- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03708289
Body Composition, Bone Health and Hormonal Status in HIV-1-infected Individuals (BONBO)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Jette, Belgium, 1090
- UZ Brussel
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnancy and breastfeeding
- Patients receiving medical care through an 'emergency care package'
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of changes in BMD from baseline
Time Frame: 144 weeks of follow-up
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144 weeks of follow-up
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Assessment of changes in trunk fat from baseline
Time Frame: 144 weeks of follow-up
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144 weeks of follow-up
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Determination of the incidence of subclinical and clinical hypothyroidism
Time Frame: Within 144 weeks of follow-up
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Within 144 weeks of follow-up
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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144 weeks of follow-up
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Correlations between changes in body composition and endocrine values
Time Frame: 144 weeks of follow-up
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144 weeks of follow-up
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Correlation between changes in VAT and trunk fat and changes in waist circumference
Time Frame: 144 weeks of follow-up
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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
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144 weeks of follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sabine D Allard, PhD, Universitair Ziekenhuis Brussel
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UZB BONBO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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