HIV-1 Clinical Trial
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
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.
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.
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