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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01850212
First received: March 28, 2013
Last updated: October 30, 2014
Last verified: October 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.


Enrollment: 476
Study Start Date: February 2013
Study Completion Date: October 2014
Primary Completion Date: October 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

  Hide Study Locations
Locations
Austria
LKH Graz West
Graz, Austria, A-8020
Medizinische Universitaet Innsbruck
Innsbruck, Austria, A6020
AKh Allgemeines Krankenhaus der Stadt Linz GmbH
Linz, Austria, A-4021
Medizinische Universitat Wien
Vienna, Austria, A-1090
Otto Wagner Spital
Vienna, Austria, 1140
Belgium
CHU Saint-Pierre University Hospital
Brussels, Belgium, 1000
Cliniques Universitaires St. LUC (UCL)
Brussels, Belgium, 1200
CUB Hopital Erasme- Free University of Brussels
Brussels, Belgium, 1070
UZ Leuven
Leuven, Belgium, 3000
Centre Hospitalier Universitaire Sart Tilman Liège
Liege, Belgium, 4000
France
Hôpital - Avicenne
Bobigny, France, 93000
Groupe Hospitalier Pellegrin
Bordeaux, France, 33076
Hôpital Saint André
Bordeaux, France, 33075
Hôpital Raymond Poincaré
Garches, France, 92380
Hôpital Croix-Rousse
Lyon, France, 69004
Hopital Tenon
Paris, France, 75020
Hôpital Cochin
Paris, France, 75014
Maladie Infectieuses et Tropicales
Paris, France, 75010
Hopital Haut-Leveque
Pessac, France, 33604
Centre Hospitalier de Tourcoing
Tourcoing, France, 59208
Germany
Charite-Universitatsmedizin Berlin
Berlin, Germany, 13353
Gemeinschaftspaxis Dres. Jessen & Kollegen
Berlin, Germany, 10777
MIB Dienstleistung GmbH
Berlin, Germany, 13353
MVZ Ärzteforum Seestraße
Berlin, Germany, 13347
Hopital Saint Antoine
Bonn, Germany, 53127
Center for HIV and Hepatogastroenterology
Dusseldorf, Germany, 40237
Universitatsklinikum Erlangen
Erlangen, Germany, 91054
Universitäts-Hautklinik Essen
Essen, Germany, 45122
Klinikum der Johann Wolfgang Goethe Universitaet
Frankfurt, Germany, 60590
Infektionsmedizinisches Centrum Hamburg (ICH)
Hamburg, Germany, 20146
Universitätskrankenhaus Eppendorf
Hamburg, Germany, 20246
Universitatsklinik Koln (AöR)
Koln, Germany, 50937
Klinikum der Universität München-Großhadern
Munchen, Germany, 80336
MUC Research GmbH
Munchen, Germany, 80335
Ireland
UCD School of Medicine and Medical Sciences
Dublin, Ireland, 7
Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna, Italy, 40138
Universitaria San Martino
Genova, Italy, 16132
Ospedale Luigi Sacco
Milan, Italy, 20157
Azienda Ospedale San Paolo
Milano, Italy, 20142
Ospedale San Raffaele Turro
Milano, Italy, 20127
Azienda Ospedaliero-Universitaria di Modena Policlinico
Modena, Italy, 41124
Ospedale Civile Spirito Santo
Pescara, Italy, 65124
Istituto Nazionale per le Malattie Infettive
Rome, Italy, 00149
Netherlands
Erasmus MC
Rotterdam, Netherlands, 3015
University Medical Center Utrecht
Utrecht, Netherlands, 3584CX
Poland
Wroclawskie Centrum Zdrowia SP ZOZ
Wroclaw, Poland, 50043
Portugal
HPP Hospital de Cascais Dr. José de Almeida
Alcabideche, Portugal, 2755-009
Hospital de Santa Maria
Lisboa, Portugal, 1649-035
Hospital Santo António Capuchos
Lisboa, Portugal, 1169-050
Hospital de Sao Joao, E.P.E.
Porto, Portugal, 4200-319
Hospital Joaquim Urbano
Porto, Portugal, 4369-004
Spain
Hospital Germans Trias i Pujol
Badalona, Spain, 08916
Hospital Vall D'Hebron
Barcelona, Spain, 08035
Hospital Ramón y Cajal
Madrid, Spain, 28034
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Donostia
San Sebastian, Spain, 20014
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Sweden
Sahlgrenska University Hospital - Dpt of Infectious Diseases, SU/Östra
Gothenburg, Sweden, 41685
Karolinska University Hospital - Dept of Infectious Diseases
Stockholm, Sweden, S-17176
Switzerland
Universitätsklinik für Infektiologie
Bern, Switzerland, CH-3010
Cantons Hospital St. Gallen
St. Gallen, Switzerland, 9007
United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom, B9 5SS
Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
Whittall Street Clinic
Birmingham, United Kingdom, B4 6DH
Brighton & Sussex University Hospitals
Brighton, United Kingdom, BN2 3EW
Chelsea & Westminster Hospital
London, United Kingdom, SW10 9NH
Homerton University Hospital
London, United Kingdom, E9 6SR
Imperial College Healthcare NHS Trust St. Mary's Campus
London, United Kingdom, W2 1NY
Kings College London
London, United Kingdom, SE1 8WA
Royal Free Hospital and University College London Hospital
London, United Kingdom, NW3 2QC
Royal London Hospital
London, United Kingdom, E1 1BB
St. George's Hospital
London, United Kingdom, SW17 0QT
Manchester Centre for Sexual Health
Manchester, United Kingdom, M12 0FH
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: October 30, 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
Sweden: Medical Products Agency

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

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

ClinicalTrials.gov processed this record on November 24, 2014