Doravirine for Persons With Excessive Weight Gain on Integrase Inhibitors and Tenofovir Alafenamide
Status:
Recruiting
Trial end date:
2023-03-17
Target enrollment:
Participant gender:
Summary
The primary purpose of this study is to see if people with HIV who had a significant weight
gain after starting INSTI (integrase strand transfer inhibitor)+TAF/FTC (tenofovir
alafenamide/emtricitabine) (TAF/3TC (lamivudine)) regimen could either slow their rate of
weight gain or lose weight within about 1 year if they switch to a regimen containing
doravirine (DOR; a newer, non-nucleoside reverse transcriptase inhibitor medication). The
study will also try to see if participants changing from TAF/FTC (or TAF/3TC) to TDF/FTC (or
TDF/3TC) will experience less additional weight gain or a reduction in overall body weight at
48 weeks compared to persons continued on an INSTI + TAF/FTC (or TAF/3TC) combination.
INSTINs assessed in A5391 include bictegravir (BIC), dolutegravir (DTG), or raltegravir
(RAL). Additionally, the study will see whether a change in ART can affect things like waist
circumference, metabolic and cardiovascular health, fat and lean mass body composition, bone
health, and maintenance of virologic suppression. Finally, the study will look at the safety
and tolerability of DOR plus either TAF/FTC (or TAF/3TC) versus TDF/FTC (or TDF/3TC).
Phase:
Phase 4
Details
Lead Sponsor:
AIDS Clinical Trials Group
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)