Effect on Liver Fat and Metabolic Parameters When Switching a Protease Inhibitor or Efavirenz to Raltegravir
Status:
Completed
Trial end date:
2019-11-30
Target enrollment:
Participant gender:
Summary
This study will provide data on the switch from a protease inhibitor or efavirenz to the new
formulation of raltegravir (RAL) dosed once daily. The study group consists of patients with
metabolic risk factors and co-morbidities, in need of optimization of their current ART to
minimize the drug-related metabolic side effects as standard of care.
The primary objective of this study is to investigate whether switching a protease inhibitor
(PI) or efavirenz to raltegravir once daily reduces liver fat in patients who are overweight
or obese and have at least one metabolic syndrome component. For this purpose, the liver fat
content will be analyzed using the proton magnetic resonance spectroscopy.
In addition, the aim is to clarify the change in the body composition and metabolism in this
study group. For this purpose the visceral adipose tissue (VAT) and subcutaneous adipose
tissue (SAT) volumes will be measured and subcutaneous tissue samples will be collected for
future analyses of adipose tissue function.