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Clinical Trials/EUCTR2020-000205-89-DK
EUCTR2020-000205-89-DK
Active, not recruiting
Phase 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 enrollmentFebruary 14, 2020
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DrugsVireadDelstrigoDovatoTenofovir disproxil SandozTenofovir disproxil StadaTenofovir disproxil TEVATenofovir disproxil Accordpharma

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Department of Infectious Diseases, Hvidovre Hospital
Enrollment
126
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 14, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Department of Infectious Diseases, Hvidovre Hospital

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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