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

  • STATUS
    Recruiting
  • End date
    Feb 2, 2023
  • participants needed
    126
  • sponsor
    Thomas Benfield
Updated on 4 June 2021
tenofovir
dolutegravir
lamivudine
treatment regimen
HIV Vaccine

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.

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.

Details
Condition Weight Gain, Renal Failure, Osteopenia, HIV, HIV positive, HIV infection, Nephropathy, Immunodeficiency, Osteoporosis, AIDS Vaccines, adiposity, Obesity, Renal Impairment, Renal Dysfunction, Impaired Renal Function, HIV Lipodystrophy, HIV Infections, Kidney Failure, kidney insufficiency, renal insufficiency, human immunodeficiency virus, hiv disease, HIV Vaccine, hiv vaccines
Treatment Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO], Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO]
Clinical Study IdentifierNCT04903847
SponsorThomas Benfield
Last Modified on4 June 2021

Eligibility

Yes No Not Sure

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
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