Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2026-04-16 @ 4:51 PM
Study NCT ID:
NCT01535235
Status:
COMPLETED
Last Update Posted:
2016-06-16
First Post:
2012-02-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ACE Inhibitors to Decrease Lymphoid Fibrosis in Antiretroviral-Treated, HIV-infected Patients: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017706', 'term': 'Lisinopril'}], 'ancestors': [{'id': 'D004151', 'term': 'Dipeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lcockerham@mcw.edu', 'phone': '414-805-0738', 'title': 'Dr. Leslie Cockerham', 'organization': 'Medical College of Wisconsin'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'ACE Inhibitor', 'description': 'Active group\n\nLisinopril: Lisinopril 20mg QD x 24 weeks', 'otherNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo group\n\nPlacebo: Placebo QD x24wks', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Elevation in serum creatinine', 'notes': 'One subject had elevation of serum creatinine and was withdrawn from the study at Week 12 for this. However, labs drawn at that time showed that the serum creatinine had returned to baseline and was likely secondary to another medical condition.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in HIV RNA (Copies/Million Rectal Cells)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACE Inhibitor', 'description': 'Active group\n\nLisinopril: Lisinopril 20mg QD x 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo group\n\nPlacebo: Placebo QD x24wks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '-74.5', 'upperLimit': '62.5'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-55.8', 'upperLimit': '96.4'}]}]}], 'analyses': [{'pValue': '0.63', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '22 weeks', 'description': 'Change in HIV RNA measured in GALT (gut-associated lymphoid tissue) from baseline', 'unitOfMeasure': 'copies/million rectal cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Three participants in the placebo group did not have sufficient cells for analysis for one of the time points.'}, {'type': 'SECONDARY', 'title': 'Change in HIV DNA (Copies/Million Rectal Cells)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACE Inhibitor', 'description': 'Active group\n\nLisinopril: Lisinopril 20mg QD x 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo group\n\nPlacebo: Placebo QD x24wks'}], 'classes': [{'categories': [{'measurements': [{'value': '-38.4', 'groupId': 'OG000', 'lowerLimit': '-76.3', 'upperLimit': '114.8'}, {'value': '-53.8', 'groupId': 'OG001', 'lowerLimit': '-102.9', 'upperLimit': '87.3'}]}]}], 'analyses': [{'pValue': '0.63', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '22 weeks', 'description': 'Change in HIV DNA measured in GALT (gut-associated lymphoid tissue) from baseline', 'unitOfMeasure': 'copies/million rectal cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Three participants in the placebo group did not have sufficient cells for analysis for one of the time points.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ACE Inhibitor', 'description': 'Active group\n\nLisinopril: Lisinopril 20mg QD x 24 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo group\n\nPlacebo: Placebo QD x24wks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'The trial over enrolled by one individual as one participant discontinued the study after enrollment due to an adverse event.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ACE Inhibitor', 'description': 'Active group\n\nLisinopril: Lisinopril 20mg Daily x 24 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo group\n\nPlacebo: Placebo Daily x24wks'}, {'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': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', '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': '53', 'groupId': 'BG000', 'lowerLimit': '45.5', 'upperLimit': '56'}, {'value': '54', 'groupId': 'BG001', 'lowerLimit': '47', 'upperLimit': '58'}, {'value': '54', 'groupId': 'BG002', 'lowerLimit': '47', 'upperLimit': '57'}]}]}], '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': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'CD4+ T cell count', 'classes': [{'categories': [{'measurements': [{'value': '349', 'groupId': 'BG000', 'lowerLimit': '230', 'upperLimit': '415'}, {'value': '392', 'groupId': 'BG001', 'lowerLimit': '237', 'upperLimit': '641'}, {'value': '362', 'groupId': 'BG002', 'lowerLimit': '237', 'upperLimit': '636'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-12', 'studyFirstSubmitDate': '2012-02-09', 'resultsFirstSubmitDate': '2016-03-01', 'studyFirstSubmitQcDate': '2012-02-14', 'lastUpdatePostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-01', 'studyFirstPostDateStruct': {'date': '2012-02-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HIV RNA (Copies/Million Rectal Cells)', 'timeFrame': '22 weeks', 'description': 'Change in HIV RNA measured in GALT (gut-associated lymphoid tissue) from baseline'}], 'secondaryOutcomes': [{'measure': 'Change in HIV DNA (Copies/Million Rectal Cells)', 'timeFrame': '22 weeks', 'description': 'Change in HIV DNA measured in GALT (gut-associated lymphoid tissue) from baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'Lymphoid fibrosis'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'The investigators propose a proof-of-concept, pathogenesis-oriented, randomized, placebo-controlled pilot study to assess whether the addition of an angiotensin converting enzyme (ACE) inhibitor to standard Highly Active Antiretroviral Therapy (HAART) reverses lymphoid fibrosis, and whether this leads to more effective HIV-specific host immune responses and an accelerated clearance of the latent reservoir.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria include:\n\n* Stable HAART with maintenance of plasma HIV RNA levels below level of detection (\\< 40-75 copies/mL) for ≥ 12 months\n* \\> 90% adherence to HAART within preceding 30 days\n\nExclusion Criteria include:\n\n* Screening systolic blood pressure \\< 110mm Hg or diastolic blood pressure \\< 60mm Hg\n* Current use of any ACE inhibitor, angiotensin receptor blocker, or aldosterone antagonist\n* Known diabetes mellitus or cardiovascular/kidney/collagen vascular disease\n* Pregnant/breastfeeding women.'}, 'identificationModule': {'nctId': 'NCT01535235', 'briefTitle': 'ACE Inhibitors to Decrease Lymphoid Fibrosis in Antiretroviral-Treated, HIV-infected Patients: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'ACE Inhibitors to Decrease Lymphoid Fibrosis in Antiretroviral-Treated, HIV-infected Patients: A Pilot Study', 'orgStudyIdInfo': {'id': '11-08132'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ACE Inhibitor', 'description': 'Active group', 'interventionNames': ['Drug: Lisinopril']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo group', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lisinopril', 'type': 'DRUG', 'description': 'Lisinopril 20mg QD x 24 weeks', 'armGroupLabels': ['ACE Inhibitor']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo QD x24wks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco General Hospital', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Hiroyu Hatano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'amfAR, The Foundation for AIDS Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}