NCT03708289

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV-1
• Treatment-naïve

Interventions

Type	Name	Description
RADIATION	DXA scan	total and hip and spine dual energy x-ray absorptiometry
OTHER	Achilles bone US
OTHER	Medical body composition measurements
OTHER	Resting energy expenditure measurement

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2018-10-17
• Last updated: 2018-10-17

Locations

1 site across 1 country: Belgium