Body Composition, Bone Health and Hormonal Status in HIV-1-infected Individuals

HIV-1 Clinical Trial

— BONBO  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03708289
• Other study ID #: UZB BONBO
• Status: Terminated
• Start date: September 2016
• Est. completion date: October 2018

Study information

• Verified date: September 2016
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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'

Related Conditions & MeSH terms

• HIV-1
• Treatment-naïve

Intervention

Radiation:
• DXA scan
total and hip and spine dual energy x-ray absorptiometry

Other:
• Achilles bone US

• Medical body composition measurements

• Resting energy expenditure measurement

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of changes in BMD from baseline		144 weeks of follow-up
Primary	Assessment of changes in trunk fat from baseline		144 weeks of follow-up
Primary	Determination of the incidence of subclinical and clinical hypothyroidism		Within 144 weeks of follow-up
Secondary	Correlation between T-scores obtained by Achilles bone ultrasonometer (screening tool) and hip and spine DXA scan (gold standard)		144 weeks of follow-up
Secondary	Correlations between changes in body composition and endocrine values		144 weeks of follow-up
Secondary	Correlation between changes in VAT and trunk fat and changes in waist circumference		144 weeks of follow-up
Secondary	Description of changes in body composition in relation to the resting energy expenditure		144 weeks of follow-up