Human immunodeficiency viruses (HIV) MedDRA version: 21.1 Level: PT Classification code 10067326 Term: Antiretroviral therapy System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Triumeq
Pharmaceutical Form: Tablet
CAS Number: 188062-50-2
Other descriptive name: ABACAVIR SULFATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600
Sponsors
Department of infectious diseases, Hvidovre Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Individuals = 18 years old with - Diagnosed HIV and - At least 6 months of ongoing treatment with dolutegravir/ abacavir/lamivudine prior to inclusion - No pre-existing viral resistance mutations to lamivudine or to dolutegravir - Plasma viral load (HIV-RNA) =65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: - Pre-existing viral resistance mutations to lamivudine or to dolutegravir - Presence of hepatitis B antigen (HBsAg) or HBV DNA - Cancer within past 5 years - Pregnancy or breastfeeding - Any case of diabetes or cardiovascular disease must be stable as assessed by the treating physician - Women of reproductive potential will be included if using approved contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to investigate if discontinuing abacavir by switching from a 3 drug regimen with with dolutegravir /abacavir/lamivudine to a 2 drug regimen with dolutegravir/lamivudine will cause changes in weight, and in metabolic and cardiac parameters in individuals infected with HIV.;Secondary Objective: Not applicable;Primary end point(s): Primary outcome is defined by changes in body weight of more than 2 kg from baseline to week 48.;Timepoint(s) of evaluation of this end point: 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety Virological control at 48 weeks of follow up as defined by a plasma HIV-RNA <50 copies/ml Selfrated health • 12-Item Short Form Survey (SF-12) Metabolism • Development of metabolic syndrome or diabetes • Impaired insulin resistance and/or ß-cell function determined by changes in HOMA-IR Changes in: • Framingham Risk Score • HbA1c, cholesterol total, HDL, LDL, VLDL, triglycerides • Fat distribution evaluated as o Visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) determined by abdominal CT o Hepatic steatosis: Development of steatosis or increase in steatosis from baseline (CT and liver elastography) o Fat distribution in trunk, limb and extremities measured by DEXA Cardiac Changes in from baseline to week 48 in: • Blood pressure and pulse • Cardiac magnetic resonance imaging (MRI) • Carotid artery intima-media thickness (cIMT) measured by ultra sound • Coronary artery calcium score (CACS) • N-terminal pro-B-type natriuretic peptide (Pro-BNP), Troponin T (TnT) Inflammation, endothelial function, platelet function and coagulation Changes in from baseline to week 48 in: • Inflammation: High-sensitive C-reactive protein, interleukin 1- and 6. • Endothelial function: Vascular cell adhesion molecule 1 and intercellular adhesion molecule 1. • Platelet function: soluble P-selectin and soluble glycoprotein VI. • Coagulation: D-dimer, factor 2, 7 and 10 (extrinsic pathway) and fibrinogen • General: Leucocytes, hemoglobin, platelets, creatinine, urea, sodium, potassium, bilirubin, alanine aminotransferase. ;Timepoint(s) of evaluation of this end point: 48 weeks | — |
Countries
Denmark
Contacts
Public ContactKaren Brorup Heje Pedersen
Department of infectious diseases, Hvidovre Hospital
Outcome results
None listed