Evaluating if an Antiretroviral Therapy Medication Change Can Effect Weight
Official Title
“Doravirine for Persons with Excessive Weight Gain on Integrase Inhibitors and Tenofovir Alafenamide (The Do IT Study)”Purpose
The purpose of this study is to see whether people living with HIV who gained a significant amount of weight after starting an antiretroviral therapy (ART) could gain less weight, or might lose weight, after an ART regimen switch. The study will also look at whether a switch in antiretroviral therapy leads to differences in how the body stores and uses energy, heart and blood vessel health, and bone health. The study will last for 48 weeks (about 1 year). Following the first visit, you will need to come back to the clinic after about 4, 12, 24, 36, and 48 weeks. Each visit may take up to 3 hours.
Could this study be right for you?
• Living with HIV-1 • Be 18 years or older • Currently on an Integrase Inhibitor (INSTI) containing regimen (BIC, DTG or RAL), with > 48 weeks INSTI+TAF/FTC (or TAF/3TC) dosing prior to study entry • Have experienced more than 10% weight gain in the 1-3 years after starting these medications • Have a body mass index (BMI) >27.5 kg/m2 • Have study related tests done • Agree to use contraception/birth control methods if capable of becoming pregnant