Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-31 @ 8:34 PM
Study NCT ID:
NCT01776151
Status:
COMPLETED
Last Update Posted:
2023-03-21
First Post:
2012-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arterial Elasticity: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Citrated plasma is collected at each study visit and stored at a central lab for future assessment of changes in plasma markers of thrombosis and fibrinolysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 337}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-19', 'studyFirstSubmitDate': '2012-09-18', 'studyFirstSubmitQcDate': '2013-01-22', 'lastUpdatePostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in large artery elasticity (LAE', 'timeFrame': 'baseline, Months 1, 4, 8, 12, annually thereafter', 'description': 'Large artery elasticity is measured using a tonometer placed on the forearm.'}, {'measure': 'Change from baseline in small artery elasticity (SAE)', 'timeFrame': 'baseline, Months 1, 4, 8, 12, annually thereafter', 'description': 'Small artery elasticity is measured using a tonometer placed on the forearm.'}], 'secondaryOutcomes': [{'measure': 'Changes in plasma markers of thrombosis and fibrinolysis', 'timeFrame': 'baseline, months 4, 8, 12, annually thereafter', 'description': 'Citrated plasma will be collected and stored for central measurement of plasma markers of thrombosis and fibrinolysis in the future.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'cardiovascular diseases', 'vascular stiffness'], 'conditions': ['Cardiovascular Diseases', 'HIV']}, 'referencesModule': {'references': [{'pmid': '25711329', 'type': 'DERIVED', 'citation': 'Baker JV, Engen NW, Huppler Hullsiek K, Stephan C, Jain MK, Munderi P, Pett S, Duprez D; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Assessment of arterial elasticity among HIV-positive participants with high CD4 cell counts: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 1):109-18. doi: 10.1111/hiv.12239.'}], 'seeAlsoLinks': [{'url': 'http://www.insight-trials.org', 'label': 'INSIGHT network website, including information on the START Arterial Elasticity Substudy'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to find out if starting anti-retroviral therapy (ART) above 500 cluster-of-differentiation-4 (CD4)+ cells/milliliter (mL) ('early ART group') is better at reducing the stiffness of arteries than waiting to start ART until the CD4+ drops below 350 cells/mL ('deferred ART group'). Artery stiffness has been associated with an increased risk of cardiovascular (heart) disease, and could be useful as an earlier indicator of heart disease. In this study, the stiffness of arteries will be measured at study entry, months 4, 8, 12, and annually thereafter, using a tonometer on the participant's forearm."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Enrollees are HIV-positive, antiretroviral-naive individuals with CD4+ \\> 500 cells/mL randomized to the START trial.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Simultaneous co-enrollment in the START study\n* Signed informed consent\n\nExclusion Criteria:\n\n* Inability to ascertain waveform measurements that can be analyzed, i.e. atrial fibrillation'}, 'identificationModule': {'nctId': 'NCT01776151', 'briefTitle': 'Arterial Elasticity: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Arterial Elasticity: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)', 'orgStudyIdInfo': {'id': '0603M83587-3'}}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'overallOfficials': [{'name': 'Jason V Baker, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Minnesota'}, {'name': 'Daniel Duprez, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}