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

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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