Status:
COMPLETED
Changes in Weight, Body Composition and Cardiac Risk After Discontinuing Abacavir Treatment in HIV-infected Individuals
Lead Sponsor:
Thomas Benfield
Conditions:
Hiv
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Randomized controlled parallel open-label study in people living with HIV and at least 6 month of treatment with dolutegravir/abacavir/lamivudine prior to inclusion. Participants (n=95) are randomize...
Detailed Description
In the MRI sub study 40 patients from the main study (20 from each group) are included. A cardiac MRI are performed at baseline and week 48 to evaluate cardiac effects of abacavir.
Eligibility Criteria
Inclusion
- ≥ 18 years old
- Diagnosed HIV
- At least 6 months of ongoing treatment with dolutegravir/ abacavir/lamivudine
- Plasma viral load (HIV-RNA) \< 50 copies/ml at inclusion
- For women of childbearing potential:
- Negative pregnancy test
- Willingness to use contraceptive (consistent with local regulations) during study period
Exclusion
- Pre-existing viral resistance mutations to lamivudine or to dolutegravir
- Presence of hepatitis B antigen (HBsAg) or Hepatitis B virus DNA (HBV DNA)
- Cancer within past 5 years
- Diabetes, cardiovascular disease or other chronic illness considered stable as assessed by the treating physician
- For women of childbearing potential:
- Pregnancy
- Breastfeeding
Key Trial Info
Start Date :
October 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT04904406
Start Date
October 22 2020
End Date
December 1 2023
Last Update
May 29 2024
Active Locations (2)
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1
Copenhagen University Hospital - Rigshospitalet
Copenhagen, Denmark, 2100
2
Copenhagen University Hospital, Amager Hvidovre
Hvidovre, Denmark, 2650