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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850212
• Other study ID #: GS-US-104-0423
• Secondary ID: 2011-004420-35
• Status: Completed
• Phase: Phase 4
• First received: March 28, 2013
• Last updated: October 30, 2014
• Start date: February 2013
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices AgencyBelgium: Federal Agency for Medicines and Health Products, FAMHPFrance: Agence Nationale de Sécurité du Médicament et des produits de santéGermany: Federal Institute for Drugs and Medical DevicesIreland: Irish Medicines BoardItaly: The Italian Medicines AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Portugal: INFARMED, National Authority of Medicines and Health Products, IPSpain: Agencia Española de Medicamentos y Productos SanitariosSwitzerland: SwissmedicUnited Kingdom: Medicines and Healthcare Products Regulatory AgencySweden: Medical Products Agency
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 476
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
Austria	LKH Graz West	Graz
Austria	Medizinische Universitaet Innsbruck	Innsbruck
Austria	AKh Allgemeines Krankenhaus der Stadt Linz GmbH	Linz
Austria	Medizinische Universitat Wien	Vienna
Austria	Otto Wagner Spital	Vienna
Belgium	CHU Saint-Pierre University Hospital	Brussels
Belgium	Cliniques Universitaires St. LUC (UCL)	Brussels
Belgium	CUB Hopital Erasme- Free University of Brussels	Brussels
Belgium	UZ Leuven	Leuven
Belgium	Centre Hospitalier Universitaire Sart Tilman Liège	Liege
France	Hôpital - Avicenne	Bobigny
France	Groupe Hospitalier Pellegrin	Bordeaux
France	Hôpital Saint André	Bordeaux
France	Hôpital Raymond Poincaré	Garches
France	Hôpital Croix-Rousse	Lyon
France	Hôpital Cochin	Paris
France	Hopital Tenon	Paris
France	Maladie Infectieuses et Tropicales	Paris
France	Hopital Haut-Leveque	Pessac
France	Centre Hospitalier de Tourcoing	Tourcoing
Germany	Charite-Universitatsmedizin Berlin	Berlin
Germany	Gemeinschaftspaxis Dres. Jessen & Kollegen	Berlin
Germany	MIB Dienstleistung GmbH	Berlin
Germany	MVZ Ärzteforum Seestraße	Berlin
Germany	Hopital Saint Antoine	Bonn
Germany	Center for HIV and Hepatogastroenterology	Dusseldorf
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	Universitatsklinik Koln (AöR)	Koln
Germany	Klinikum der Universität München-Großhadern	Munchen
Germany	MUC Research GmbH	Munchen
Ireland	UCD School of Medicine and Medical Sciences	Dublin
Italy	Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi	Bologna
Italy	Universitaria San Martino	Genova
Italy	Ospedale Luigi Sacco	Milan
Italy	Azienda Ospedale San Paolo	Milano
Italy	Ospedale San Raffaele Turro	Milano
Italy	Azienda Ospedaliero-Universitaria di Modena Policlinico	Modena
Italy	Ospedale Civile Spirito Santo	Pescara
Italy	Istituto Nazionale per le Malattie Infettive	Rome
Netherlands	Erasmus MC	Rotterdam
Netherlands	University Medical Center Utrecht	Utrecht
Poland	Wroclawskie Centrum Zdrowia SP ZOZ	Wroclaw
Portugal	HPP Hospital de Cascais Dr. José de Almeida	Alcabideche
Portugal	Hospital de Santa Maria	Lisboa
Portugal	Hospital Santo António Capuchos	Lisboa
Portugal	Hospital de Sao Joao, E.P.E.	Porto
Portugal	Hospital Joaquim Urbano	Porto
Spain	Hospital Germans Trias i Pujol	Badalona
Spain	Hospital Vall D'Hebron	Barcelona
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Donostia	San Sebastian
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Sweden	Sahlgrenska University Hospital - Dpt of Infectious Diseases, SU/Östra	Gothenburg
Sweden	Karolinska University Hospital - Dept of Infectious Diseases	Stockholm
Switzerland	Universitätsklinik für Infektiologie	Bern
Switzerland	Cantons Hospital St. Gallen	St. Gallen
United Kingdom	Birmingham Heartlands Hospital	Birmingham
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Whittall Street Clinic	Birmingham
United Kingdom	Brighton & Sussex University Hospitals	Brighton
United Kingdom	Chelsea & Westminster Hospital	London
United Kingdom	Homerton University Hospital	London
United Kingdom	Imperial College Healthcare NHS Trust St. Mary's Campus	London
United Kingdom	Kings College London	London
United Kingdom	Royal Free Hospital and University College London Hospital	London
United Kingdom	Royal London Hospital	London
United Kingdom	St. George's Hospital	London
United Kingdom	Manchester Centre for Sexual Health	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Ireland,  Italy,  Netherlands,  Poland,  Portugal,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Femoral Neck and Spine (L1-4) T-score	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	Yes
Secondary	Observed T-score < -2 (yes/no) for femoral neck and spine (L1-4)	Observed T-score for femoral neck and spine will be used to further characterize low BMD.	Day 1	Yes
Secondary	Observed -2 = T-score < -1 (yes/no) for femoral neck and spine (L1-4)	Observed T-score for femoral neck and spine will be used to further characterize low BMD.	Day 1	Yes