Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-31 @ 9:14 AM
Study NCT ID:
NCT01579695
Status:
TERMINATED
Last Update Posted:
2018-09-11
First Post:
2012-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Observational Study in HIV Subjects Exposed to EGRIFTA®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C479538', 'term': 'tesamorelin'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 391}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-10', 'studyFirstSubmitDate': '2012-04-12', 'studyFirstSubmitQcDate': '2012-04-16', 'lastUpdatePostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to development of malignancies in HIV-infected subjects with abdominal lipohypertrophy exposed to EGRIFTA® vs. concurrent, comparable control group not exposed to EGRIFTA®', 'timeFrame': '10 years'}], 'secondaryOutcomes': [{'measure': 'Time to development or worsening of Type 2 Diabetes Mellitus, diabetic retinopathy, hypersensitivity reactions, hepatic and renal function, adverse events and major adverse cardiovascular events', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV with lipohypertrophy'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'The purpose of this observational, 10-year, prospective cohort study is to assess the potential safety concerns of long-term exposure to EGRIFTA® in HIV-infected subjects with abdominal lipohypertrophy compared with a similar group of subjects not exposed to EGRIFTA®.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study population will be representative of the HIV-injected population affected by abdominal lipohypertrophy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll of the following inclusion criteria must be fulfilled:\n\n1. Subject has given written informed consent;\n2. Subject is an adult man or woman ≥ 18 years old;\n3. Subject has HIV infection;\n4. Subject has physical evidence of excess abdominal fat, as determined by the examining study physician.\n5. Subject has completed standard of care assessments (mammography, cervical PAP smear, colonoscopy and blood work for HIV-1 RNA, CD4 cell count, renal, hepatic, and hematology, PSA test, fasting blood glucose, lipid panel ) prior to being enrolled onto the study.\n\nExclusion Criteria:\n\nExclusion criteria 1 through 4 are based on the contraindications for EGRIFTA®.\n\n1. Disruption of the hypothalamic-pituitary axis, including conditions such as hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation, or head trauma;\n2. Active malignancy (newly diagnosed or recurrent)\n3. Known hypersensitivity to tesamorelin and/or mannitol\n4. Pregnancy or lactation\n5. Use of EGRIFTA® within 6 months prior to baseline\n6. Failure to complete any standard of care assessments listed in Section 5.2.1'}, 'identificationModule': {'nctId': 'NCT01579695', 'briefTitle': 'Long-term Observational Study in HIV Subjects Exposed to EGRIFTA®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Theratechnologies'}, 'officialTitle': 'A Phase 4, Observational, Multicenter, 10-year Prospective Cohort Safety Study Comparing Subjects With HIV-associated Abdominal Lipohypertrophy Exposed to EGRIFTA® (Tesamorelin for Injection) to a Similar Group of Subjects Not Exposed to EGRIFTA®', 'orgStudyIdInfo': {'id': 'EMR200147-501'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exposed Group will receive Tesamorelin', 'interventionNames': ['Drug: Tesamorelin for injection']}, {'label': 'Control Group will not receive Tesamorelin'}], 'interventions': [{'name': 'Tesamorelin for injection', 'type': 'DRUG', 'description': 'Daily 2 mg subcutaneous injections of Tesamorelin', 'armGroupLabels': ['Exposed Group will receive Tesamorelin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93301', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Franco Felizarta, MD', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Coast Medical Group', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90035', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California CARE Clinic, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Tower Infectious Diseases Medical Associates', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Oasis Clinic', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'VAMC, Infectious Disease Section 111W', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20009', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Dupont Circle Physician's Group", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20036', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Capital Medical Associates, PC', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Gary J. Richmond, M.D., PA', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33133', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'The Kinder Medical Group-AHF', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32805', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orange County Health Department', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orange County Health Department', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33305', 'city': 'Wilton Manors', 'state': 'Florida', 'country': 'United States', 'facility': 'Rowan Tree Medical, P.A.', 'geoPoint': {'lat': 26.16036, 'lon': -80.13893}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Absolute Care Medical Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60657', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northstar Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62702', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Southern Illnois University School of Medicine', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01105', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'The Researth Institute', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '48072-3436', 'city': 'Berkley', 'state': 'Michigan', 'country': 'United States', 'facility': 'Be Well Medical Center, P.C', 'geoPoint': {'lat': 42.50309, 'lon': -83.18354}}, {'zip': '63108', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Southhampton Clinical Research, Inc. d.b.a. Central West Clinical Research', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63139', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Southampton Healthcare, Inc.', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08244', 'city': 'Somers Point', 'state': 'New Jersey', 'country': 'United States', 'facility': 'South Jersey Unfectious Disease', 'geoPoint': {'lat': 39.31762, 'lon': -74.5946}}, {'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'University at Buffalo, State University of NY, Erie County Medical Center', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Ricky K. Hsu, MD, PC', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44304', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Summa Health Care System', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '74127', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Virginia Mason Medical Center', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '19611', 'city': 'West Reading', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Reading Hospital and Medical Center', 'geoPoint': {'lat': 40.3337, 'lon': -75.94743}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'facility': 'St. Hope Foundation, Inc.', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas VA Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center at Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '98112', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Virginia Mason Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Jean-Claude Mamputu, PhD', 'affiliation': 'Theratechnologies Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Theratechnologies', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}