Clinical trial NCT03708289: Body Composition, Bone Health and Hormonal Status in HIV-1-infected Individuals
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: HIV-1
Treatment-naïve
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-1 infected patients aged 18 years or more, antiretroviral treatment naïve

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.

Eligibility criteria: 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'

Primary outcomes:
measure: Assessment of changes in BMD from baseline
timeFrame: 144 weeks of follow-up
measure: Assessment of changes in trunk fat from baseline
timeFrame: 144 weeks of follow-up
measure: Determination of the incidence of subclinical and clinical hypothyroidism
timeFrame: Within 144 weeks of follow-up
Secondary outcomes:
measure: Correlation between T-scores obtained by Achilles bone ultrasonometer (screening tool) and hip and spine DXA scan (gold standard)
timeFrame: 144 weeks of follow-up
measure: Correlations between changes in body composition and endocrine values
timeFrame: 144 weeks of follow-up
measure: Correlation between changes in VAT and trunk fat and changes in waist circumference
timeFrame: 144 weeks of follow-up
measure: Description of changes in body composition in relation to the resting energy expenditure
timeFrame: 144 weeks of follow-up
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Sabine D Allard, PhD
role: PRINCIPAL_INVESTIGATOR
References: