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

NCT03708289 | Terminated

• 1 other identifier: UZB BONBO
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1; Treatment-naïve

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Interventions

DXA scan RADIATION

total and hip and spine dual energy x-ray absorptiometry

Achilles bone US OTHER

Medical body composition measurements OTHER

Resting energy expenditure measurement OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-1 infected patients aged 18 years or more, antiretroviral treatment naïve

You may qualify if:

• 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

You may not qualify if:

• Pregnancy and breastfeeding
• Patients receiving medical care through an 'emergency care package'

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Jette, 1090, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood and urine samples

MeSH Terms

Interventions

Absorptiometry, Photon

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Sabine D Allard, PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: October 17, 2018
• Study Start: September 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 17, 2018

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)