Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2025-12-29 @ 12:16 AM
Study NCT ID:
NCT00433992
Status:
COMPLETED
Last Update Posted:
2017-09-05
First Post:
2007-02-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Metabolic Effects of Non-Thymidine Analogue Anti-HIV Medications
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D008060', 'term': 'Lipodystrophy'}], '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': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mccomsey.grace@clevelandactu.org', 'phone': '216-844-2739', 'title': 'Dr. Grace McComsey', 'organization': 'Case Western Reserve University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Limitations included small sample size and premature study discontinuation before week 96'}}, 'adverseEventsModule': {'timeFrame': 'the adverse event data was collected over the duration of the study of 96 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'ABC/3TC', 'description': 'HIV-infected subjects taking abacavir-lamivudine (ABC/3TC)', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'TDF/FTC', 'description': 'HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir-lamivudine (ATV-r)', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Mitochondrial Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ABC/3TC+EFV', 'description': 'HIV-infected subjects taking abacavir-lamivudine (ABC/3TC) with Efavirenz at baseline'}, {'id': 'OG001', 'title': 'TDF/FTC+EFV', 'description': 'HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with Efavirenz at baseline'}, {'id': 'OG002', 'title': 'ATV/r +TDF/FTC', 'description': 'HIV infected subjects taking atazanavir-ritonavir with tenofovir DF-emtricitabine at baseline'}, {'id': 'OG003', 'title': 'ATV/r +ABC/3TC', 'description': 'HIV-infected subjects taking atazanavir-ritonavir with abacavir-lamivudine at baseline'}], 'classes': [{'categories': [{'measurements': [{'value': '1250', 'groupId': 'OG000', 'lowerLimit': '998', 'upperLimit': '1886'}, {'value': '1312', 'groupId': 'OG001', 'lowerLimit': '920', 'upperLimit': '1609'}, {'value': '1150', 'groupId': 'OG002', 'lowerLimit': '721', 'upperLimit': '1423'}, {'value': '1125', 'groupId': 'OG003', 'lowerLimit': '1049', 'upperLimit': '1588'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Entry, Week 96', 'description': 'mtDNA content in adipose tissue was measured by quantitative real-time polymerase chain-reaction.', 'unitOfMeasure': 'copies/cell', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Fat Apoptosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABC/3TC', 'description': 'HIV-infected subjects taking abacavir-lamivudine (ABC/3TC)'}, {'id': 'OG001', 'title': 'TDF/FTC', 'description': 'HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir-lamivudine (ATV-r)'}], 'classes': [{'categories': [{'measurements': [{'value': '906', 'groupId': 'OG000', 'lowerLimit': '-349', 'upperLimit': '1900'}, {'value': '1479', 'groupId': 'OG001', 'lowerLimit': '353', 'upperLimit': '3032'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Entry, Week 48', 'description': 'Changes in limb fat from 0 to 48 weeks measured with whole-body dual-energy x-ray absorptiometry', 'unitOfMeasure': 'g', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ABC/3TC', 'description': 'HIV-infected subjects taking abacavir-lamivudine (ABC/3TC)'}, {'id': 'FG001', 'title': 'TDF/FTC', 'description': 'HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir-lamivudine (ATV-r)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ABC/3TC', 'description': 'HIV-infected subjects taking abacavir-lamivudine (ABC/3TC)'}, {'id': 'BG001', 'title': 'TDF/FTC', 'description': 'HIV-infected subjects taking tenofovir DF-emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir-lamivudine (ATV-r)'}, {'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': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', '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': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood collection'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-01', 'studyFirstSubmitDate': '2007-02-09', 'resultsFirstSubmitDate': '2017-03-28', 'studyFirstSubmitQcDate': '2007-02-09', 'lastUpdatePostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-16', 'studyFirstPostDateStruct': {'date': '2007-02-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mitochondrial Activity', 'timeFrame': 'Entry, Week 96', 'description': 'mtDNA content in adipose tissue was measured by quantitative real-time polymerase chain-reaction.'}], 'secondaryOutcomes': [{'measure': 'Change in Fat Apoptosis', 'timeFrame': 'Entry, Week 48', 'description': 'Changes in limb fat from 0 to 48 weeks measured with whole-body dual-energy x-ray absorptiometry'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mitochondria', 'Fat apoptosis', 'Lipoatrophy', 'Lipodystrophy', 'Thymidine', 'Treatment experienced'], 'conditions': ['HIV Infections']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.clinicaltrials.gov/ct/show/NCT00118898', 'label': 'Click here for more information on ACTG A5202 and ACTG 5224'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to observe the effects of certain anti-HIV medications on mitochondrial activity and fat cell death. This study will enroll participants from another study, ACTG A5202, who are on treatment regimens that do not include zidovudine, stavudine, or other thymidine-containing anti-HIV medications.', 'detailedDescription': 'The main objective of this study is to observe the effects of anti-HIV medication lacking thymidine on mitochondrial metabolism and adipocyte apoptosis (fat cell death). Changes in mitochondrial metabolism and increases in adipocyte apoptosis are associated with lipoatrophy. Lipoatrophy is a common condition characterized by loss of subcutaneous fat and can be caused by many anti-HIV medications. This study will examine the metabolic consequences of the use of thymidine analogue-sparing treatment regimens.\n\nThis study will evaluate HIV infected patients who are enrolled in ACTG A5202, starting their first nucleoside reverse transcriptase inhibitor (NRTI)-containing regimen. This regimen will include either tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) or abacavir/lamivudine (ABC/3TC), which are thymidine-sparing regimens. The changes in mitochondrial activity and fat cell death will be compared between participants taking thymidine-sparing regimens (TDF/FTC or ABC/3TC) and thymidine-containing regimens.\n\nThis study will last for 96 weeks, with two study visits occurring at entry and another visit at Week 96. During each visit, a dual energy x-ray absorptiometry (DEXA) scan and blood collection will occur, and a fat biopsy will be performed in the lower abdomen under local anesthetic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV-infected patients who are enrolled in ACTG A5202, starting their first nucleoside reverse transcriptase inhibitor (NRTI)-containing regimen', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-infected\n* Enrolling in ACTG A5202 and its metabolic substudy ACTG A5224\n\nExclusion Criteria:\n\n* Bleeding problems\n* Cannot undergo fat biopsies\n* Require aspirin anytime in the 7-day period prior to each biopsy'}, 'identificationModule': {'nctId': 'NCT00433992', 'briefTitle': 'Metabolic Effects of Non-Thymidine Analogue Anti-HIV Medications', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Effects of Thymidine Sparing Regimens on Mitochondrial Metabolism and Adipocyte Apoptosis', 'orgStudyIdInfo': {'id': '1R01AI065348-01A2', 'link': 'https://reporter.nih.gov/quickSearch/1R01AI065348-01A2', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ABC/3TC', 'description': 'HIV-infected subjects were given Abacavir-Lamuvidine'}, {'label': 'TDF/FTC', 'description': 'HIV-infected patients were given tenofovir DF-emtricitabine'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case School of Medicine', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Grace McComsey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Grace McComsey, MD, Case School of Medicine', 'investigatorFullName': 'Grace McComsey', 'investigatorAffiliation': 'National Institute of Allergy and Infectious Diseases (NIAID)'}}}}