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

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

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.

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.

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