Changes in Weight, Body Composition and Cardiac Risk After Discontinuing Abacavir Treatment in HIV-infected Individuals
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Randomized controlled parallel open-label study in people living with HIV and at least 6
month of treatment with dolutegravir/abacavir/lamivudine prior to inclusion.
Participants (n=95) are randomized to continue 3 drug-regimen
dolutegravir/abacavir/lamivudine (control) or switch to two-drug regimen with
dolutegravir/lamivudine (intervention). Follow-up is 48 weeks. Data is collected at baseline
and week 48. Primary outcome is changes in weight from baseline of more than 2 kg. Secondary
outcomes are changes in cardiac risk, composition and calcification of the heart tissue, and
changes in body composition and metabolism, inflammation and coagulation. A MRI substudy is
applied to focus on the cardiac adverse effects of abacavir.