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Clinical Trials/NCT04903847
NCT04903847UnknownPhase 4

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

Thomas Benfield5 sites in 1 country126 target enrollmentStarted: February 2, 2021Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Sponsor
Enrollment
126
Locations
5
Primary Endpoint
Body weight

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

doravirine/tenofovir disproxil/lamivudine

Experimental

100 mg doravirin, 245 mg tenofovirdisoproxil and 300 mg lamivudine once daily for 48 weeks.

Intervention: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO] (Drug)

dolutegravir/lamivudine

Experimental

dolutegravir 50 mg/lamivudine 300 mg once daily for 48 weeks

Intervention: Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO] (Drug)

Outcomes

Primary Outcomes

Body weight

Time Frame: 48 Weeks

Primary outcome is a change in body weight of more than 2 kg from

Secondary Outcomes

  • Virological control(48 weeks)
  • Diabetic profile(48 weeks)
  • Cholesterol profile(48 weeks)
  • Fat distribution(48 weeks)
  • Hepatic elasticity(48 weeks)
  • Hepatic fat infiltration(48 weeks)
  • Body composition/perfiferal and central fat distribution(48 weeks)
  • Estimated Glomerular Filtration Rate (eGFR) (creatinine)(48 weeks)
  • Self-rated health(48 weeks)
  • Insulin resistance(48 weeks)
  • eGFR (cystatin)(48 weeks)
  • Urea(48 weeks)
  • Urine RBP/creatinine ratio(48 weeks)
  • Urine Beta-2-Microglobulin(B2M)/creatinine ratio(48 weeks)
  • Urine albumin/creatinine ratio(48 weeks)
  • Bone-specific alkaline phosphate(48 weeks)
  • Procollagen type 1 N-pro-peptide(48 weeks)
  • Type 1 collagen cross-linked C-telopeptide(48 weeks)
  • Osteocalcin(48 weeks)
  • Urine protein/creatinine ratio(48 weeks)
  • Urine phosphate(48 weeks)
  • Bone mass density (BMD)(48 weeks)
  • Fasting ionized calcium(48 weeks)
  • 25(OH)vitamin D vitamin D 25(OH)vitamin D(48 weeks)
  • Parathyroid hormone (PTH) vitamin D 25(OH)vitamin D(48 weeks)
  • Inflammation(48 weeks)

Investigators

Sponsor
Thomas Benfield
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Thomas Benfield

MD, professor, dr.med.

Hvidovre University Hospital

Study Sites (5)

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