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Clinical Trials/EUCTR2020-000205-89-DK
EUCTR2020-000205-89-DKActive, not recruitingPhase 1

Changes in weight, body composition and metabolic parameters after switch to either dolutegravir/lamivudine or doravirine/tenofovir/lamivudine compared to continued treatment with dolutegravir/tenofovir/lamivudine for virologically suppressed HIV infection: A randomized open-label superiority trial. The AVERTAS-2 trial.

Department of Infectious Diseases, Hvidovre Hospital0 sites126 target enrollmentStarted: February 14, 2020Last updated:
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
126

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • - Individuals >18 years
  • - Diagnosed HIV
  • - At least 6 months of ongoing treatment with dolutegravir/ tenofovirdisproxil/lamivudin prior to inclusion
  • - Plasma viral load (HIV-RNA) < 50 copies/ml
  • - Women of reproductive potential will be included if using approved contraception.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 126
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • - Pre-existing viral resistance mutations to lamivudine, dolutegravir, tenofovir or doravirine
  • - History of or positive hepatitis B antigen (HBsAg) test
  • - Cancer within the 5 past years
  • - Pregnancy or breastfeeding
  • - Any case of diabetes or cardiovascular disease must be stable assessed by the treating physician

Investigators

Sponsor
Department of Infectious Diseases, Hvidovre Hospital

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