Status:
UNKNOWN
Changes in Weight, Body Composition and Metabolic Parameters After Discontinuing Dolutegravir or Tenofovir Disproxil
Lead Sponsor:
Thomas Benfield
Conditions:
Hiv
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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 randomi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 2 2023
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT04903847
Start Date
February 2 2021
End Date
February 2 2023
Last Update
May 27 2021
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Infectious Diseases, Aalborg University Hospital
Aalborg, Denmark, 9000
2
Department of Infectious Diseases, Aarhus University Hospital
Aarhus, Denmark, 8200
3
Department of Infectious Diseases, Rigshospitalet
Copenhagen, Denmark, 2100
4
Department of Infectious Diseases, Hvidovre University Hospital
Hvidovre, Denmark, 2650