ClinicalTrials.Veeva

Menu

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

T

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)

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

Trial contacts and locations

2

Loading...

Central trial contact

Karen BH Pedersen, MD; Thomas L Benfield, MD, DMSc

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems