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Completed

NCT Number: NCT04904406

Changes in Weight, Body Composition and Cardiac Risk After Discontinuing Abacavir Treatment in HIV-infected Individuals

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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Body Weight Body Weight Changes Cardiovascular Diseases Communicable Diseases Genital Diseases HIV Cardiomyopathy HIV Infections HIV Lipodystrophy Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Signs and Symptoms Slow Virus Diseases Urogenital Diseases Virus Diseases Weight Change, Body

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dolutegravir / Lamivudine Oral Tablet

Drug

Discontinuing abacavir by switching from three-drug regimen with dolutegravir/abacavir/lamivudine to two-drug regimen with dolutegravir/lamivudine

Other names: Dolutegravir/abacavir/lamivudine

Primary outcomes

  1. Changes in body weight of ≥2 kg

    Time frame: 48 weeks

    Fasting body weight

Secondary outcomes

  1. Virological control

    Time frame: 48 weeks

    HIV-RNA <50 copies/ml

  2. Changes in self-rated health

    Time frame: 48 weeks

    12-item Short Form Health Survey (SF-12). Scores from 0 (worse) to 100 (best).

  3. Change in metabolism

    Time frame: 48 weeks

    Impaired insulin resistance and/or β-cell function determined by changes in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

  4. Changes in cardiac risk

    Time frame: 48 weeks

    D:A:D CVD risk score: Five and ten years predicted cardio vascular disease risk (percent)

  5. Changes in carotid artery intima-media thickness (cIMT)

    Time frame: 48 weeks

    Measured by ultrasound.

  6. Changes in Coronary artery calcium score (CACS)

    Time frame: 48 weeks

    Measures by CT-scan. Scores from 0 and with no upper limit. The higher score, the worse calcification/plaque level and higher CVD risk.

  7. Changes in cardiac blood markers

    Time frame: 48 weeks

    Changes in N-terminal pro-B-type natriuretic peptide (Pro-BNP)

  8. Changes in bloodpressure

    Time frame: 48 weeks

    Systolic and diastolic blood pressure (mmHg)

  9. Changes in fat distribution VAT/SAT

    Time frame: 48 weeks

    Measured by CT-scan

    • Visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) determined by abdominal CT.

  10. Changes in liver stiffness

    Time frame: 48 weeks

    Measured by CT-scan and liver elastography

  11. Changes in liver fat infiltration

    Time frame: 48 weeks

    Measured by CT-scan and liver elastography

  12. Changes in fat distribution in trunk, limb and extremities

    Time frame: 48 weeks

    Measured by dual energy xray absorptiometry (DEXA)

  13. Changes in inflammation

    Time frame: 48 weeks

    High-sensitive C-reactive protein

  14. Changes in interleukins

    Time frame: 48 weeks

    Interleukin 1- and interleukin 6

  15. Changes in endothelial function

    Time frame: 48 weeks

    Vascular cell adhesion molecule 1 and intercellular adhesion molecule 1

  16. Changes in soluble P-selectin

    Time frame: 48 weeks

    soluble P-selectin

  17. Changes in soluble glycoprotein VI

    Time frame: 48 weeks

    soluble glycoprotein VI

  18. Changes in d-dimer

    Time frame: 48 weeks

    D-dimer

  19. Changes in coagulation

    Time frame: 48 weeks

    Factor 2, 7 and 10 (extrinsic pathway)

  20. Changes in fibrinogen

    Time frame: 48 weeks

    Fibrinogen

  21. Changes in blood Hemoglobin

    Time frame: 48 weeks

    Hemoglobin

  22. Changes in blood platelets

    Time frame: 48 weeks

    Platelets

  23. Changes in plasma creatinine

    Time frame: 48 weeks

    Creatinine

  24. Changes in plasma urea

    Time frame: 48 weeks

    Urea

  25. Changes in plasma sodium

    Time frame: 48 weeks

    Sodium

  26. Changes in plasma potassium

    Time frame: 48 weeks

    Potassium

  27. Changes in plasma bilirubin

    Time frame: 48 weeks

    Bilirubin

  28. Changes in plasma alanine

    Time frame: 48 weeks

    Alanine

  29. Changes in plasma aminotransferase

    Time frame: 48 weeks

    Aminotransferase

  30. Cardiovascular risk

    Time frame: 48 weeks

    Framingham risk score: Estimated 10 years risk of cardiovascular disease (percent)

  31. Cardiac biomarkers

    Time frame: 48 weeks

    Changes in Troponin T (TnT)

Other outcomes

  1. Cardiac MRI substudy primary outcome (composite) ECV

    Time frame: 48 weeks

    Cardiac MRI applied on 40 patients to evaluate:

    Decrease in extracellular myocardial volume (ECV) from baseline to week 48

  2. Cardiac MRI substudy primary outcome (composite) atrial volume

    Time frame: 48 weeks

    Cardiac MRI applied on 40 patients to evaluate:

    Decrease in left atrial volume from baseline to week 48

  3. Cardiac MRI substudy primary outcome (composite) diastolic function

    Time frame: 48 weeks

    Cardiac MRI applied on 40 patients to evaluate:

    Improvement in diastolic function from baseline to week 48

  4. Cardiac MRI substudy primary outcome (composite) myocardial mass

    Time frame: 48 weeks

    Cardiac MRI applied on 40 patients to evaluate:

    Reduction in myocardial mass from baseline to week 48

  5. Cardiac MRI substudy secondary outcome ejection fraction (EF)

    Time frame: 48 weeks

    Cardiac MRI applied on 40 patients to evaluate:

    Secondary outcomes

    Changes in:

    • Ejection fraction (EF)

  6. Cardiac MRI substudy secondary outcome perfusion

    Time frame: 48 weeks

    Cardiac MRI applied on 40 patients to evaluate:

    Secondary outcomes

    Changes in:

    • Perfusion

  7. Cardiac MRI substudy secondary outcome edema/inflammation

    Time frame: 48 weeks

    Cardiac MRI applied on 40 patients to evaluate:

    Secondary outcomes

    Changes in:

    • Edema/inflammation

  8. Cardiac MRI substudy secondary outcome fibrosis

    Time frame: 48 weeks

    Cardiac MRI applied on 40 patients to evaluate:

    Secondary outcomes

    Changes in:

    • Fibrosis

  9. Cardiac MRI substudy secondary outcome lipid

    Time frame: 48 weeks

    Cardiac MRI applied on 40 patients to evaluate:

    Secondary outcomes

    Changes in:

    • Lipid-water profile Measured by MR spectroscopy

Sponsors and collaborators

Lead sponsor

Thomas Benfield

Other

Registry information

Official study 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

Acronym: AVERTAS

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 27, 2021
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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