Switching to Dolutegravir Plus Lamivudine Dual Therapy in Transgender Women Living with HIV on Stable Antiretroviral Treatment

What this Trial Is About

This research aims to assess the effectiveness and safety of a dual therapy combining dolutegravir and lamivudine as a switch strategy for transgender women living with HIV who are already on suppressive antiretroviral therapy. The study is a phase IV, open-label, single-arm trial involving 50 participants identifying as transgender women. It focuses on exploring how well this dual therapy works and how acceptable it is among this population. Participants will switch from their current antiretroviral regimen to a fixed-dose combination tablet containing 50 mg dolutegravir and 300 mg lamivudine taken orally once daily, with or without food. The treatment period lasts 48 weeks following a selection period of up to 30 days, and concludes with a 4-week post-treatment follow-up. No dose adjustments or changes in dosing frequency are permitted during the study. During the study, participants will be monitored through clinical evaluations, laboratory tests, and assessments of HIV viral load to measure virological efficacy at 48 weeks. Additional outcomes include safety evaluations, changes in immune cell counts, lipid profiles, kidney function, body weight, bone mineral density, resistance development, quality of life, treatment acceptance, and adherence. These measures will be collected at various time points throughout the 48-week treatment and follow-up period to provide a comprehensive understanding of the therapys impact.

Switch to Dolutegravir Plus Lamivudine Dual-Therapy in Transgender Women Living With HIV on Virologically Suppressive Antiretroviral Therapy (TRANS-SWITCH)