A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01850212
First received: March 28, 2013
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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


Condition Phase
HIV Infections
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Femoral Neck and Spine (L1-4) T-score [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    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:
  • Observed T-score < -2 (yes/no) for femoral neck and spine (L1-4) [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Observed T-score for femoral neck and spine will be used to further characterize low BMD.


Estimated Enrollment: 480
Study Start Date: February 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Male (≥ 50 years), TDF
Male (≥ 50 years of age) on regimens containing tenofovir disoproxil fumarate (TDF)
Male (≥ 50 years of age), Non-TDF
Male (≥ 50 years of age) on non-TDF (tenofovir disoproxil fumarate) based nucleoside reverse transcriptase inhibitors (NRTIs)
Female (Postmenopausal), TDF
Female (postmenopausal) on regimens containing tenofovir disoproxil fumarate (TDF)
Female (Postmenopausal), Non-TDF
Female (postmenopausal) on non-TDF (tenofovir disoproxil fumarate) based NRTIs

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Study population of ≥ 50 year old male subjects and post-menopausal female subjects

Criteria

Inclusion Criteria:

  • 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
  • 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 contraindication to dual-energy X-ray absorptiometry (DEXA) scans
  • Subject has a history of osteoporosis before initiating Highly Active Antiretroviral Treatment (HAART)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01850212

Contacts
Contact: Gilead Study Team Clin-ops-intl@gilead.com

  Hide Study Locations
Locations
Austria
LKH Graz West Recruiting
Graz, Austria, A-8020
Contact    +43 316546614312      
Medizinische Universitaet Innsbruck Recruiting
Innsbruck, Austria, A6020
Contact    +43 512 504 81072      
AKh Allgemeines Krankenhaus der Stadt Linz GmbH Recruiting
Linz, Austria, A-4021
Contact    +43 732 7806-3730      
Medizinische Universitat Wien Recruiting
Vienna, Austria, A-1090
Contact    +43 1 40 400 6540      
Otto Wagner Spital Recruiting
Vienna, Austria, 1140
Contact    +43-1-91060-42131      
Belgium
CHU Saint-Pierre University Hospital Recruiting
Brussels, Belgium, 1000
Contact    +32 2 535 41 20      
CUB Hopital Erasme- Free University of Brussels Recruiting
Brussels, Belgium, 1070
Contact    +32 2 555 8181      
Cliniques Universitaires St. LUC (UCL) Recruiting
Brussels, Belgium, 1200
Contact    +32 2 764 2190      
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact    +32 16 344275      
Centre Hospitalier Universitaire Sart Tilman Liège Recruiting
Liege, Belgium, 4000
Contact    +3243667235      
France
Hôpital - Avicenne Recruiting
Bobigny, France, 93000
Contact    +33148955421      
Hôpital Saint André Recruiting
Bordeaux, France, 33075
Contact    +33556795733      
Groupe Hospitalier Pellegrin Recruiting
Bordeaux, France, 33076
Contact    +33 5 56 79 55 23      
Hôpital Raymond Poincaré Recruiting
Garches, France, 92380
Contact    +33 1 47 10 77 72      
Hôpital Croix-Rousse Recruiting
Lyon, France, 69004
Contact    +33 4 72 07 24 81      
Maladie Infectieuses et Tropicales Recruiting
Paris, France, 75010
Contact    +33 1 42 49 90 66      
Hopital Lariboisiere Withdrawn
Paris, France, 75010
Hôpital Cochin Recruiting
Paris, France, 75014
Contact    +33 1 58 41 21 34      
Hopital Tenon Recruiting
Paris, France, 75020
Contact    +33 156017436      
Hopital Haut-Leveque Recruiting
Pessac, France, 33604
Contact    +33 1 5 57 65 64 83      
CHU Rennes - Hôpital de Pontchaillou Withdrawn
Rennes, France, 35033
Centre Hospitalier de Tourcoing Not yet recruiting
Tourcoing, France, 59208
Contact    +33320694617      
Germany
MIB Dienstleistung GmbH Recruiting
Berlin, Germany, 13353
Contact    +030-4519889416      
Gemeinschaftspaxis Dres. Jessen & Kollegen Not yet recruiting
Berlin, Germany, 10777
Contact    +49 30 23510745      
Charite-Universitatsmedizin Berlin Recruiting
Berlin, Germany, 13353
Contact    +49-30-450 653 318      
MVZ Ärzteforum Seestraße Recruiting
Berlin, Germany, 13347
Contact    +49(30) 455 095-0      
Hopital Saint Antoine Recruiting
Bonn, Germany, 53127
Contact    +4922828719556      
Center for HIV and Hepatogastroenterology Recruiting
Dusseldorf, Germany, 40237
Contact    +49 211-239552-55      
Universitatsklinikum Erlangen Not yet recruiting
Erlangen, Germany, 91054
Contact    +49-9131-8543004      
Universitäts-Hautklinik Essen Recruiting
Essen, Germany, 45122
Contact    +492017233696      
Klinikum der Johann Wolfgang Goethe Universitaet Recruiting
Frankfurt, Germany, 60590
Contact    +49 69 6301-7478      
Universitätskrankenhaus Eppendorf Recruiting
Hamburg, Germany, 20246
Contact    +49407410552682      
Infektionsmedizinisches Centrum Hamburg (ICH) Recruiting
Hamburg, Germany, 20146
Contact    +49 40 413242 0      
Medizinische Hochschule Hannover Withdrawn
Hannover, Germany, 30625
Universitatsklinik Koln (AöR) Recruiting
Koln, Germany, 50937
Contact    +49 221-478 5860      
Klinikum der Universität München-Großhadern Recruiting
Munchen, Germany, 80336
Contact    +498951603598      
MUC Research GmbH Recruiting
Munchen, Germany, 80335
Contact    + 4989558 70 30      
Ireland
UCD School of Medicine and Medical Sciences Recruiting
Dublin, Ireland, 7
Contact    +353 1 7164599      
Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi Not yet recruiting
Bologna, Italy, 40138
Contact    +39 328 2644329      
Universitaria San Martino Not yet recruiting
Genova, Italy, 16132
Contact    +39 010 35 37 677      
Ospedale Luigi Sacco Recruiting
Milan, Italy, 20157
Contact    +39 02 39043490      
Ospedale San Raffaele Turro Recruiting
Milano, Italy, 20127
Contact    +39 0226437934      
Azienda Ospedale San Paolo Not yet recruiting
Milano, Italy, 20142
Contact    +39 3299059962      
Azienda Ospedaliero-Universitaria di Modena Policlinico Recruiting
Modena, Italy, 41124
Contact    +390594222466      
Ospedale Civile Spirito Santo Recruiting
Pescara, Italy, 65124
Contact    +39 3288442883      
Istituto Nazionale per le Malattie Infettive Recruiting
Rome, Italy, 00149
Contact    +390655170480      
Netherlands
Erasmus MC Recruiting
Rotterdam, Netherlands, 3015
Contact    +31 107 033510      
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584CX
Contact    +88-7555555      
Poland
Wroclawskie Centrum Zdrowia SP ZOZ Recruiting
Wroclaw, Poland, 50043
Contact    +48 71 356 07 80      
Portugal
HPP Hospital de Cascais Dr. José de Almeida Not yet recruiting
Alcabideche, Portugal, 2755-009
Contact    +351 214653000      
Centro Hospitalar e Universitario de Coimbra Withdrawn
Coimbra, Portugal, 3046-853
Centro Hospitalar e Universitário de Coimbra, EPE Withdrawn
Coimbra, Portugal, 3000-075
Hospital Santo António Capuchos Recruiting
Lisboa, Portugal, 1169-050
Contact    +315912288422      
Hospital de Santa Maria Not yet recruiting
Lisboa, Portugal, 1649-035
Contact    +351217938043      
Hospital de Sao Joao, E.P.E. Not yet recruiting
Porto, Portugal, 4200-319
Contact    +351225512100      
Hospital Joaquim Urbano Not yet recruiting
Porto, Portugal, 4369-004
Contact    +351 225 899 550      
Spain
Hospital Germans Trias i Pujol Recruiting
Badalona, Spain, 08916
Contact    +34 93 497 88 49      
Hospital Vall D'Hebron Recruiting
Barcelona, Spain, 08035
Contact    +34 93 489 44 97      
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact    +34 91 727 70 99      
Hospital Ramón y Cajal Not yet recruiting
Madrid, Spain, 28034
Contact    (+34) 91 336 91 00      
Hospital Donostia Recruiting
San Sebastian, Spain, 20014
Contact    +34 94 300 73 74      
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Spain, 41013
Contact    +34 955 01 30 96      
Switzerland
Universitätsklinik für Infektiologie Recruiting
Bern, Switzerland, CH-3010
Contact    +41 31 632 88 44      
Cantons Hospital St. Gallen Recruiting
St. Gallen, Switzerland, 9007
Contact    +41 71 494 26 62      
United Kingdom
Queen Elizabeth Hospital Recruiting
Birmingham, United Kingdom, B15 2TH
Contact    +44 208 836 5768      
Whittall Street Clinic Recruiting
Birmingham, United Kingdom, B4 6DH
Contact    +44121 237 5707      
Birmingham Heartlands Hospital Recruiting
Birmingham, United Kingdom, B9 5SS
Contact    +44 121 424 1604      
Brighton & Sussex University Hospitals Not yet recruiting
Brighton, United Kingdom, BN2 3EW
Contact    +441273523079      
Royal Free Hospital and University College London Hospital Recruiting
London, United Kingdom, NW3 2QC
Contact    +44 207 942 1836      
Royal London Hospital Recruiting
London, United Kingdom, E1 1BB
Contact    +44 203 594 6773      
Chelsea & Westminster Hospital Recruiting
London, United Kingdom, SW10 9NH
Contact    +44 208 746 5628      
Kings College London Recruiting
London, United Kingdom, SE1 8WA
Contact    +44 207 848 5776      
St. George's Hospital Recruiting
London, United Kingdom, SW17 0QT
Contact    +44 20 8725 3423      
Guy's & St. Thomas' NHS Trust Withdrawn
London, United Kingdom, SE1 7EH
Imperial College Healthcare NHS Trust St. Mary's Campus Recruiting
London, United Kingdom, W2 1NY
Contact    +44 20 3312 1464      
Homerton University Hospital Recruiting
London, United Kingdom, E9 6SR
Contact    +44 208 510 5785      
Manchester Centre for Sexual Health Recruiting
Manchester, United Kingdom, M12 0FH
Contact    +44 161 701 1504      
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Hiba Graham, Pharm D Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01850212     History of Changes
Other Study ID Numbers: GS-US-104-0423, 2011-004420-35
Study First Received: March 28, 2013
Last Updated: August 15, 2014
Health Authority: Austria: Austrian Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicines and Health Products, FAMHP
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Ireland: Irish Medicines Board
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Portugal: INFARMED, National Authority of Medicines and Health Products, IP
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Gilead Sciences:
Treatment Experienced
Male greater than or equal to 50 years
Female postmenopausal

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Reverse Transcriptase Inhibitors
Tenofovir disoproxil
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 26, 2014