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.
In the MRI sub study 40 patients from the main study (20 from each group) are included. A cardiac MRI are performed at baseline and week 48 to evaluate cardiac effects of abacavir.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
81
Discontinuing abacavir by switching from three-drug regimen with dolutegravir/abacavir/lamivudine to two-drug regimen with dolutegravir/lamivudine
Copenhagen University Hospital - Rigshospitalet
Copenhagen, Denmark
Copenhagen University Hospital, Amager Hvidovre
Hvidovre, Denmark
Changes in body weight of ≥2 kg
Fasting body weight
Time frame: 48 weeks
Virological control
HIV-RNA \<50 copies/ml
Time frame: 48 weeks
Changes in self-rated health
12-item Short Form Health Survey (SF-12). Scores from 0 (worse) to 100 (best).
Time frame: 48 weeks
Change in metabolism
Impaired insulin resistance and/or β-cell function determined by changes in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame: 48 weeks
Changes in cardiac risk
D:A:D CVD risk score: Five and ten years predicted cardio vascular disease risk (percent)
Time frame: 48 weeks
Changes in carotid artery intima-media thickness (cIMT)
Measured by ultrasound.
Time frame: 48 weeks
Changes in Coronary artery calcium score (CACS)
Measures by CT-scan. Scores from 0 and with no upper limit. The higher score, the worse calcification/plaque level and higher CVD risk.
Time frame: 48 weeks
Changes in cardiac blood markers
Changes in N-terminal pro-B-type natriuretic peptide (Pro-BNP)
Time frame: 48 weeks
Changes in bloodpressure
Systolic and diastolic blood pressure (mmHg)
Time frame: 48 weeks
Changes in fat distribution VAT/SAT
Measured by CT-scan • Visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) determined by abdominal CT.
Time frame: 48 weeks
Changes in liver stiffness
Measured by CT-scan and liver elastography
Time frame: 48 weeks
Changes in liver fat infiltration
Measured by CT-scan and liver elastography
Time frame: 48 weeks
Changes in fat distribution in trunk, limb and extremities
Measured by dual energy xray absorptiometry (DEXA)
Time frame: 48 weeks
Changes in inflammation
High-sensitive C-reactive protein
Time frame: 48 weeks
Changes in interleukins
Interleukin 1- and interleukin 6
Time frame: 48 weeks
Changes in endothelial function
Vascular cell adhesion molecule 1 and intercellular adhesion molecule 1
Time frame: 48 weeks
Changes in soluble P-selectin
soluble P-selectin
Time frame: 48 weeks
Changes in soluble glycoprotein VI
soluble glycoprotein VI
Time frame: 48 weeks
Changes in d-dimer
D-dimer
Time frame: 48 weeks
Changes in coagulation
Factor 2, 7 and 10 (extrinsic pathway)
Time frame: 48 weeks
Changes in fibrinogen
Fibrinogen
Time frame: 48 weeks
Changes in blood Hemoglobin
Hemoglobin
Time frame: 48 weeks
Changes in blood platelets
Platelets
Time frame: 48 weeks
Changes in plasma creatinine
Creatinine
Time frame: 48 weeks
Changes in plasma urea
Urea
Time frame: 48 weeks
Changes in plasma sodium
Sodium
Time frame: 48 weeks
Changes in plasma potassium
Potassium
Time frame: 48 weeks
Changes in plasma bilirubin
Bilirubin
Time frame: 48 weeks
Changes in plasma alanine
Alanine
Time frame: 48 weeks
Changes in plasma aminotransferase
Aminotransferase
Time frame: 48 weeks
Cardiovascular risk
Framingham risk score: Estimated 10 years risk of cardiovascular disease (percent)
Time frame: 48 weeks
Cardiac biomarkers
Changes in Troponin T (TnT)
Time frame: 48 weeks
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