Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT01023620
Status:
COMPLETED
Last Update Posted:
2019-10-08
First Post:
2009-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
HIV Acquired Lipodystrophy (HAL) Classification, Measurement and Fat Response to Thiazolidinedione (TZD) (Pioglitazone)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D008060', 'term': 'Lipodystrophy'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], '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'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077205', 'term': 'Pioglitazone'}, {'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Michael.Limerick@UTSouthwestern.edu', 'phone': '214-590-0611', 'title': 'Dr. Michael Limerick', 'organization': 'UT Southwestern Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'No data are available for this study as the PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed', 'description': 'No data are available for this study as the PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed', 'eventGroups': [{'id': 'EG000', 'title': 'Pioglitazone', 'description': '10 male patients with lipodystrophy taking daily Pioglitazone 45 mg\n\nPioglitazone: Participants will take oral Pioglitazone 45 mg daily for 16 weeks.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Observation/Comparison', 'description': '10 male patients with lipodystrophy not taking daily Pioglitazone\n\nObservation: Participants will be observed for 16 weeks but will not receive drug', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Liver Fat Pre/Post Challenge With Daily Pioglitazone 45 mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone', 'description': '10 male patients with lipodystrophy taking daily Pioglitazone 45 mg\n\nPioglitazone: Participants will take oral Pioglitazone 45 mg daily for 16 weeks.'}, {'id': 'OG001', 'title': 'Observation/Comparison', 'description': '10 male patients with lipodystrophy not taking daily Pioglitazone\n\nObservation: Participants will be observed for 16 weeks but will not receive drug'}], 'timeFrame': '16 weeks', 'description': 'No data are available for this study as the PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed', 'reportingStatus': 'POSTED', 'populationDescription': 'No data are available for this study as the PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed'}, {'type': 'SECONDARY', 'title': 'Fine Needle Aspiration of Fat Pre/Post With Daily Pioglitazone 45 mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone', 'description': '10 male patients with lipodystrophy taking daily Pioglitazone 45 mg\n\nPioglitazone: Participants will take oral Pioglitazone 45 mg daily for 16 weeks.'}, {'id': 'OG001', 'title': 'Observation/Comparison', 'description': '10 male patients with lipodystrophy not taking daily Pioglitazone\n\nObservation: Participants will be observed for 16 weeks but will not receive drug'}], 'timeFrame': '16 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Investigator left the university mid way through the study and unable to find him.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pioglitazone', 'description': '10 male patients with lipodystrophy taking daily Pioglitazone 45 mg\n\nPioglitazone: Participants will take oral Pioglitazone 45 mg daily for 16 weeks.'}, {'id': 'FG001', 'title': 'Observation/Comparison', 'description': '10 male patients with lipodystrophy not taking daily Pioglitazone\n\nObservation: Participants will be observed for 16 weeks but will not receive drug'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'No data are available for this study as the PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pioglitazone', 'description': '10 male patients with lipodystrophy taking daily Pioglitazone 45 mg\n\nPioglitazone: Participants will take oral Pioglitazone 45 mg daily for 16 weeks.'}, {'id': 'BG001', 'title': 'Observation/Comparison', 'description': '10 male patients with lipodystrophy not taking daily Pioglitazone\n\nObservation: Participants will be observed for 16 weeks but will not receive drug'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}]}, {'title': 'Age, Continuous'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}]}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States'}], 'unitOfMeasure': 'participants'}, {'title': '0 Participants'}], 'populationDescription': 'No data are available for this study as the PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2010-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-16', 'studyFirstSubmitDate': '2009-11-30', 'resultsFirstSubmitDate': '2019-03-08', 'studyFirstSubmitQcDate': '2009-12-01', 'lastUpdatePostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-16', 'studyFirstPostDateStruct': {'date': '2009-12-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Liver Fat Pre/Post Challenge With Daily Pioglitazone 45 mg', 'timeFrame': '16 weeks', 'description': 'No data are available for this study as the PI has left the institution. Multiple efforts to contact the PI for the relevant data have failed'}], 'secondaryOutcomes': [{'measure': 'Fine Needle Aspiration of Fat Pre/Post With Daily Pioglitazone 45 mg', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'Lipodystrophy', 'Lipoatrophy', 'Lipohypertrophy', 'Human Immunodeficiency Virus'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': "This study is being done to better understand why people with HIV who have taken drugs for HIV begin to show abnormal changes in fat loss or fat gain in their bodies. This condition is called lipodystrophy.\n\nPatients who take medicine for HIV and who have lipodystrophy report loss of subcutaneous (sc) fat from the arms, legs, and face and excess fat gain in the neck and truncal region. They also more likely to have problems with insulin in the body, high fat levels in the blood and diabetes. The reason that lipodystrophy develops is not fully understood although some HIV drugs have are very likely the cause. The complications pose an increased risk of fat blockage forming in the arteries making you more at risk for heart problems in the future. Changes in body fat can cause physical discomfort and psychological distress. Management of these problems can be a challenge for the patient's doctor.\n\nThe investigators propose data collection to determine if there is more than one reason why this might happen in some people and not in others. Laboratory samples being collected: 1) special imaging of the liver; 2) fat collected by needle from the mid thigh and mid-shoulder areas; 3) blood samples to measure the virus, t-cells, fats, and other markers of how the patient's body is handling the virus.\n\nThis study is being done because science does not fully understand why some patients with HIV who take medicines for the virus have abnormal fat loss or gain and some do not. This research study is intended to help us better understand why and how this happens."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Biological Male', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants must be 18 years of age or older of all racial and ethnic origins, and capable of giving informed consent. Spanish speaking individuals are eligible for participation.\n\nAdditionally they must be/have:\n\n1. Biologically male (not transgendered)\n2. HIV positive for at least 24 months,\n3. On stable HAART for at least the last 3 months prior to entering the study,\n4. Practitioner diagnosed lipodystrophy as defined by:\n\naHAL (any of these) decreased subcutaneous fat in the limbs with prominent veins, loss of buttock fat or facial atrophy hHAL: fat accumulation in abdomen and/or dorsocervical region\n\nExclusion Criteria:\n\nParticipants cannot be less than 18 years of age, institutionalized, nor have prior diseases or conditions that may alter body fat composition. Exclusions:\n\n1. Females are excluded\n2. Prior history of CHF\n3. Prior history of macular retinal edema\n4. Prior history of spontaneous bone fracture\n5. Diabetics receiving oral/injected/inhaled diabetic agents or individuals with a fasting blood glucose value greater than or equal to 140 within the last 90 days.\n6. Current active opportunistic infections for example :\n\n 1. PCP pneumonia\n 2. Neuropathy\n 3. Thrush\n 4. Systemic KS (Kaposi sarcoma)\n\n i) localized cutaneous lesions are not an exclusion e) MAC (Mycobacterium Avium complex) f) Histoplasmosis g) Coccidioidomycosis\n7. Planning to discontinue HAART\n8. Current diagnosis of cancer or receiving chemotherapy\n9. Systemic steroid use during the prior 6 months\n10. Hepatitis C+ or previous diagnosis of cirrhosis\n11. Liver Function Studies great than or equal to triple of normal values'}, 'identificationModule': {'nctId': 'NCT01023620', 'acronym': 'HAL', 'briefTitle': 'HIV Acquired Lipodystrophy (HAL) Classification, Measurement and Fat Response to Thiazolidinedione (TZD) (Pioglitazone)', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Human Immunodeficiency Virus Acquired Lipodystrophy (HAL) Classification, Measurement, & Fat Response to a Thiazolidinedione (TZD) Challenge in Differing Adult Phenotypic Presentations', 'orgStudyIdInfo': {'id': 'Takeda IISR - MSA-PIO-028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pioglitazone', 'description': '10 male patients with lipodystrophy taking daily Pioglitazone 45 mg', 'interventionNames': ['Drug: Pioglitazone']}, {'type': 'SHAM_COMPARATOR', 'label': 'Observation/Comparison', 'description': '10 male patients with lipodystrophy not taking daily Pioglitazone', 'interventionNames': ['Other: Observation']}], 'interventions': [{'name': 'Pioglitazone', 'type': 'DRUG', 'otherNames': ['Actos'], 'description': 'Participants will take oral Pioglitazone 45 mg daily for 16 weeks.', 'armGroupLabels': ['Pioglitazone']}, {'name': 'Observation', 'type': 'OTHER', 'otherNames': ['Comparison'], 'description': 'Participants will be observed for 16 weeks but will not receive drug', 'armGroupLabels': ['Observation/Comparison']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390-9173', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center at Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Nancy Rollins, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UT Southwestern Medical Center at Dallas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Takeda Pharmaceuticals North America, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}