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

October 30, 2014 updated by: Gilead Sciences
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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

476

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, A-8020
        • LKH Graz West
      • Innsbruck, Austria, A6020
        • Medizinische Universitaet Innsbruck
      • Linz, Austria, A-4021
        • AKh Allgemeines Krankenhaus der Stadt Linz GmbH
      • Vienna, Austria, A-1090
        • Medizinische Universität Wien
      • Vienna, Austria, 1140
        • Otto Wagner Spital
  • Belgium
      • Brussels, Belgium, 1000
        • CHU Saint-Pierre University Hospital
      • Brussels, Belgium, 1200
        • Cliniques Universitaires St. Luc (UCL)
      • Brussels, Belgium, 1070
        • CUB Hopital Erasme- Free University of Brussels
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liege, Belgium, 4000
        • Centre Hospitalier Universitaire Sart Tilman Liège
  • France
      • Bobigny, France, 93000
        • Hôpital - Avicenne
      • Bordeaux, France, 33075
        • Hopital Saint André
      • Bordeaux, France, 33076
        • Groupe Hospitalier Pellegrin
      • Garches, France, 92380
        • Hôpital Raymond Poincaré
      • Lyon, France, 69004
        • Hôpital Croix-Rousse
      • Paris, France, 75020
        • Hopital Tenon
      • Paris, France, 75014
        • Hôpital Cochin
      • Paris, France, 75010
        • Maladie Infectieuses et Tropicales
      • Pessac, France, 33604
        • Hôpital Haut-Lévèque
      • Tourcoing, France, 59208
        • Centre Hospitalier de Tourcoing
  • Germany
      • Berlin, Germany, 13353
        • Charite-Universitatsmedizin Berlin
      • Berlin, Germany, 13353
        • MIB Dienstleistung GmbH
      • Berlin, Germany, 10777
        • Gemeinschaftspaxis Dres. Jessen & Kollegen
      • Berlin, Germany, 13347
        • MVZ Ärzteforum Seestraße
      • Bonn, Germany, 53127
        • Hopital Saint Antoine
      • Dusseldorf, Germany, 40237
        • Center for HIV and Hepatogastroenterology
      • Erlangen, Germany, 91054
        • Universitätsklinikum Erlangen
      • Essen, Germany, 45122
        • Universitäts-Hautklinik Essen
      • Frankfurt, Germany, 60590
        • Klinikum der Johann Wolfgang Goethe Universitaet
      • Hamburg, Germany, 20246
        • Universitätskrankenhaus Eppendorf
      • Hamburg, Germany, 20146
        • Infektionsmedizinisches Centrum Hamburg (ICH)
      • Koln, Germany, 50937
        • Universitatsklinik Koln (AöR)
      • Munchen, Germany, 80335
        • MUC Research GmbH
      • Munchen, Germany, 80336
        • Klinikum der Universität München-Großhadern
  • Ireland
      • Dublin, Ireland, 7
        • UCD School of Medicine and Medical Sciences
  • Italy
      • Bologna, Italy, 40138
        • Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
      • Genova, Italy, 16132
        • Universitaria San Martino
      • Milan, Italy, 20157
        • Ospedale Luigi Sacco
      • Milano, Italy, 20142
        • Azienda Ospedale San Paolo
      • Milano, Italy, 20127
        • Ospedale San Raffaele Turro
      • Modena, Italy, 41124
        • Azienda Ospedaliero-Universitaria di Modena Policlinico
      • Pescara, Italy, 65124
        • Ospedale Civile Spirito Santo
      • Rome, Italy, 00149
        • Istituto Nazionale per le Malattie Infettive
  • Netherlands
      • Rotterdam, Netherlands, 3015
        • Erasmus MC
      • Utrecht, Netherlands, 3584CX
        • University Medical Center Utrecht
  • Poland
      • Wroclaw, Poland, 50043
        • Wroclawskie Centrum Zdrowia SP ZOZ
  • Portugal
      • Alcabideche, Portugal, 2755-009
        • HPP Hospital de Cascais Dr. José de Almeida
      • Lisboa, Portugal, 1649-035
        • Hospital de Santa Maria
      • Lisboa, Portugal, 1169-050
        • Hospital Santo António Capuchos
      • Porto, Portugal, 4200-319
        • Hospital de Sao Joao, E.P.E.
      • Porto, Portugal, 4369-004
        • Hospital Joaquim Urbano
  • Spain
      • Badalona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • San Sebastian, Spain, 20014
        • Hospital Donostia
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
  • Sweden
      • Gothenburg, Sweden, 41685
        • Sahlgrenska University Hospital - Dpt of Infectious Diseases, SU/Östra
      • Stockholm, Sweden, S-17176
        • Karolinska University Hospital - Dept of Infectious Diseases
  • Switzerland
      • Bern, Switzerland, CH-3010
        • Universitätsklinik für Infektiologie
      • St. Gallen, Switzerland, 9007
        • Cantons Hospital St. Gallen
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
      • Birmingham, United Kingdom, B4 6DH
        • Whittall Street Clinic
      • Brighton, United Kingdom, BN2 3EW
        • Brighton & Sussex University Hospitals
      • London, United Kingdom, E1 1BB
        • Royal London Hospital
      • London, United Kingdom, SW17 0QT
        • St. George's Hospital
      • London, United Kingdom, SW10 9NH
        • Chelsea & Westminster Hospital
      • London, United Kingdom, E9 6SR
        • Homerton University Hospital
      • London, United Kingdom, NW3 2QC
        • Royal Free Hospital and University College London Hospital
      • London, United Kingdom, SE1 8WA
        • Kings College London
      • London, United Kingdom, W2 1NY
        • Imperial College Healthcare NHS Trust St. Mary's Campus
      • Manchester, United Kingdom, M12 0FH
        • Manchester Centre for Sexual Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Femoral Neck and Spine (L1-4) T-score
Time Frame: 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.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observed T-score < -2 (yes/no) for femoral neck and spine (L1-4)
Time Frame: Day 1
Observed T-score for femoral neck and spine will be used to further characterize low BMD.
Day 1
Observed -2 ≤ T-score < -1 (yes/no) for femoral neck and spine (L1-4)
Time Frame: Day 1
Observed T-score for femoral neck and spine will be used to further characterize low BMD.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Investigators

  • Study Director: Hiba Graham, Pharm D, Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

March 28, 2013

First Submitted That Met QC Criteria

May 7, 2013

First Posted (Estimate)

May 9, 2013

Study Record Updates

Last Update Posted (Estimate)

October 31, 2014

Last Update Submitted That Met QC Criteria

October 30, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-104-0423
  • 2011-004420-35 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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