Back to resultsChanges in Weight, Body Composition and Cardiac Risk After Discontinuing Abacavir Treatment in HIV-infected Individuals (AVERTAS-1)
Primary Purpose
Hiv, HIV Infections, HIV Cardiomyopathy
Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Dolutegravir / Lamivudine Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Hiv focused on measuring HIV, Weight changes, Antiretroviral Therapy, Cardiovascular disease, Antiretroviral therapy side effects, Antiretroviral two-drug regimen, HIV metabolism, HIV diabetes
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 years old
- Diagnosed HIV
- At least 6 months of ongoing treatment with dolutegravir/ abacavir/lamivudine
- Plasma viral load (HIV-RNA) < 50 copies/ml at inclusion
For women of childbearing potential:
- Negative pregnancy test
- Willingness to use contraceptive (consistent with local regulations) during study period
Exclusion Criteria:
- Pre-existing viral resistance mutations to lamivudine or to dolutegravir
- Presence of hepatitis B antigen (HBsAg) or Hepatitis B virus DNA (HBV DNA)
- Cancer within past 5 years
- Diabetes, cardiovascular disease or other chronic illness considered stable as assessed by the treating physician
For women of childbearing potential:
- Pregnancy
- Breastfeeding
Sites / Locations
- Aalborg University Hospital
- Aarhus University Hospital
- Rigshospitalet
- Copenhagen University Hospital, Amager HvidovreRecruiting
- Odense University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
dolutegravir/lamivudine
dolutegravir/abacavir/lamivudine
Arm Description
50 mg dolutegravir and 300 mg lamivudine (co-formulated) once daily for 48 weeks
50 mg dolutegravir, 600 mg abacavir and 300 mg lamivudine (co-formulated) once daily for 48 weeks
Outcomes
Primary Outcome Measures
Changes in body weight of ≥2 kg
Fasting body weight
Secondary Outcome Measures
Virological control
HIV-RNA <50 copies/ml
Changes in self-rated health
12-item Short Form Health Survey (SF-12). Scores from 0 (worse) to 100 (best).
Change in metabolism
Impaired insulin resistance and/or β-cell function determined by changes in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Changes in cardiac risk
D:A:D CVD risk score: Five and ten years predicted cardio vascular disease risk (percent)
Changes in carotid artery intima-media thickness (cIMT)
Measured by ultrasound.
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.
Changes in cardiac blood markers
Changes in N-terminal pro-B-type natriuretic peptide (Pro-BNP)
Changes in bloodpressure
Systolic and diastolic blood pressure (mmHg)
Changes in fat distribution VAT/SAT
Measured by CT-scan
• Visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) determined by abdominal CT.
Changes in liver stiffness
Measured by CT-scan and liver elastography
Changes in liver fat infiltration
Measured by CT-scan and liver elastography
Changes in fat distribution in trunk, limb and extremities
Measured by dual energy xray absorptiometry (DEXA)
Changes in inflammation
High-sensitive C-reactive protein
Changes in interleukins
Interleukin 1- and interleukin 6
Changes in endothelial function
Vascular cell adhesion molecule 1 and intercellular adhesion molecule 1
Changes in soluble P-selectin
soluble P-selectin
Changes in soluble glycoprotein VI
soluble glycoprotein VI
Changes in d-dimer
D-dimer
Changes in coagulation
Factor 2, 7 and 10 (extrinsic pathway)
Changes in fibrinogen
Fibrinogen
Changes in blood Hemoglobin
Hemoglobin
Changes in blood platelets
Platelets
Changes in plasma creatinine
Creatinine
Changes in plasma urea
Urea
Changes in plasma sodium
Sodium
Changes in plasma potassium
Potassium
Changes in plasma bilirubin
Bilirubin
Changes in plasma alanine
Alanine
Changes in plasma aminotransferase
Aminotransferase
Cardiovascular risk
Framingham risk score: Estimated 10 years risk of cardiovascular disease (percent)
Cardiac biomarkers
Changes in Troponin T (TnT)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04904406
Brief Title
Changes in Weight, Body Composition and Cardiac Risk After Discontinuing Abacavir Treatment in HIV-infected Individuals
Acronym
AVERTAS-1
Official Title
Changes in Weight and Body Composition After Switch to Dolutegravir/Lamivudine Compared to Continued Dolutegravir/Abacavir/Lamivudine for Virologically Suppressed HIV Infection: A Randomized Open-label Superiority Trial: AVERTAS-1
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 22, 2020 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas Benfield
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hiv, HIV Infections, HIV Cardiomyopathy, Weight Change, Body, HIV Lipodystrophy, Cardiovascular Diseases
Keywords
HIV, Weight changes, Antiretroviral Therapy, Cardiovascular disease, Antiretroviral therapy side effects, Antiretroviral two-drug regimen, HIV metabolism, HIV diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled open-label superiority trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
95 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dolutegravir/lamivudine
Arm Type
Experimental
Arm Description
50 mg dolutegravir and 300 mg lamivudine (co-formulated) once daily for 48 weeks
Arm Title
dolutegravir/abacavir/lamivudine
Arm Type
No Intervention
Arm Description
50 mg dolutegravir, 600 mg abacavir and 300 mg lamivudine (co-formulated) once daily for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Dolutegravir / Lamivudine Oral Tablet
Other Intervention Name(s)
Dolutegravir/abacavir/lamivudine
Intervention Description
Discontinuing abacavir by switching from three-drug regimen with dolutegravir/abacavir/lamivudine to two-drug regimen with dolutegravir/lamivudine
Primary Outcome Measure Information:
Title
Changes in body weight of ≥2 kg
Description
Fasting body weight
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Virological control
Description
HIV-RNA <50 copies/ml
Time Frame
48 weeks
Title
Changes in self-rated health
Description
12-item Short Form Health Survey (SF-12). Scores from 0 (worse) to 100 (best).
Time Frame
48 weeks
Title
Change in metabolism
Description
Impaired insulin resistance and/or β-cell function determined by changes in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time Frame
48 weeks
Title
Changes in cardiac risk
Description
D:A:D CVD risk score: Five and ten years predicted cardio vascular disease risk (percent)
Time Frame
48 weeks
Title
Changes in carotid artery intima-media thickness (cIMT)
Description
Measured by ultrasound.
Time Frame
48 weeks
Title
Changes in Coronary artery calcium score (CACS)
Description
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
Title
Changes in cardiac blood markers
Description
Changes in N-terminal pro-B-type natriuretic peptide (Pro-BNP)
Time Frame
48 weeks
Title
Changes in bloodpressure
Description
Systolic and diastolic blood pressure (mmHg)
Time Frame
48 weeks
Title
Changes in fat distribution VAT/SAT
Description
Measured by CT-scan
• Visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) determined by abdominal CT.
Time Frame
48 weeks
Title
Changes in liver stiffness
Description
Measured by CT-scan and liver elastography
Time Frame
48 weeks
Title
Changes in liver fat infiltration
Description
Measured by CT-scan and liver elastography
Time Frame
48 weeks
Title
Changes in fat distribution in trunk, limb and extremities
Description
Measured by dual energy xray absorptiometry (DEXA)
Time Frame
48 weeks
Title
Changes in inflammation
Description
High-sensitive C-reactive protein
Time Frame
48 weeks
Title
Changes in interleukins
Description
Interleukin 1- and interleukin 6
Time Frame
48 weeks
Title
Changes in endothelial function
Description
Vascular cell adhesion molecule 1 and intercellular adhesion molecule 1
Time Frame
48 weeks
Title
Changes in soluble P-selectin
Description
soluble P-selectin
Time Frame
48 weeks
Title
Changes in soluble glycoprotein VI
Description
soluble glycoprotein VI
Time Frame
48 weeks
Title
Changes in d-dimer
Description
D-dimer
Time Frame
48 weeks
Title
Changes in coagulation
Description
Factor 2, 7 and 10 (extrinsic pathway)
Time Frame
48 weeks
Title
Changes in fibrinogen
Description
Fibrinogen
Time Frame
48 weeks
Title
Changes in blood Hemoglobin
Description
Hemoglobin
Time Frame
48 weeks
Title
Changes in blood platelets
Description
Platelets
Time Frame
48 weeks
Title
Changes in plasma creatinine
Description
Creatinine
Time Frame
48 weeks
Title
Changes in plasma urea
Description
Urea
Time Frame
48 weeks
Title
Changes in plasma sodium
Description
Sodium
Time Frame
48 weeks
Title
Changes in plasma potassium
Description
Potassium
Time Frame
48 weeks
Title
Changes in plasma bilirubin
Description
Bilirubin
Time Frame
48 weeks
Title
Changes in plasma alanine
Description
Alanine
Time Frame
48 weeks
Title
Changes in plasma aminotransferase
Description
Aminotransferase
Time Frame
48 weeks
Title
Cardiovascular risk
Description
Framingham risk score: Estimated 10 years risk of cardiovascular disease (percent)
Time Frame
48 weeks
Title
Cardiac biomarkers
Description
Changes in Troponin T (TnT)
Time Frame
48 weeks
Other Pre-specified Outcome Measures:
Title
Cardiac MRI substudy primary outcome (composite) ECV
Description
Cardiac MRI applied on 40 patients to evaluate:
Decrease in extracellular myocardial volume (ECV) from baseline to week 48
Time Frame
48 weeks
Title
Cardiac MRI substudy primary outcome (composite) atrial volume
Description
Cardiac MRI applied on 40 patients to evaluate:
Decrease in left atrial volume from baseline to week 48
Time Frame
48 weeks
Title
Cardiac MRI substudy primary outcome (composite) diastolic function
Description
Cardiac MRI applied on 40 patients to evaluate:
Improvement in diastolic function from baseline to week 48
Time Frame
48 weeks
Title
Cardiac MRI substudy primary outcome (composite) myocardial mass
Description
Cardiac MRI applied on 40 patients to evaluate:
Reduction in myocardial mass from baseline to week 48
Time Frame
48 weeks
Title
Cardiac MRI substudy secondary outcome ejection fraction (EF)
Description
Cardiac MRI applied on 40 patients to evaluate:
Secondary outcomes
Changes in:
• Ejection fraction (EF)
Time Frame
48 weeks
Title
Cardiac MRI substudy secondary outcome perfusion
Description
Cardiac MRI applied on 40 patients to evaluate:
Secondary outcomes
Changes in:
• Perfusion
Time Frame
48 weeks
Title
Cardiac MRI substudy secondary outcome edema/inflammation
Description
Cardiac MRI applied on 40 patients to evaluate:
Secondary outcomes
Changes in:
• Edema/inflammation
Time Frame
48 weeks
Title
Cardiac MRI substudy secondary outcome fibrosis
Description
Cardiac MRI applied on 40 patients to evaluate:
Secondary outcomes
Changes in:
• Fibrosis
Time Frame
48 weeks
Title
Cardiac MRI substudy secondary outcome lipid
Description
Cardiac MRI applied on 40 patients to evaluate:
Secondary outcomes
Changes in:
• Lipid-water profile Measured by MR spectroscopy
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 18 years old
Diagnosed HIV
At least 6 months of ongoing treatment with dolutegravir/ abacavir/lamivudine
Plasma viral load (HIV-RNA) < 50 copies/ml at inclusion
For women of childbearing potential:
Negative pregnancy test
Willingness to use contraceptive (consistent with local regulations) during study period
Exclusion Criteria:
Pre-existing viral resistance mutations to lamivudine or to dolutegravir
Presence of hepatitis B antigen (HBsAg) or Hepatitis B virus DNA (HBV DNA)
Cancer within past 5 years
Diabetes, cardiovascular disease or other chronic illness considered stable as assessed by the treating physician
For women of childbearing potential:
Pregnancy
Breastfeeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen BH Pedersen, MD
Phone
+4521623027
Email
karen.brorup.heje.pedersen@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas L Benfield, MD, DMSc
Email
thomas.lars.benfield@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Benfield, MD, DMSc
Organizational Affiliation
Department of Infectious diseases, Hvidovre Hospital, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik Nielsen, MD, DMSc
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex L Laursen, MD, DMSc
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Gerstoft, MD, DMSc
Facility Name
Copenhagen University Hospital, Amager Hvidovre
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Benfield, MD
Phone
38622302
Email
thomas.lars.benfield@regionh.dk
First Name & Middle Initial & Last Name & Degree
Karen Brorup Pedersen, MD
Email
karen.brorup.heje.pedersen@regionh.dk
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isik S Johansen, MD, DMSc
12. IPD Sharing Statement
Plan to Share IPD
No
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Changes in Weight, Body Composition and Cardiac Risk After Discontinuing Abacavir Treatment in HIV-infected Individuals
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