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

An observational study of HIV Infections, run by Gilead Sciences at 73 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: HIV Infections
How many people: 476 participants
Where: 73 sitesin 13 countries
Study dates: Feb 2013to Oct 2014
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Show all 12Show fewer

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

Who cannot join

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)

Trial locations and contacts

73 sites in 13 countries.

Country

City, postcode or hospital

73 sites in 13 countries

Germany14 sites

Gemeinschaftspaxis Dres. Jessen & Kollegen
Berlin, 10777
MVZ Ärzteforum Seestraße
Berlin, 13347
Charite-Universitatsmedizin Berlin
Berlin, 13353
MIB Dienstleistung GmbH
Berlin, 13353
Hopital Saint Antoine
Bonn, 53127
Universitatsklinik Koln (AöR)
Cologne, 50937
Center for HIV and Hepatogastroenterology
Düsseldorf, 40237
Universitatsklinikum Erlangen
Erlangen, 91054
Universitäts-Hautklinik Essen
Essen, 45122
Klinikum der Johann Wolfgang Goethe Universitaet
Frankfurt, 60590
Infektionsmedizinisches Centrum Hamburg (ICH)
Hamburg, 20146
Universitätskrankenhaus Eppendorf
Hamburg, 20246
MUC Research GmbH
München, 80335
Klinikum der Universität München-Großhadern
München, 80336

Other trials in Germany

United Kingdom12 sites

Queen Elizabeth Hospital
Birmingham, B15 2TH
Whittall Street Clinic
Birmingham, B4 6DH
Birmingham Heartlands Hospital
Birmingham, B9 5SS
Brighton & Sussex University Hospitals
Brighton, BN2 3EW
Royal London Hospital
London, E1 1BB
Homerton University Hospital
London, E9 6SR
Royal Free Hospital and University College London Hospital
London, NW3 2QC
Kings College London
London, SE1 8WA
Chelsea & Westminster Hospital
London, SW10 9NH
St. George's Hospital
London, SW17 0QT
Imperial College Healthcare NHS Trust St. Mary's Campus
London, W2 1NY
Manchester Centre for Sexual Health
Manchester, M12 0FH

Other trials in United Kingdom

France10 sites

Hôpital - Avicenne
Bobigny, 93000
Hôpital Saint André
Bordeaux, 33075
Groupe Hospitalier Pellegrin
Bordeaux, 33076
Hôpital Raymond Poincaré
Garches, 92380
Hôpital Croix-Rousse
Lyon, 69004
Maladie Infectieuses et Tropicales
Paris, 75010
Hôpital Cochin
Paris, 75014
Hopital Tenon
Paris, 75020
Hopital Haut-Leveque
Pessac, 33604
Centre Hospitalier de Tourcoing
Tourcoing, 59208

Other trials in France

Italy8 sites

Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna, 40138
Universitaria San Martino
Genova, 16132
Ospedale Luigi Sacco
Milan, 20157
Ospedale San Raffaele Turro
Milan, 20127
Azienda Ospedale San Paolo
Milan, 20142
Azienda Ospedaliero-Universitaria di Modena Policlinico
Modena, 41124
Ospedale Civile Spirito Santo
Pescara, 65124
Istituto Nazionale per le Malattie Infettive
Rome, 00149

Other trials in Italy

Spain6 sites

Hospital Germans Trias i Pujol
Badalona, 08916
Hospital Vall D'Hebron
Barcelona, 08035
Hospital Donostia
Donostia / San Sebastian, 20014
Hospital Ramón y Cajal
Madrid, 28034
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Virgen del Rocio
Seville, 41013

Other trials in Spain

Austria5 sites

LKH Graz West
Graz, A-8020
Medizinische Universitaet Innsbruck
Innsbruck, A6020
AKh Allgemeines Krankenhaus der Stadt Linz GmbH
Linz, A-4021
Otto Wagner Spital
Vienna, 1140
Medizinische Universitat Wien
Vienna, A-1090

Other trials in Austria

Belgium5 sites

CHU Saint-Pierre University Hospital
Brussels, 1000
CUB Hopital Erasme- Free University of Brussels
Brussels, 1070
Cliniques Universitaires St. LUC (UCL)
Brussels, 1200
UZ Leuven
Leuven, 3000
Centre Hospitalier Universitaire Sart Tilman Liège
Liège, 4000

Other trials in Belgium

Portugal5 sites

HPP Hospital de Cascais Dr. José de Almeida
Alcabideche, 2755-009
Hospital Santo António Capuchos
Lisbon, 1169-050
Hospital de Santa Maria
Lisbon, 1649-035
Hospital de Sao Joao, E.P.E.
Porto, 4200-319
Hospital Joaquim Urbano
Porto, 4369-004

Other trials in Portugal

Netherlands2 sites

Erasmus MC
Rotterdam, 3015
University Medical Center Utrecht
Utrecht, 3584CX

Other trials in Netherlands

Sweden2 sites

Sahlgrenska University Hospital - Dpt of Infectious Diseases, SU/Östra
Gothenburg, 41685
Karolinska University Hospital - Dept of Infectious Diseases
Stockholm, S-17176

Other trials in Sweden

Switzerland2 sites

Universitätsklinik für Infektiologie
Bern, CH-3010
Cantons Hospital St. Gallen
Sankt Gallen, 9007

Other trials in Switzerland

Ireland1 site

UCD School of Medicine and Medical Sciences
Dublin, 7

Other trials in Ireland

Poland1 site

Wroclawskie Centrum Zdrowia SP ZOZ
Wroclaw, 50043

Other trials in Poland

About this study

Conditions: HIV Infections
Keywords: Treatment Experienced, Male greater than or equal to 50 years, Female postmenopausal
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01850212
Study group	Role	What they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 1

Secondary outcomes (2)

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.
Measured: Day 1
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.
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2013Oct 2014

First posted9 May 2013 (estimated)
Study startFeb 2013
Primary completionOct 2014
Study completionOct 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by Gilead SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 476 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01850212
Sponsor's protocol ID: GS-US-104-0423
Other IDs: 2011-004420-35
Status last verified: Oct 2014
First submitted: 28 Mar 2013
Last updated: 31 Oct 2014
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects
ClinicalTrials.gov ID: NCT01850212
Acronym / sponsor ID: GS-US-104-0423
Conditions: HIV Infections
Keywords: Treatment Experienced, Male greater than or equal to 50 years, Female postmenopausal
Study type: Observational
Recruitment status: Completed
Enrolment: 476 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: Feb 2013
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 9 May 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 4

Arm	Type	Receives
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

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Study population of ≥ 50 year old male subjects and post-menopausal female subjects

Key inclusion criteria (12 listed)

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):
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

Key exclusion criteria (2 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

2 secondary outcomes

Observed T-score < -2 (yes/no) for femoral neck and spine (L1-4)
Time frame: Day 1
Observed -2 ≤ T-score < -1 (yes/no) for femoral neck and spine (L1-4)
Time frame: Day 1

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.

Related trials for HIV Infections

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
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Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
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HIV, HIV Treatment
Recruiting
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Mental Health
RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hiba Graham, Pharm D study director

Gilead Sciences

73 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, run by Gilead Sciences at 73 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in Germany, United Kingdom, France, Italy, Spain and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Femoral Neck and Spine (L1-4) T-score (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01850212.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2014.