Study of Body Weight and BMI Changes in Men With HIV on Second-Generation Integrase Inhibitors Compared to Switching to Doravirine-Based Treatment Over 48 Weeks

What this Trial Is About

This research aims to evaluate changes in body weight and body mass index BMI among people with HIV PWH who have experienced metabolic syndrome after at least 36 months on antiretroviral therapy ART using second-generation integrase inhibitors. Participants must have gained at least 10% of their body weight after starting ART, with a BMI of 25 kgm2 or higher and body fat over 20%. The study focuses on whether switching to a different ART regimen affects weight and metabolic health over 48 weeks. Participants will be randomly assigned by a mobile application to either continue their current integrase inhibitor-based ART regimen or switch to a regimen containing doravirine, lamivudine, and tenofovir disoproxil fumarate DOR3TCTDF. Both treatment groups will take one tablet daily for 48 weeks. Medical visits will occur at 1, 3, 6, 9, and 12 months, with laboratory tests to monitor fats, blood sugar, liver and kidney function, and HIV control. Self-assessment scales for neuropsychiatric symptoms like depression, anxiety, and insomnia, as well as treatment satisfaction, will also be completed. Participants will undergo detailed medical interviews, physical measurements including body composition, and regular blood and urine tests throughout the study. Questionnaires will evaluate mental health and treatment satisfaction at multiple time points. The main outcome is the change in body weight and BMI after 48 weeks. Secondary outcomes include safety monitoring, neuropsychiatric effects, lipid profile changes, body composition, cardiovascular risk, and kidney function. Participants can withdraw at any time without affecting their usual HIV care.

Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI