': 'HOMA-IR is an index used in evaluation of obese patients at risk for type 2 diabetes which requires fasting glucose and insulin concentrations. It is a mathematical model based on the theory of a negative feedback loop between the liver and β-cells that regulates both fasting glucose and insulin concentrations and can be used to estimate pancreatic β-cell function and degree of insulin resistance. HOMA-IR normal values are between 2 and 2.5. HOMA-IR ≥ 2.5 indicates insulin-resistance.'}, {'measure': 'Mean Changes From Baseline in Body Weight at Week 48 and Week 96', 'timeFrame': 'Baseline, Week 48, Week 96'}, {'measure': 'Mean Changes From Baseline in Waist Circumference at Week 48 and Week 96', 'timeFrame': 'Baseline, Week 48, Week 96'}, {'measure': 'Mean Changes From Baseline in Body Mass Index at Week 48 and Week 96', 'timeFrame': 'Baseline, Week 48, Week 96'}, {'measure': 'Mean Changes From Baseline in Waist-to-Hip Ratio at Week 48 and Week 96', 'timeFrame': 'Baseline, Week 48, Week 96', 'description': 'Mean changes from baseline in proportion of waist to hip measurements.'}, {'measure': 'Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation', 'timeFrame': 'Through Week 96 of study therapy', 'description': 'Percentage of Participants with AEs, Serious AEs (SAEs), Deaths, and AEs leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.'}, {'measure': 'Percentage of Participants With Abnormal Liver Function Tests', 'timeFrame': 'Week 48, Week 96', 'description': 'Percentage of participants with Abnormal Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Total Bilirubin (TBILI) measurements. Values for liver tests are graded using the modified World Health Organization (WHO) criteria. Grade 1 is mild, grade 2 is moderate, grade 3 is severe, grade 4 is life threatening or disabling.'}, {'measure': 'Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation', 'timeFrame': 'Through Week 96', 'description': 'Percentage of Participants with AEs leading to discontinuation of study therapy. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. All events listed in this table were SAEs, except for renal impairment and hypertriglycerideamia, which were an AEs (and did not meet the 5 percent threshold reported in Adverse Event module of this record).'}, {'measure': 'Kaplan-Meier Cumulative Proportion of Participants Without Virologic Rebound (HIV RNA ≥400 c/mL) at Timepoints up to Week 96 in Treated Participants With HIV RNA <400 c/mL at Baseline', 'timeFrame': 'Weeks 8-12, Weeks 20-24, Weeks 32-36, Weeks 44-48, Weeks 56-60, Weeks 68-72, Weeks 80-84, Weeks 92-96', 'description': 'Virologic rebound was measured from the first dose of study therapy to the first of the 2 consecutive measurements ≥400 c/mL. Time to virologic rebound was analyzed using life tables. Measured Values show the Kaplan-Meier cumulative proportion of participants without virologic rebound up to the end of the respective interval.'}, {'measure': 'Mean Change From Baseline in CD4 Count', 'timeFrame': 'Baseline, Week 48, Week 96', 'description': 'Mean change from baseline in CD4 count among treated subjects'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV infections'], 'conditions': ['HIV-Associated Lipodystrophy Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical research study is to learn if human immunodeficiency virus (HIV)-infected subjects with abdominal fat accumulation on their highly active antiretroviral treatment (HAART) regimen have better changes in fat distribution after switching to atazanavir-ritonavir than those remaining on their current protease inhibitor boosted HAART regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-1 infected on HAART regimen containing 2 NRTI and boosted PI for at least 12 weeks prior to screening. Subjects may not have experienced virological failure to more than one prior PI-containing regimen. Must be able to swallow tablets\n* Viral load \\<400 c/mL at screening and stable for at least 6 months\n* Signs of fat redistribution and lipohypertrophy (abdominal) Waist to Hip Ratio \\>0.90 and Waist Circumference \\>88.2 cm for men and Waist Circumference \\>75.3 for women\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* New HIV-related opportunistic infections\n* Active alcohol or substance use\n* Grade 4 lab toxicity\n* History of taking atazanavir (ATV)\n* Prohibited therapies, including non-nucleoside reverse transcriptase inhibitors (NNRTI)'}, 'identificationModule': {'nctId': 'NCT00135356', 'briefTitle': 'Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase IV, Open-Label, Randomized, Multicenter Trial Assessing a Reyataz-Based Substitution Approach in the Management of Lipodystrophy Syndrome. Research Into Atazanavir in Lipodystrophy (The REAL Study)', 'orgStudyIdInfo': {'id': 'AI424-131'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Switch arm', 'interventionNames': ['Drug: Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Arm', 'interventionNames': ['Drug: continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs)']}], 'interventions': [{'name': 'Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs)', 'type': 'DRUG', 'otherNames': ['Reyataz'], 'description': 'Capsules, Oral, ATV 300 mg + RTV 100 mg once daily up to 96 weeks', 'armGroupLabels': ['Switch arm']}, {'name': 'continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs)', 'type': 'DRUG', 'description': 'Protease inhibitor \\[PI\\] combination + 2 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