Changes in weight, body composition and metabolic parameters in HIV infected patients after switch from 2- to 3-drug treatment

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. The AVERTAS-2 trial.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000205-89-DK

Enrollment

126

Registered

2020-02-14

Start date

2020-06-16

Completion date

Unknown

Last updated

2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human immunodeficiency virus (HIV) MedDRA version: 21.1 Level: PT Classification code 10067326 Term: Antiretroviral therapy System Organ Class: 10042613 - Surgical and medical procedures

Interventions

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 nu

Eligibility

Sex/Gender

All

Inclusion criteria

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) =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Pre-existing viral resistance mutations to lamivudine, dolutegravir, tenofovir or doravirine - History of or positive hepatitis B antigen (HBsAg) test - Cancer within the 5 past years - Pregnancy or breastfeeding - Any case of diabetes or cardiovascular disease must be stable assessed by the treating physician

Design outcomes

Primary

Measure	Time frame
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.;Secondary Objective: Not applicable;Primary end point(s): Changes in body weight of more than 2 kg from baseline to week 48.;Timepoint(s) of evaluation of this end point: 48 weeks	—

Measure

Time frame

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.;Secondary Objective: Not applicable;Primary end point(s): Changes in body weight of more than 2 kg from baseline to week 48.;Timepoint(s) of evaluation of this end point: 48 weeks

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Denmark

Contacts

Public ContactKaren Brorup Heje Pedersen

Department of Infectious Diseases, Hvidovre Hospital

karen.brorup.heje.pedersen@regionh.dk+4538626061

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026