Trials / Unknown
UnknownNCT04903847
Changes in Weight, Body Composition and Metabolic Parameters After Discontinuing Dolutegravir or Tenofovir Disproxil
Changes in Weight After Switch to Dolutegravir/Lamivudine or Doravirine/Tenofovir/Lamivudine Compared to Continued Treatment With Dolutegravir/Tenofovir/Lamivudine for Virologically Suppressed HIV Infection. AVERTAS-2
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- Sponsor
- Thomas Benfield · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 either a dolutegravir or tenofovir disoproxil free regimen.
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 randomized to continue 3 drug-regimen dolutegravir/tenofovir disoproxil/lamivudine (control) or switch to two-drug regimen with dolutegravir/lamivudine (intervention 1) or to three-drug regimen with doravirine/tenofovir disoproxil/lamivudine. 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 virus persistent viral suppression, changes in body composition and metabolism, changes in bone metabolisme and renal function, changes in liver elasticity and fat infiltration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO] | Two-drug therapy |
| DRUG | Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO] | Three-drug therapy |
Timeline
- Start date
- 2021-02-02
- Primary completion
- 2023-02-02
- Completion
- 2023-02-02
- First posted
- 2021-05-27
- Last updated
- 2021-05-27
Locations
5 sites across 1 country: Denmark
Source: ClinicalTrials.gov record NCT04903847. Inclusion in this directory is not an endorsement.