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

Thomas Benfield

Status and phase: Completed; Phase 4

Conditions: HIV Cardiomyopathy; HIV Lipodystrophy; Cardiovascular Diseases; HIV Infections; Hiv; Weight Change, Body

Treatments: Drug: Dolutegravir / Lamivudine Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04904406

H-20011433

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

dolutegravir/lamivudine

Experimental group

Description:

50 mg dolutegravir and 300 mg lamivudine (co-formulated) once daily for 48 weeks

Treatment:

Drug: Dolutegravir / Lamivudine Oral Tablet

dolutegravir/abacavir/lamivudine

No Intervention group

Description:

50 mg dolutegravir, 600 mg abacavir and 300 mg lamivudine (co-formulated) once daily for 48 weeks