Brief Title
Changes in Weight, Body Composition and Cardiac Risk After Discontinuing Abacavir Treatment in HIV-infected Individuals
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
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Changes in body weight of ≥2 kg
Secondary Outcome
Virological control
Condition
Hiv
Intervention
Dolutegravir / Lamivudine Oral Tablet
Study Arms / Comparison Groups
dolutegravir/lamivudine
Description: 50 mg dolutegravir and 300 mg lamivudine (co-formulated) once daily for 48 weeks
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
95
Start Date
October 22, 2020
Completion Date
December 1, 2022
Primary Completion Date
December 1, 2022
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Thomas Benfield, MD, DMSc, +4521623027, karen.brorup.heje.pede[email protected]
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT04904406
Organization ID
H-20011433
Responsible Party
Sponsor-Investigator
Study Sponsor
Thomas Benfield
Study Sponsor
Thomas Benfield, MD, DMSc, Principal Investigator, Department of Infectious diseases, Hvidovre Hospital, Denmark
Verification Date
May 2021