Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-02-25 @ 6:51 PM
Study NCT ID:
NCT01869634
Status:
COMPLETED
Last Update Posted:
2020-03-04
First Post:
2013-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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': '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': 'D000069454', 'term': 'Darunavir'}, {'id': 'D019438', 'term': 'Ritonavir'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D005663', 'term': 'Furans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dasmuth@UCDAVIS.EDU', 'phone': '916-734-8695', 'title': 'Dr. David Asmuth, Professor of Medicine', 'organization': 'University of California, Davis Health, Department of Internal Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'HIV Positive Naive to ART', 'description': 'HIV subjects will receive open-label darunavir 800 mg in combination with ritonavir 100 mg tablets and fixed-dose combination viread + emtricitabine (Truvada®) to be taken once daily without regard to food. Subjects will undergo upper endoscopy, CT cardiac angiogram, intimal-medial thickening, and peripheral blood collection before and after 12 months of ART.\n\ndarunavir with ritonavir and fixed-dose viread+emtricitabine daily', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Normal Control Volunteers', 'description': 'HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months.', 'otherNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of CD4+ T-cells in the Lamina Propria/mm2 Before and After 12 Months of Therapy Compared to Age-matched Control Volunteers Without HIV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Positive Naive to ART', 'description': 'HIV subjects will receive open-label darunavir 800 mg in combination with ritonavir 100 mg tablets and fixed-dose combination viread + emtricitabine (Truvada®) to be taken once daily without regard to food. Subjects will undergo upper endoscopy, CT cardiac angiogram, intimal-medial thickening, and peripheral blood collection before and after 12 months of ART.\n\ndarunavir with ritonavir and fixed-dose viread+emtricitabine daily'}, {'id': 'OG001', 'title': 'Normal Control Volunteers', 'description': 'HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months.'}], 'classes': [{'title': 'Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '34', 'upperLimit': '190'}, {'value': '478', 'groupId': 'OG001', 'lowerLimit': '389', 'upperLimit': '627'}]}]}, {'title': '12-months after ART', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '213', 'groupId': 'OG000', 'lowerLimit': '120', 'upperLimit': '292'}]}]}], 'analyses': [{'pValue': '0.0025', 'groupIds': ['OG000'], 'groupDescription': 'Comparison between HIV positive naïve to ART before and after ART has been done.', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Wilcoxon signed-rank test. Paired samples.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 12 months', 'description': 'CD4+ T-cells in the lamina propria/mm2 before and after 12 months of therapy compared to age-matched control volunteers without HIV.', 'unitOfMeasure': 'cells / mm^2', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'HIV negative participants underwent the procedures only once at Screening (entry). In the HIV group the comparison between before and after ART was done using a Wilcoxon signed-rank test.'}, {'type': 'SECONDARY', 'title': 'Change in Percentage of Total Artery Diameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Positive Naive to ART', 'description': 'HIV subjects will receive open-label darunavir 800 mg in combination with ritonavir 100 mg tablets and fixed-dose combination viread + emtricitabine (Truvada®) to be taken once daily without regard to food. Subjects will undergo upper endoscopy, CT cardiac angiogram, intimal-medial thickening, and peripheral blood collection before and after 12 months of ART.\n\ndarunavir with ritonavir and fixed-dose viread+emtricitabine daily'}, {'id': 'OG001', 'title': 'Normal Control Volunteers', 'description': 'HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000', 'lowerLimit': '54', 'upperLimit': '61'}, {'value': '53', 'groupId': 'OG001', 'lowerLimit': '50', 'upperLimit': '56'}]}]}], 'analyses': [{'pValue': '0.032', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Two-sample Wilcoxon rank-sum (Mann-Whitney) test'}, {'pValue': '0.826', 'groupIds': ['OG000'], 'groupDescription': 'Comparison of coronary artery wall thickness before and after ART in the HIV infected participants.', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Wilcoxon signed-rank test'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 12 months', 'description': 'computerized axial tomography angiography of the coronary arteries (CT-angio) before and after 12-months of Darunavir therapy', 'unitOfMeasure': '% of total artery diameter', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'We compare wall thickness between HIV+ infected individuals and in the HIV group before and after 12-months of ART.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Systemic Immune Activation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Positive Naive to ART', 'description': 'HIV subjects will receive open-label darunavir 800 mg in combination with ritonavir 100 mg tablets and fixed-dose combination viread + emtricitabine (Truvada®) to be taken once daily without regard to food. Subjects will undergo upper endoscopy, CT cardiac angiogram, intimal-medial thickening, and peripheral blood collection before and after 12 months of ART.\n\ndarunavir with ritonavir and fixed-dose viread+emtricitabine daily'}, {'id': 'OG001', 'title': 'Normal Control Volunteers', 'description': 'HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.74', 'groupId': 'OG000', 'lowerLimit': '1.42', 'upperLimit': '2.15'}, {'value': '0.66', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '0.81'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'comparison between groups (HIV+ vs HIV-)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Two-sample Wilcoxon rank-sum (Mann-Whitney) test'}, {'pValue': '0.807', 'groupIds': ['OG000'], 'groupDescription': 'Changes in systemic immune activation through IL6', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 12 months', 'description': 'Change in systemic immune activation, as measured by change in plasma cytokine levels (IL-6).', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HIV Positive Naive to ART', 'description': 'HIV subjects will receive open-label darunavir 800 mg in combination with ritonavir 100 mg tablets and fixed-dose combination viread + emtricitabine (Truvada®) to be taken once daily without regard to food. Subjects will undergo upper endoscopy, CT cardiac angiogram, intimal-medial thickening, and peripheral blood collection before and after 12 months of ART.\n\ndarunavir with ritonavir and fixed-dose viread+emtricitabine daily'}, {'id': 'FG001', 'title': 'Normal Control Volunteers', 'description': 'HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HIV Positive Naive to ART', 'description': 'HIV subjects will receive open-label darunavir 800 mg in combination with ritonavir 100 mg tablets and fixed-dose combination viread + emtricitabine (Truvada®) to be taken once daily without regard to food. Subjects will undergo upper endoscopy, CT cardiac angiogram, intimal-medial thickening, and peripheral blood collection before and after 12 months of ART.\n\ndarunavir with ritonavir and fixed-dose viread+emtricitabine daily'}, {'id': 'BG001', 'title': 'Normal Control Volunteers', 'description': 'HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000', 'lowerLimit': '31', 'upperLimit': '51'}, {'value': '37', 'groupId': 'BG001', 'lowerLimit': '33', 'upperLimit': '47'}, {'value': '37', 'groupId': 'BG002', 'lowerLimit': '32', 'upperLimit': '50'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'CD4+ T-cells', 'classes': [{'categories': [{'measurements': [{'value': '215', 'groupId': 'BG000', 'lowerLimit': '150', 'upperLimit': '260'}, {'value': '460', 'groupId': 'BG001', 'lowerLimit': '370', 'upperLimit': '530'}, {'value': '310', 'groupId': 'BG002', 'lowerLimit': '210', 'upperLimit': '460'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'HIV viral load', 'classes': [{'categories': [{'measurements': [{'value': '41032', 'groupId': 'BG000', 'lowerLimit': '20689', 'upperLimit': '78805'}, {'value': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '41032', 'groupId': 'BG002', 'lowerLimit': '20689', 'upperLimit': '78805'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'copies/ml', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'weight', 'classes': [{'categories': [{'measurements': [{'value': '187', 'groupId': 'BG000', 'lowerLimit': '153', 'upperLimit': '200'}, {'value': '194', 'groupId': 'BG001', 'lowerLimit': '176', 'upperLimit': '210'}, {'value': '191', 'groupId': 'BG002', 'lowerLimit': '170', 'upperLimit': '210'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'lbs', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-24', 'studyFirstSubmitDate': '2013-06-01', 'resultsFirstSubmitDate': '2018-12-18', 'studyFirstSubmitQcDate': '2013-06-01', 'lastUpdatePostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-24', 'studyFirstPostDateStruct': {'date': '2013-06-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Systemic Immune Activation', 'timeFrame': 'Baseline, 12 months', 'description': 'Change in systemic immune activation, as measured by change in plasma cytokine levels (IL-6).'}], 'primaryOutcomes': [{'measure': 'Number of CD4+ T-cells in the Lamina Propria/mm2 Before and After 12 Months of Therapy Compared to Age-matched Control Volunteers Without HIV', 'timeFrame': 'Baseline, 12 months', 'description': 'CD4+ T-cells in the lamina propria/mm2 before and after 12 months of therapy compared to age-matched control volunteers without HIV.'}], 'secondaryOutcomes': [{'measure': 'Change in Percentage of Total Artery Diameter', 'timeFrame': 'Baseline, 12 months', 'description': 'computerized axial tomography angiography of the coronary arteries (CT-angio) before and after 12-months of Darunavir therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'cardiovascular risk', 'systemic immune activation'], 'conditions': ['Human Immunodeficiency Virus Infection']}, 'descriptionModule': {'briefSummary': 'Potent HIV suppression with Darunavir-based antiretroviral therapy (ART) will lead to repopulation of gastrointestinal-associated lymphoid tissue (GALT) cluster of differentiation (CD)4+ T-cell populations, normalization of systemic immune activation, and improved HIV-associated cardiovascular disease (CVD) risk.', 'detailedDescription': 'Rationale Infection with HIV causes significant morbidity and mortality, even among individuals who are virologically suppressed with combination anti-retroviral therapy (ART). ART is effective in prolonging life and enabling individuals who are HIV positive to live near-normal life spans. However, these individuals are increasingly developing a number of chronic diseases of aging, such as atherosclerotic cardiovascular disease (ASCVD). The proposed studies will examine the role of highly active antiretroviral therapy in restoring the mucosal immunity and the systemic effect on immune activation, bacterial translocation, and change in HIV-associated cardiovascular disease risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing to sign consent form\n* Naïve to ART (remote ART use \\>5 years will be considered on a case by case basis)\n* No known GI or cardiovascular disease\n* Between the ages of 18 and 60\n* No active opportunistic infections or therapy for acute OI within 30 days of entry. Subjects can be on secondary prophylaxis with a history of AIDS defining illness.\n* All women of childbearing potential (WCBP) must have a negative urine pregnancy test before any of the invasive or radiation exposure study procedures.\n* Normal population should be free of chronic metabolic conditions such as diabetes, hypercholesterolemia, or coronary artery disease\n* There are no CD4+ T-cell count or HIV plasma viral load restrictions.\n\nExclusion Criteria:\n\n* Abnormal coagulation parameters (PT\\>1.2 upper limit of normal (ULN))\n* Thrombocytopenia (platelet count \\<50.000 within 6 weeks)\n* Contra-indications to upper endoscopy or conscious sedation\n* Anemia (\\>grade 1 \\[appendix 1\\])\n* Aspirin, ibuprofen, warfarin or other agents that interfere with the coagulation cascade are prohibited within 1 week of endoscopy.\n* Renal insufficiency (serum Creatinine \\>1.2 ULN)\n* History of chronic proteinuria that could impact viread use.\n* Allergy to contrast used for CT angiography\n* Requirement to take medications that are contraindicated with study ART regimen.'}, 'identificationModule': {'nctId': 'NCT01869634', 'briefTitle': 'Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART', 'orgStudyIdInfo': {'id': '394080'}, 'secondaryIdInfos': [{'id': 'IIS RFA _Asmuth:TMC114HIV2029', 'type': 'OTHER', 'domain': 'Other'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HIV positive naive to ART', 'description': 'HIV subjects will receive open-label darunavir 800 mg in combination with ritonavir 100 mg tablets and fixed-dose combination viread + emtricitabine (Truvada®) to be taken once daily without regard to food. Subjects will undergo upper endoscopy, CT cardiac angiogram, intimal-medial thickening, and peripheral blood collection before and after 12 months of ART.', 'interventionNames': ['Drug: darunavir with ritonavir and fixed-dose viread+emtricitabine daily']}, {'type': 'NO_INTERVENTION', 'label': 'normal control volunteers', 'description': 'HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months.'}], 'interventions': [{'name': 'darunavir with ritonavir and fixed-dose viread+emtricitabine daily', 'type': 'DRUG', 'otherNames': ['darunavir (Prezista®) 800 mg with ritonavir 100 mg and Truvada® to be taken once daily'], 'armGroupLabels': ['HIV positive naive to ART']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95617', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}