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

Terminated

• Conditions: HIV-1; Treatment-naïve

• Registration Number: NCT03708289
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief 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.

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 Timeline

• Status Verified: 2016-09
• Study Start: 2016-09
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Study First Submitted: 2018-10-12
• Study First Submitted QC: 2018-10-12
• Last Update Submitted: 2018-10-12
• Study First Posted: 2018-10-17
• Last Update Posted: 2018-10-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of changes in BMD from baseline	144 weeks of follow-up
Assessment of changes in trunk fat from baseline	144 weeks of follow-up
Determination of the incidence of subclinical and clinical hypothyroidism	Within 144 weeks of follow-up

Secondary Outcome Measures

Name	Time	Method
Correlation between T-scores obtained by Achilles bone ultrasonometer (screening tool) and hip and spine DXA scan (gold standard)	144 weeks of follow-up
Correlations between changes in body composition and endocrine values	144 weeks of follow-up
Correlation between changes in VAT and trunk fat and changes in waist circumference	144 weeks of follow-up
Description of changes in body composition in relation to the resting energy expenditure	144 weeks of follow-up

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Jette, Belgium