Randomized controlled parallel open-label study in persons living with HIV. The aim is to study weight changes in patients switching from a dolutegravir and tenofovir disoproxil containing regimen to either a dolutegravir or tenofovir disoproxil free regimen.
Randomized controlled parallel open-label study in persons living with HIV and at least 6 month of treatment with dolutegravir/abacavir/lamivudine prior to inclusion. Participants (n=126) are randomized to continue 3 drug-regimen dolutegravir/tenofovir disoproxil/lamivudine (control) or switch to two-drug regimen with dolutegravir/lamivudine (intervention 1) or to three-drug regimen with doravirine/tenofovir disoproxil/lamivudine. 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 virus persistent viral suppression, changes in body composition and metabolism, changes in bone metabolisme and renal function, changes in liver elasticity and fat infiltration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
Two-drug therapy
Department of Infectious Diseases, Aalborg University Hospital
Aalborg, Denmark
NOT_YET_RECRUITINGDepartment of Infectious Diseases, Aarhus University Hospital
Aarhus, Denmark
NOT_YET_RECRUITINGDepartment of Infectious Diseases, Rigshospitalet
Copenhagen, Denmark
NOT_YET_RECRUITINGDepartment of Infectious Diseases, Hvidovre University Hospital
Hvidovre, Denmark
RECRUITINGDepartment of Infectious Diseases, Odense University Hospital
Odense, Denmark
NOT_YET_RECRUITINGBody weight
Primary outcome is a change in body weight of more than 2 kg from
Time frame: 48 Weeks
Virological control
Plasma HIV-RNA \<50 copies/ml
Time frame: 48 weeks
Self-rated health
Changes in 12-item Short Form Health Survey (SF-12). Scores from 0 (worse) to 100 (best).
Time frame: 48 weeks
Insulin resistance
Impaired insulin resistance and/or β-cell function determined by changes in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame: 48 weeks
Diabetic profile
Changes in HbA1c
Time frame: 48 weeks
Cholesterol profile
Changes in cholesterol total, HDL, LDL, VLDL
Time frame: 48 weeks
Fat distribution
Changes in Visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) determined by thoracic and upper abdominal CT-scan.
Time frame: 48 weeks
Hepatic elasticity
Changes in hepativ elasticity determined by liver elastography (Fibro-scan)
Time frame: 48 weeks
Hepatic fat infiltration
Changes in hepatic fat infiltration determined by liver elastography (Fibro-scan) and upper abdominal CT-scan
Time frame: 48 weeks
Body composition/perfiferal and central fat distribution
Changes in body fat distribtuion determined bu Dual Energy X-ray Absorbtiometry (DEXA)
Time frame: 48 weeks
Estimated Glomerular Filtration Rate (eGFR) (creatinine)
Changes in eGFR estimated by plasma creatinine
Time frame: 48 weeks
eGFR (cystatin)
Changes in estimated by plasma cystatin
Time frame: 48 weeks
Urea
Changes in plasma urea
Time frame: 48 weeks
Urine RBP/creatinine ratio
Changes in Urine RBP/creatinine ratio determined by spot urine Retinol Binding Protein (RBP) and creatinine analysis
Time frame: 48 weeks
Urine Beta-2-Microglobulin(B2M)/creatinine ratio
Changes in B2M/creatinine ratio determined by spot urine B2M and creatinine
Time frame: 48 weeks
Urine albumin/creatinine ratio
Changes in Urine albumin/creatinine ratio determined by spot urine albumine and creatinine analysis
Time frame: 48 weeks
Urine protein/creatinine ratio
Changes in urine protein/creatinine ratio determined by spot urine protein and creatinine analysis
Time frame: 48 weeks
Urine phosphate
Changes in spot urine phosphate
Time frame: 48 weeks
Bone mass density (BMD)
Changes in BMD assessed by DEXA
Time frame: 48 weeks
Bone-specific alkaline phosphate
Changes in plasma Bone-specific alkaline phosphate
Time frame: 48 weeks
Procollagen type 1 N-pro-peptide
Changes in procollagen type 1 N-pro-peptide
Time frame: 48 weeks
Type 1 collagen cross-linked C-telopeptide
Changes in plasma Type 1 collagen cross-linked C-telopeptide
Time frame: 48 weeks
Osteocalcin
Changes in plasma osteocalcin
Time frame: 48 weeks
Fasting ionized calcium
Changes in plasma fasting ionized calcium
Time frame: 48 weeks
25(OH)vitamin D vitamin D 25(OH)vitamin D
Changes in plasma 25(OH)vitamin D
Time frame: 48 weeks
Parathyroid hormone (PTH) vitamin D 25(OH)vitamin D
Changes in plasma parathyroid hormone (PTH)
Time frame: 48 weeks
Inflammation
High-sensitive C-reactive protein
Time frame: 48 weeks
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