NCT04904406CompletedPhase 4
Changes in Weight, Body Composition and Cardiac Risk After Discontinuing Abacavir Treatment in HIV-infected Individuals
Changes in Weight and Body Composition After Switch to Dolutegravir/Lamivudine Compared to Continued Dolutegravir/Abacavir/Lamivudine for Virologically Suppressed HIV Infection: A Randomized Open-label Superiority Trial: AVERTAS-1
Source: ClinicalTrials.gov · Last updated 29 May 2024
Brief summary (registry, in English)
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 randomized to continue 3 drug-regimen dolutegravir/abacavir/lamivudine (control) or switch to two-drug regimen with dolutegravir/lamivudine (intervention). 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 changes in cardiac risk, composition and calcification of the heart tissue, and changes in body composition and metabolism, inflammation and coagulation. A MRI substudy is applied to focus on the cardiac adverse effects of abacavir.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 81 (actual)
- First submitted
- 9 Oct 2020
- Start date
- 22 Oct 2020
- Primary completion date
- 1 Dec 2023
- Lead sponsor
- Thomas Benfield
- Diseases
- HIV
- NCT number
- NCT04904406
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 81
- From 22 Oct 2020 to the primary completion date, 1 Dec 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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:
Other
- Pre-existing viral resistance mutations to lamivudine or to dolutegravir
- Pregnancy
- Breastfeeding
Who the study is looking for
- ≥ 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Copenhagen University Hospital, Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Copenhagen University Hospital - Amager-Hvidovre Coordinator of this site? Confirm its status | Hvidovre | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.