The Effect on Lipid Profile of Switching to Delstrigo in HIV Positive Patients
Status:
Not yet recruiting
Trial end date:
2024-07-01
Target enrollment:
Participant gender:
Summary
This is an open label, randomised, two-arm switch study over 48 weeks in which virally
suppressed participants on a stable combined ART regimen will be randomised (1:1) to an
immediate switch to 3TC/TDF/DOR (immediate switch arm, N=30) for the duration of the 48-week
study, or to maintaining their current cART followed by a switch to 3TC/TDF/DOR from week
24-48 (delayed switch arm, N=30). Participants will be monitored for the length of the study
(48 weeks) plus a 30-day follow-up period.
If patients withdraw or are withdrawn from the study treatment prematurely, an early
termination visit (ETV) should occur within 30 days post withdrawal.
The hypothesis of the study is that a switch to Delstrigo, which is a combination of
tenofovir disoproxil, lamivudine and doravirine (TDF/3TC/DOR) has a favourable impact on
lipid metabolism, glucose, weight, body composition and hepatic steatosis.