Clinical trial NCT01850212: A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects
Official title: A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Treatment Experienced
Male greater than or equal to 50 years
Female postmenopausal
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-05-09
Enrollment: 476
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Study population of ≥ 50 year old male subjects and post-menopausal female subjects

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


Eligibility 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)

Primary outcomes:
measure: Femoral Neck and Spine (L1-4) T-score
timeFrame: Day 1
Secondary outcomes:
measure: Observed T-score < -2 (yes/no) for femoral neck and spine (L1-4)
timeFrame: Day 1
measure: Observed -2 ≤ T-score < -1 (yes/no) for femoral neck and spine (L1-4)
timeFrame: Day 1
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH Graz West
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck
city: Linz
country: Austria
facility: AKh Allgemeines Krankenhaus der Stadt Linz GmbH
city: Vienna
country: Austria
facility: Otto Wagner Spital
city: Vienna
country: Austria
facility: Medizinische Universitat Wien
city: Brussels
country: Belgium
facility: CHU Saint-Pierre University Hospital
city: Brussels
country: Belgium
facility: CUB Hopital Erasme- Free University of Brussels
city: Brussels
country: Belgium
facility: Cliniques Universitaires St. LUC (UCL)
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire Sart Tilman Liège
city: Bobigny
country: France
facility: Hôpital - Avicenne
city: Bordeaux
country: France
facility: Hôpital Saint André
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin
city: Garches
country: France
facility: Hôpital Raymond Poincaré
city: Lyon
country: France
facility: Hôpital Croix-Rousse
city: Paris
country: France
facility: Maladie Infectieuses et Tropicales
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hopital Tenon
city: Pessac
country: France
facility: Hopital Haut-Leveque
city: Tourcoing
country: France
facility: Centre Hospitalier de Tourcoing
city: Berlin
country: Germany
facility: Gemeinschaftspaxis Dres. Jessen & Kollegen
city: Berlin
country: Germany
facility: MVZ Ärzteforum Seestraße
city: Berlin
country: Germany
facility: Charite-Universitatsmedizin Berlin
city: Berlin
country: Germany
facility: MIB Dienstleistung GmbH
city: Bonn
country: Germany
facility: Hopital Saint Antoine
city: Dusseldorf
country: Germany
facility: Center for HIV and Hepatogastroenterology
city: Erlangen
country: Germany
facility: Universitatsklinikum Erlangen
city: Essen
country: Germany
facility: Universitäts-Hautklinik Essen
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe Universitaet
city: Hamburg
country: Germany
facility: Infektionsmedizinisches Centrum Hamburg (ICH)
city: Hamburg
country: Germany
facility: Universitätskrankenhaus Eppendorf
city: Koln
country: Germany
facility: Universitatsklinik Koln (AöR)
city: Munchen
country: Germany
facility: MUC Research GmbH
city: Munchen
country: Germany
facility: Klinikum der Universität München-Großhadern
city: Dublin
country: Ireland
facility: UCD School of Medicine and Medical Sciences
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
city: Genova
country: Italy
facility: Universitaria San Martino
city: Milano
country: Italy
facility: Ospedale San Raffaele Turro
city: Milano
country: Italy
facility: Azienda Ospedale San Paolo
city: Milan
country: Italy
facility: Ospedale Luigi Sacco
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena Policlinico
city: Pescara
country: Italy
facility: Ospedale Civile Spirito Santo
city: Rome
country: Italy
facility: Istituto Nazionale per le Malattie Infettive
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Wroclaw
country: Poland
facility: Wroclawskie Centrum Zdrowia SP ZOZ
city: Alcabideche
country: Portugal
facility: HPP Hospital de Cascais Dr. José de Almeida
city: Lisboa
country: Portugal
facility: Hospital Santo António Capuchos
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria
city: Porto
country: Portugal
facility: Hospital de Sao Joao, E.P.E.
city: Porto
country: Portugal
facility: Hospital Joaquim Urbano
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Vall D'Hebron
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: San Sebastian
country: Spain
facility: Hospital Donostia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital - Dpt of Infectious Diseases, SU/Östra
city: Stockholm
country: Sweden
facility: Karolinska University Hospital - Dept of Infectious Diseases
city: Bern
country: Switzerland
facility: Universitätsklinik für Infektiologie
city: St. Gallen
country: Switzerland
facility: Cantons Hospital St. Gallen
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Birmingham
country: United Kingdom
facility: Whittall Street Clinic
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Brighton
country: United Kingdom
facility: Brighton & Sussex University Hospitals
city: London
country: United Kingdom
facility: Royal London Hospital
city: London
country: United Kingdom
facility: Homerton University Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital and University College London Hospital
city: London
country: United Kingdom
facility: Kings College London
city: London
country: United Kingdom
facility: Chelsea & Westminster Hospital
city: London
country: United Kingdom
facility: St. George's Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust St. Mary's Campus
city: Manchester
country: United Kingdom
facility: Manchester Centre for Sexual Health
Study officials:
affiliation: Gilead Sciences
name: Hiba Graham, Pharm D
role: STUDY_DIRECTOR
References: