Changes in weight, body composition and metabolic parameters after switch to either dolutegravir/lamivudine or doravirine/tenofovir/lamivudine compared to continued treatment with dolutegravir/tenofovir/lamivudine for virologically suppressed HIV infection: A randomized open-label superiority trial.

INTERVENTION: Trade Name: Viread Pharmaceutical Form: Tablet INN or Proposed INN: TENOFOVIR DISOPROXIL FUMARATE CAS Number: 202138‐50‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 245‐ Trade Name: Delstrigo Pharmaceutical Form: Tablet INN or Proposed INN: TENOFOVIR DISOPROXIL FUMARATE CAS Number: 202138‐50‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 245‐ INN or Proposed INN: DORAVIRINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ INN or Proposed INN: LAMIVUDINE CAS Number: 134678‐17‐4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300‐ Trade Name: Dovato Pharmaceutical Form: Tablet INN or Proposed INN: LAMIVUDINE CAS Number: 134678‐17‐4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300‐ INN or Proposed INN: DOLUTEGRAVIR SODIUM Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Trade Name: Tenofovir disproxil "Sandoz" Pharmaceutical Form: Tablet INN or Proposed INN: TENOFOVIR DISOPROXIL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 245‐ Trade Name: Tenofovir disproxil "Stada" Pharmaceutical Form: Tablet INN or Proposed INN: TENOFOVIR DISOPROXIL SUCCINATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 245‐ Trade Name: Tenofovir disproxil "TEVA" Pharmaceutical Form: Tablet INN or Proposed INN: TENOFOVIR DISOPROXIL PHOSPHATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 245‐ Trade Name: Tenofovir disproxil "Accordpharma" Pharmaceutical Form: Tablet INN or Proposed INN: TENOFOVIR DISOPROXIL Concentration unit: mg milligram(s) Concentrat CONDITION: Human immunodeficiency virus (HIV) ; MedDRA version: 21.1 Level: PT Classification code 10067326 Term: Antiretroviral therapy System Organ Class: 10042613 ‐ Surgical and medical procedures Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] PRIMARY OUTCOME: Main Objective: The aim of the study is to investigate if discontinuing dolutegravir or tenofovirdisproxil by switching from dolutegravir+tenofovir disoproxil+lamivudine to dolutegravir/lamivudine or doravirin/tenofovirdisproxil/lamivudine will cause changes in weight and metabolic parameters in individuals infected with HIV. Primary end point(s): Changes in body weight of more than 2 kg from baseline to week 48. Secondary Objective: Not applicable Timepoint(s) of evaluation of this end point: 48 weeks INCLUSION CRITERIA: ‐ Individuals >18 years ‐ Diagnosed HIV ‐ At least 6 months of ongoing treatment with dolutegravir/ tenofovirdisproxil/lamivudin prior to inclusion ‐ Plasma viral load (HIV‐RNA) < 50 copies/ml ‐ Women of reproductive potential will be included if using approved contraception. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 126 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range SECONDARY OUTCOME: Secondary end point(s): p‐HIV<50 copies/ml; Metabolic syndrome or diabetes; Changes in: SF‐12;HOMA‐IR;Framingham Risko Score; HbA1c;cholesterol:Total;HDL;LDL;VLDL;triglycerides;visceral adipose tissue(VAT);subcutaneous adipose tissue(SAT) determined by abdominal CT;Hepatic steatosis(CT and liver elastography);Fat distribution in trunk, limb and extremities (DEXA); Plasma cystatin and creatinin;eGFR;urea; Urine: RBP/creatinine ratio;B2M/creatinine ratio;albumin/creatinine ratio;phosphate; High sensitive CRP; BMD and BMC (DEXA);bone specific alkaline phosphate; procollagen tp‐1 N‐pro‐peptide;tp1 collagen cross‐linked c‐telopeptide;osteocalcin;fasting ionized calcium;25‐OH‐vitamin‐D;PTH; Leukocytes;hemoglobin;platelets;sodium;potassium;bilirubin;alanine aminotransferase Timepoint(s) of evaluation of this end point: 45 weeks