A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects
NCT ID: NCT01850212
Last Updated: 2014-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
476 participants
OBSERVATIONAL
2013-02-28
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Male (≥ 50 years), TDF
Male (≥ 50 years of age) on regimens containing tenofovir disoproxil fumarate (TDF)
No interventions assigned to this group
Male (≥ 50 years of age), Non-TDF
Male (≥ 50 years of age) on non-TDF (tenofovir disoproxil fumarate) based nucleoside reverse transcriptase inhibitors (NRTIs)
No interventions assigned to this group
Female (Postmenopausal), TDF
Female (postmenopausal) on regimens containing tenofovir disoproxil fumarate (TDF)
No interventions assigned to this group
Female (Postmenopausal), Non-TDF
Female (postmenopausal) on non-TDF (tenofovir disoproxil fumarate) based NRTIs
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* HIV-1 infected subjects regardless of race or ethnicity
* 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
* 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))
* 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
* Male subjects must be ≥ 50 years of age
* 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
* Adequate records available to evaluate medical history for the 3 years prior to study entry
Exclusion Criteria
* Subject has a history of osteoporosis before initiating Highly Active Antiretroviral Treatment (HAART)
50 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Hiba Graham, Pharm D
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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LKH Graz West
Graz, , Austria
Medizinische Universitaet Innsbruck
Innsbruck, , Austria
AKh Allgemeines Krankenhaus der Stadt Linz GmbH
Linz, , Austria
Otto Wagner Spital
Vienna, , Austria
Medizinische Universitat Wien
Vienna, , Austria
CHU Saint-Pierre University Hospital
Brussels, , Belgium
CUB Hopital Erasme- Free University of Brussels
Brussels, , Belgium
Cliniques Universitaires St. LUC (UCL)
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
Centre Hospitalier Universitaire Sart Tilman Liège
Liège, , Belgium
Hôpital - Avicenne
Bobigny, , France
Hôpital Saint André
Bordeaux, , France
Groupe Hospitalier Pellegrin
Bordeaux, , France
Hôpital Raymond Poincaré
Garches, , France
Hôpital Croix-Rousse
Lyon, , France
Maladie Infectieuses et Tropicales
Paris, , France
Hôpital Cochin
Paris, , France
Hopital Tenon
Paris, , France
Hopital Haut-Leveque
Pessac, , France
Centre Hospitalier de Tourcoing
Tourcoing, , France
Gemeinschaftspaxis Dres. Jessen & Kollegen
Berlin, , Germany
MVZ Ärzteforum Seestraße
Berlin, , Germany
Charite-Universitatsmedizin Berlin
Berlin, , Germany
MIB Dienstleistung GmbH
Berlin, , Germany
Hopital Saint Antoine
Bonn, , Germany
Universitatsklinik Koln (AöR)
Cologne, , Germany
Center for HIV and Hepatogastroenterology
Düsseldorf, , Germany
Universitatsklinikum Erlangen
Erlangen, , Germany
Universitäts-Hautklinik Essen
Essen, , Germany
Klinikum der Johann Wolfgang Goethe Universitaet
Frankfurt, , Germany
Infektionsmedizinisches Centrum Hamburg (ICH)
Hamburg, , Germany
Universitätskrankenhaus Eppendorf
Hamburg, , Germany
MUC Research GmbH
München, , Germany
Klinikum der Universität München-Großhadern
München, , Germany
UCD School of Medicine and Medical Sciences
Dublin, , Ireland
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna, , Italy
Universitaria San Martino
Genova, , Italy
Ospedale Luigi Sacco
Milan, , Italy
Ospedale San Raffaele Turro
Milan, , Italy
Azienda Ospedale San Paolo
Milan, , Italy
Azienda Ospedaliero-Universitaria di Modena Policlinico
Modena, , Italy
Ospedale Civile Spirito Santo
Pescara, , Italy
Istituto Nazionale per le Malattie Infettive
Rome, , Italy
Erasmus MC
Rotterdam, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
Wroclawskie Centrum Zdrowia SP ZOZ
Wroclaw, , Poland
HPP Hospital de Cascais Dr. José de Almeida
Alcabideche, , Portugal
Hospital Santo António Capuchos
Lisbon, , Portugal
Hospital de Santa Maria
Lisbon, , Portugal
Hospital de Sao Joao, E.P.E.
Porto, , Portugal
Hospital Joaquim Urbano
Porto, , Portugal
Hospital Germans Trias i Pujol
Badalona, , Spain
Hospital Vall D'Hebron
Barcelona, , Spain
Hospital Donostia
Donostia / San Sebastian, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Sahlgrenska University Hospital - Dpt of Infectious Diseases, SU/Östra
Gothenburg, , Sweden
Karolinska University Hospital - Dept of Infectious Diseases
Stockholm, , Sweden
Universitätsklinik für Infektiologie
Bern, , Switzerland
Cantons Hospital St. Gallen
Sankt Gallen, , Switzerland
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Whittall Street Clinic
Birmingham, , United Kingdom
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Brighton & Sussex University Hospitals
Brighton, , United Kingdom
Royal London Hospital
London, , United Kingdom
Homerton University Hospital
London, , United Kingdom
Royal Free Hospital and University College London Hospital
London, , United Kingdom
Kings College London
London, , United Kingdom
Chelsea & Westminster Hospital
London, , United Kingdom
St. George's Hospital
London, , United Kingdom
Imperial College Healthcare NHS Trust St. Mary's Campus
London, , United Kingdom
Manchester Centre for Sexual Health
Manchester, , United Kingdom
Countries
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Other Identifiers
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2011-004420-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-104-0423
Identifier Type: -
Identifier Source: org_study_id