HIV-1BONBONCT03708289
Body Composition, Bone Health and Hormonal Status in HIV-1-infected Individuals
An observational study of HIV-1 and Treatment-naïve, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Improved survival of people living with HIV has resulted in an increased occurrence of other comorbidities, such as cardiovascular, renal, bone and endocrine pathologies. The data that is currently available on cART-associated changes in bone mineral density, body composition and hormonal values is short-term and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1, Treatment-naïve
- What is being tested?
- DXA scan, Achilles bone US and Medical body composition measurements
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2016to Oct 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV-1 infected patients aged 18 years or more, antiretroviral treatment naïve
Who may be able to join
- Documented and confirmed HIV-1-infection
- Aged 18 years or above
- Naïve to anti-retroviral treatment, unless anti-retrovirals were taken in the context of occupational or non-occupational post-exposure prophylaxis or in the context of prevention of mother-to-child transmission
- Willingness to sign the written informed consent
Who cannot join
- Pregnancy and breastfeeding
- Patients receiving medical care through an 'emergency care package'
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of Body Composition, Bone Health and Hormonal Status After Initiation of an Integrase-inhibitor-based Anti-retroviral Therapy in Treatment-naïve HIV-1-infected Individuals
Improved survival of people living with HIV has resulted in an increased occurrence of other comorbidities, such as cardiovascular, renal, bone and endocrine pathologies.
The data that is currently available on cART-associated changes in bone mineral density, body composition and hormonal values is short-term and mainly derived from patients initiating cART in accordance with previous treatment guidelines. As current guidelines recommend earlier cART initiation and as PI-based regimens are becoming less frequently used, a favorable outcome on bone health, body composition measures and endocrine status might be expected.
This study will therefore prospectively document alterations in bone mineral density, body composition and endocrine status in HIV-infected patients in whom, in the current treatment era, an INSTI-based cART regimen is initiated as a first line regimen.
Read the detailed description
Patients will be included at the initiation of cART. The follow up for this study is planned to fit within the routine follow up consultations and includes some extra experimental investigations, such as the medical body composition measurements, resting energy expenditure measurement, Achilles bone ultrasonometer and DXA scans. Standard blood and urine samples will be taken, including standard analyses and some extra analyses for the study.
Physical activity will be monitored for 5 consecutive days using a bracelet device while patients will be asked to record their food intake using a standardized diet agenda.
Total follow up time will be 144 weeks and includes 12 visits in total.
- Conditions
- HIV-1, Treatment-naïve
- Being tested
- DXA scan, Achilles bone US, Medical body composition measurements, Resting energy expenditure measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DXA scanRadiation
total and hip and spine dual energy x-ray absorptiometry
Achilles bone USOther
Medical body composition measurementsOther
Resting energy expenditure measurementOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of changes in BMD from baseline
Measured: 144 weeks of follow-up
Assessment of changes in trunk fat from baseline
Measured: 144 weeks of follow-up
Determination of the incidence of subclinical and clinical hypothyroidism
Measured: Within 144 weeks of follow-up
Secondary outcomes (4)
Correlation between T-scores obtained by Achilles bone ultrasonometer (screening tool) and hip and spine DXA scan (gold standard)
Measured: 144 weeks of follow-up
Correlations between changes in body composition and endocrine values
Measured: 144 weeks of follow-up
Correlation between changes in VAT and trunk fat and changes in waist circumference
Measured: 144 weeks of follow-up
Description of changes in body composition in relation to the resting energy expenditure
Measured: 144 weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study startSep 2016
- Primary completionOct 2018
- Study completionOct 2018
Why it stopped: recruitment slower than expected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1Studies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine D Allard, PhD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708289
- Sponsor's protocol ID
- UZB BONBO
- Acronym
- BONBO
- Status last verified
- Sep 2016
- First submitted
- 12 Oct 2018
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Body Composition, Bone Health and Hormonal Status After Initiation of an Integrase-inhibitor-based Anti-retroviral Therapy in Treatment-naïve HIV-1-infected Individuals
- ClinicalTrials.gov ID
- NCT03708289
- Acronym / sponsor ID
- BONBO / UZB BONBO
- Conditions
- HIV-1, Treatment-naïve
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruitment slower than expected
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 17 Oct 2018 (actual)
- 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.
Improved survival of people living with HIV has resulted in an increased occurrence of other comorbidities, such as cardiovascular, renal, bone and endocrine pathologies.
The data that is currently available on cART-associated changes in bone mineral density, body composition and hormonal values is short-term and mainly derived from patients initiating cART in accordance with previous treatment guidelines. As current guidelines recommend earlier cART initiation and as PI-based regimens are becoming less frequently used, a favorable outcome on bone health, body composition measures and endocrine status might be expected.
This study will therefore prospectively document alterations in bone mineral density, body composition and endocrine status in HIV-infected patients in whom, in the current treatment era, an INSTI-based cART regimen is initiated as a first line regimen.
Detailed description
Patients will be included at the initiation of cART. The follow up for this study is planned to fit within the routine follow up consultations and includes some extra experimental investigations, such as the medical body composition measurements, resting energy expenditure measurement, Achilles bone ultrasonometer and DXA scans. Standard blood and urine samples will be taken, including standard analyses and some extra analyses for the study.
Physical activity will be monitored for 5 consecutive days using a bracelet device while patients will be asked to record their food intake using a standardized diet agenda.
Total follow up time will be 144 weeks and includes 12 visits in total.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-1 infected patients aged 18 years or more, antiretroviral treatment naïve
Key inclusion criteria (4 listed)
- Documented and confirmed HIV-1-infection
- Aged 18 years or above
- Naïve to anti-retroviral treatment, unless anti-retrovirals were taken in the context of occupational or non-occupational post-exposure prophylaxis or in the context of prevention of mother-to-child transmission
- Willingness to sign the written informed consent
Key exclusion criteria (2 listed)
- Pregnancy and breastfeeding
- Patients receiving medical care through an 'emergency care package'
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DXA scantotal and hip and spine dual energy x-ray absorptiometry | Radiation | – |
| Achilles bone US | Other | – |
| Medical body composition measurements | Other | – |
| Resting energy expenditure measurement | Other | – |
Primary outcome
Assessment of changes in BMD from baseline
Time frame: 144 weeks of follow-up
Assessment of changes in trunk fat from baseline
Time frame: 144 weeks of follow-up
Determination of the incidence of subclinical and clinical hypothyroidism
Time frame: Within 144 weeks of follow-up
4 secondary outcomes
Correlation between T-scores obtained by Achilles bone ultrasonometer (screening tool) and hip and spine DXA scan (gold standard)
Time frame: 144 weeks of follow-up
Correlations between changes in body composition and endocrine values
Time frame: 144 weeks of follow-up
Correlation between changes in VAT and trunk fat and changes in waist circumference
Time frame: 144 weeks of follow-up
Description of changes in body composition in relation to the resting energy expenditure
Time frame: 144 weeks of follow-up
Results and safety
The study was stopped early (reason given: recruitment slower than expected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Sabine D Allard, PhD principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1 and Treatment-naïve, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 4 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: stopped early, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 was stopped early (reason given: recruitment slower than expected). Results are not available in the source record.
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?
Assessment of changes in BMD from baseline (time frame: 144 weeks of follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2018.