Changes in Weight, Body Composition and Metabolic Parameters After Discontinuing Dolutegravir or Tenofovir Disproxil

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Brief Title

Changes in Weight, Body Composition and Metabolic Parameters After Discontinuing Dolutegravir or Tenofovir Disproxil

Official Title

Changes in Weight After Switch to Dolutegravir/Lamivudine or Doravirine/Tenofovir/Lamivudine Compared to Continued Treatment With Dolutegravir/Tenofovir/Lamivudine for Virologically Suppressed HIV Infection. AVERTAS-2

Brief Summary

      Randomized controlled parallel open-label study in persons living with HIV. The aim is to
      study weight changes in patients switching from a dolutegravir and tenofovir disoproxil
      containing regimen to either a dolutegravir or tenofovir disoproxil free regimen.
    

Detailed Description

      Randomized controlled parallel open-label study in persons living with HIV and at least 6
      month of treatment with dolutegravir/abacavir/lamivudine prior to inclusion.

      Participants (n=126) are randomized to continue 3 drug-regimen dolutegravir/tenofovir
      disoproxil/lamivudine (control) or switch to two-drug regimen with dolutegravir/lamivudine
      (intervention 1) or to three-drug regimen with doravirine/tenofovir disoproxil/lamivudine.
      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 virus persistent viral suppression, changes in body composition and
      metabolism, changes in bone metabolisme and renal function, changes in liver elasticity and
      fat infiltration.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Body weight

Secondary Outcome

 Virological control

Condition

Hiv

Intervention

Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO]

Study Arms / Comparison Groups

 Dolutegravir/tenofovir disproxil/lamivudine
Description:  Continue dolutegravir 50 mg, tenofovir disproxil 245 mg, ,and lamivudine 300 mg 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

126

Start Date

February 2, 2021

Completion Date

February 2, 2023

Primary Completion Date

February 2, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Individuals ≥ 18 years old with diagnosed HIV and at least 6 months of ongoing
             treatment with dolutegravir/ doravirin/lamivudine will be included. Patients must have
             a plasma viral load (HIV-RNA) < 50 copies/ml at inclusion. For women of childbearing
             potential: Negative pregnancy test and willingness to use contraceptive (consistent
             with local regulations) during study period

        Exclusion Criteria:

          -  Patients will be excluded in case of pre-existing viral resistance mutations to
             lamivudine, dolutegravir, tenofovir or doravirine the presence of hepatitis B antigen
             (HBsAg) or HBV DNA, cancer within past 5 years, pregnancy or breastfeeding. Any case
             of diabetes, cardiovascular disease or other chronic illness must be considered stable
             as assessed by the treating physician.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Thomas Benfield, MD, +4521623027, [email protected]

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT04903847

Organization ID

H-20012194


Responsible Party

Sponsor-Investigator

Study Sponsor

Thomas Benfield


Study Sponsor

Thomas Benfield, MD, Study Director, Center of Research and Disruption of Infectious Diseases


Verification Date

May 2021