Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-02-25 @ 7:03 PM
Study NCT ID:
NCT01850212
Status:
COMPLETED
Last Update Posted:
2014-10-31
First Post:
2013-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 476}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-30', 'studyFirstSubmitDate': '2013-03-28', 'studyFirstSubmitQcDate': '2013-05-07', 'lastUpdatePostDateStruct': {'date': '2014-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Femoral Neck and Spine (L1-4) T-score', 'timeFrame': 'Day 1', 'description': 'Femoral neck and spine (L1-4) T-score will be used to characterize the profile of low bone mineral density (BMD) in ≥ 50 year old male subjects and post-menopausal female subjects on any tenofovir disoproxil fumarate (TDF)-based regimen relative to those on any non-TDF-based regimen for HIV infection.'}], 'secondaryOutcomes': [{'measure': 'Observed T-score < -2 (yes/no) for femoral neck and spine (L1-4)', 'timeFrame': 'Day 1', 'description': 'Observed T-score for femoral neck and spine will be used to further characterize low BMD.'}, {'measure': 'Observed -2 ≤ T-score < -1 (yes/no) for femoral neck and spine (L1-4)', 'timeFrame': 'Day 1', 'description': 'Observed T-score for femoral neck and spine will be used to further characterize low BMD.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Treatment Experienced', 'Male greater than or equal to 50 years', 'Female postmenopausal'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'A Phase 4 study is to characterize the profile of low bone mineral density (BMD) in ≥ 50 year old male subjects and post-menopausal female subjects on any tenofovir disoproxil fumarate (TDF)-based regimen'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study population of ≥ 50 year old male subjects and post-menopausal female subjects', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.\n* HIV-1 infected subjects regardless of race or ethnicity\n* Use of one of the following taken as a stable, continuous, NRTI-containing antiretroviral (ARV) regimen for ≥ 3 years are allowed (within-class change of agents other than TDF within 3 years of study entry are permitted as specified):\n\n * TDF plus PI/r-containing regimen including subjects who switched from one TDF plus PI/r regimen to another TDF plus PI/r regimen\n * a TDF plus non-PI/r-containing regimen including subjects who switched from one TDF plus non-PI/r regimen to another TDF plus non-PI/r regimen\n * a Non-TDF NRTI plus a PI/r-containing regimen including subjects who switched from one non-TDF NRTI plus PI/r regimen to another non-TDF NRTI regimen plus PI/r regimen\n * a Non-TDF NRTI plus a non-PI/r-containing regimen including subjects who switched from one non-TDF NRTI plus non-PI/r regimen to another non-TDF NRTI regimen plus non-PI/r regimen\n* Of note, subjects in the non-TDF groups must have never taken a regimen that includes TDF (including previous exposure to TDF for pre-exposure prophylaxis (PrEP))\n* Subjects included in the TDF groups must have always taken a regimen that includes TDF. Non-PI/r agents include non-nucleoside reverse transcriptase inhibitors (NNRTIs), integrase inhibitors, triple nucleoside inhibitors and non-boosted protease inhibitors\n* Male subjects must be ≥ 50 years of age\n* Female subjects must be postmenopausal. Menopause can be assumed to have occurred in a woman when there is either appropriate medical documentation of prior complete bilateral oophorectomy or permanent cessation of previously occurring menses \\> 12 months as a result of ovarian failure or bilateral oophorectomy with documentation of hormonal deficiency by a certified healthcare provided\n* Adequate records available to evaluate medical history for the 3 years prior to study entry\n\nExclusion Criteria:\n\n* Subject has a contraindication to dual-energy X-ray absorptiometry (DEXA) scans\n* Subject has a history of osteoporosis before initiating Highly Active Antiretroviral Treatment (HAART)'}, 'identificationModule': {'nctId': 'NCT01850212', 'briefTitle': 'A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects', 'orgStudyIdInfo': {'id': 'GS-US-104-0423'}, 'secondaryIdInfos': [{'id': '2011-004420-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Male (≥ 50 years), TDF', 'description': 'Male (≥ 50 years of age) on regimens containing tenofovir disoproxil fumarate (TDF)'}, {'label': 'Male (≥ 50 years of age), Non-TDF', 'description': 'Male (≥ 50 years of age) on non-TDF (tenofovir disoproxil fumarate) based nucleoside reverse transcriptase inhibitors (NRTIs)'}, {'label': 'Female (Postmenopausal), TDF', 'description': 'Female (postmenopausal) on regimens containing tenofovir disoproxil fumarate (TDF)'}, {'label': 'Female (Postmenopausal), Non-TDF', 'description': 'Female (postmenopausal) on non-TDF (tenofovir disoproxil fumarate) based NRTIs'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-8020', 'city': 'Graz', 'country': 'Austria', 'facility': 'LKH Graz West', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': 'A6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Medizinische Universitaet Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': 'A-4021', 'city': 'Linz', 'country': 'Austria', 'facility': 'AKh Allgemeines Krankenhaus der Stadt Linz GmbH', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '1140', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Otto Wagner Spital', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'A-1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medizinische Universitat Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Saint-Pierre University Hospital', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CUB Hopital Erasme- Free University of Brussels', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires St. LUC (UCL)', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Centre Hospitalier Universitaire Sart Tilman Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '93000', 'city': 'Bobigny', 'country': 'France', 'facility': 'Hôpital - Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '33075', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Hôpital Saint André', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Groupe Hospitalier Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '92380', 'city': 'Garches', 'country': 'France', 'facility': 'Hôpital Raymond Poincaré', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}, {'zip': '69004', 'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Croix-Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Maladie Infectieuses et Tropicales', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75020', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33604', 'city': 'Pessac', 'country': 'France', 'facility': 'Hopital Haut-Leveque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '59208', 'city': 'Tourcoing', 'country': 'France', 'facility': 'Centre Hospitalier de Tourcoing', 'geoPoint': {'lat': 50.72391, 'lon': 3.16117}}, {'zip': '10777', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Gemeinschaftspaxis Dres. Jessen & Kollegen', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13347', 'city': 'Berlin', 'country': 'Germany', 'facility': 'MVZ Ärzteforum Seestraße', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite-Universitatsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'MIB Dienstleistung GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '53127', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Hopital Saint Antoine', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Universitatsklinik Koln (AöR)', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '40237', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Center for HIV and Hepatogastroenterology', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Universitatsklinikum Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '45122', 'city': 'Essen', 'country': 'Germany', 'facility': 'Universitäts-Hautklinik Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Klinikum der Johann Wolfgang Goethe Universitaet', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '20146', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Infektionsmedizinisches Centrum Hamburg (ICH)', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätskrankenhaus Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '80335', 'city': 'München', 'country': 'Germany', 'facility': 'MUC Research GmbH', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '80336', 'city': 'München', 'country': 'Germany', 'facility': 'Klinikum der Universität München-Großhadern', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '7', 'city': 'Dublin', 'country': 'Ireland', 'facility': 'UCD School of Medicine and Medical Sciences', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '16132', 'city': 'Genova', 'country': 'Italy', 'facility': 'Universitaria San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '20157', 'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale Luigi Sacco', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20127', 'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale San Raffaele Turro', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20142', 'city': 'Milan', 'country': 'Italy', 'facility': 'Azienda Ospedale San Paolo', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '41124', 'city': 'Modena', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria di Modena Policlinico', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'zip': '65124', 'city': 'Pescara', 'country': 'Italy', 'facility': 'Ospedale Civile Spirito Santo', 'geoPoint': {'lat': 42.4584, 'lon': 14.20283}}, {'zip': '00149', 'city': 'Rome', 'country': 'Italy', 'facility': 'Istituto Nazionale per le Malattie Infettive', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '3015', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3584CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '50043', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Wroclawskie Centrum Zdrowia SP ZOZ', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '2755-009', 'city': 'Alcabideche', 'country': 'Portugal', 'facility': 'HPP Hospital de Cascais Dr. José de Almeida', 'geoPoint': {'lat': 38.73366, 'lon': -9.40928}}, {'zip': '1169-050', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Hospital Santo António Capuchos', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '1649-035', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Hospital de Santa Maria', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '4200-319', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Hospital de Sao Joao, E.P.E.', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '4369-004', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Hospital Joaquim Urbano', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '08916', 'city': 'Badalona', 'country': 'Spain', 'facility': 'Hospital Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Vall D'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '20014', 'city': 'Donostia / San Sebastian', 'country': 'Spain', 'facility': 'Hospital Donostia', 'geoPoint': {'lat': 43.31283, 'lon': -1.97499}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41685', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital - Dpt of Infectious Diseases, SU/Östra', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': 'S-17176', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital - Dept of Infectious Diseases', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': 'CH-3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Universitätsklinik für Infektiologie', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '9007', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Cantons Hospital St. Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'zip': 'B15 2TH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'B4 6DH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Whittall Street Clinic', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'B9 5SS', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Birmingham Heartlands Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BN2 3EW', 'city': 'Brighton', 'country': 'United Kingdom', 'facility': 'Brighton & Sussex University Hospitals', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}, {'zip': 'E1 1BB', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'E9 6SR', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Homerton University Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NW3 2QC', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Free Hospital and University College London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE1 8WA', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Kings College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW10 9NH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Chelsea & Westminster Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW17 0QT', 'city': 'London', 'country': 'United Kingdom', 'facility': "St. George's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W2 1NY', 'city': 'London', 'country': 'United Kingdom', 'facility': "Imperial College Healthcare NHS Trust St. Mary's Campus", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M12 0FH', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester Centre for Sexual Health', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Hiba Graham, Pharm D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}