A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects
- Conditions
- HIV Infections
- Registration Number
- NCT01850212
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 476
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Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
-
HIV-1 infected subjects regardless of race or ethnicity
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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):
- TDF plus PI/r-containing regimen including subjects who switched from one TDF plus PI/r regimen to another TDF plus PI/r regimen
- 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
- 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
- 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
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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))
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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
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Male subjects must be ≥ 50 years of age
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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
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Adequate records available to evaluate medical history for the 3 years prior to study entry
- Subject has a contraindication to dual-energy X-ray absorptiometry (DEXA) scans
- Subject has a history of osteoporosis before initiating Highly Active Antiretroviral Treatment (HAART)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Femoral Neck and Spine (L1-4) T-score Day 1 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.
- Secondary Outcome Measures
Name Time Method Observed T-score < -2 (yes/no) for femoral neck and spine (L1-4) Day 1 Observed T-score for femoral neck and spine will be used to further characterize low BMD.
Observed -2 ≤ T-score < -1 (yes/no) for femoral neck and spine (L1-4) Day 1 Observed T-score for femoral neck and spine will be used to further characterize low BMD.
Trial Locations
- Locations (73)
Universitäts-Hautklinik Essen
🇩🇪Essen, Germany
Universitatsklinik Koln (AöR)
🇩🇪Koln, Germany
Klinikum der Universität München-Großhadern
🇩🇪Munchen, Germany
Ospedale San Raffaele Turro
🇮🇹Milano, Italy
Hospital Joaquim Urbano
🇵🇹Porto, Portugal
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Birmingham Heartlands Hospital
🇬🇧Birmingham, United Kingdom
Universitätsklinik für Infektiologie
🇨🇭Bern, Switzerland
Brighton & Sussex University Hospitals
🇬🇧Brighton, United Kingdom
Kings College London
🇬🇧London, United Kingdom
Royal Free Hospital and University College London Hospital
🇬🇧London, United Kingdom
Chelsea & Westminster Hospital
🇬🇧London, United Kingdom
Manchester Centre for Sexual Health
🇬🇧Manchester, United Kingdom
AKh Allgemeines Krankenhaus der Stadt Linz GmbH
🇦🇹Linz, Austria
CUB Hopital Erasme- Free University of Brussels
🇧🇪Brussels, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
CHU Saint-Pierre University Hospital
🇧🇪Brussels, Belgium
Cliniques Universitaires St. LUC (UCL)
🇧🇪Brussels, Belgium
Centre Hospitalier Universitaire Sart Tilman Liège
🇧🇪Liege, Belgium
UCD School of Medicine and Medical Sciences
🇮🇪Dublin, Ireland
Medizinische Universitaet Innsbruck
🇦🇹Innsbruck, Austria
Hospital de Santa Maria
🇵🇹Lisboa, Portugal
Wroclawskie Centrum Zdrowia SP ZOZ
🇵🇱Wroclaw, Poland
Hospital Santo António Capuchos
🇵🇹Lisboa, Portugal
Erasmus MC
🇳🇱Rotterdam, Netherlands
Hospital de Sao Joao, E.P.E.
🇵🇹Porto, Portugal
Hôpital Saint André
🇫🇷Bordeaux, France
Hôpital Raymond Poincaré
🇫🇷Garches, France
Centre Hospitalier de Tourcoing
🇫🇷Tourcoing, France
Maladie Infectieuses et Tropicales
🇫🇷Paris, France
MVZ Ärzteforum Seestraße
🇩🇪Berlin, Germany
MIB Dienstleistung GmbH
🇩🇪Berlin, Germany
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
🇮🇹Bologna, Italy
Universitaria San Martino
🇮🇹Genova, Italy
Azienda Ospedaliero-Universitaria di Modena Policlinico
🇮🇹Modena, Italy
Istituto Nazionale per le Malattie Infettive
🇮🇹Rome, Italy
Hôpital - Avicenne
🇫🇷Bobigny, France
Groupe Hospitalier Pellegrin
🇫🇷Bordeaux, France
Hopital Haut-Leveque
🇫🇷Pessac, France
Hôpital Cochin
🇫🇷Paris, France
Klinikum der Johann Wolfgang Goethe Universitaet
🇩🇪Frankfurt, Germany
LKH Graz West
🇦🇹Graz, Austria
Otto Wagner Spital
🇦🇹Vienna, Austria
Medizinische Universitat Wien
🇦🇹Vienna, Austria
Center for HIV and Hepatogastroenterology
🇩🇪Dusseldorf, Germany
Hôpital Croix-Rousse
🇫🇷Lyon, France
Hopital Tenon
🇫🇷Paris, France
Charite-Universitatsmedizin Berlin
🇩🇪Berlin, Germany
Hopital Saint Antoine
🇩🇪Bonn, Germany
Universitatsklinikum Erlangen
🇩🇪Erlangen, Germany
Ospedale Luigi Sacco
🇮🇹Milan, Italy
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
MUC Research GmbH
🇩🇪Munchen, Germany
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Azienda Ospedale San Paolo
🇮🇹Milano, Italy
Ospedale Civile Spirito Santo
🇮🇹Pescara, Italy
Hospital Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital Donostia
🇪🇸San Sebastian, Spain
Hospital Vall D'Hebron
🇪🇸Barcelona, Spain
Sahlgrenska University Hospital - Dpt of Infectious Diseases, SU/Östra
🇸🇪Gothenburg, Sweden
Homerton University Hospital
🇬🇧London, United Kingdom
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Cantons Hospital St. Gallen
🇨🇭St. Gallen, Switzerland
Whittall Street Clinic
🇬🇧Birmingham, United Kingdom
Karolinska University Hospital - Dept of Infectious Diseases
🇸🇪Stockholm, Sweden
Royal London Hospital
🇬🇧London, United Kingdom
Imperial College Healthcare NHS Trust St. Mary's Campus
🇬🇧London, United Kingdom
St. George's Hospital
🇬🇧London, United Kingdom
HPP Hospital de Cascais Dr. José de Almeida
🇵🇹Alcabideche, Portugal
Infektionsmedizinisches Centrum Hamburg (ICH)
🇩🇪Hamburg, Germany
Gemeinschaftspaxis Dres. Jessen & Kollegen
🇩🇪Berlin, Germany
Universitätskrankenhaus Eppendorf
🇩🇪Hamburg, Germany
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands