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

Patients who developed metabolic syndrome after initiation of HIV treatment or with antiretroviral therapy (ART) for at least 36 months, treated with second generation integrase inhibitors (BIC/TAF/FTC, DTG/ABC/3Tc or DTG+TDF/FTC) who have gained at least 10% of their total body weight after starting ART, with a body mass index ≥25 kg/m2 and body fat greater than 20% will be eligible to participate in this clinical trial. If they decide to participate, they will sign an informed consent. After this, a mobile application will randomly decide whether the participant will continue with their ART regimen or switch to another ART (listed in the guidelines as one of the main lines of treatment) containing doravirine/lamivudine/disoproxil fumarate tenofovir. Medical visits will be at 1 month, 3 months, 6 months, 9 months, and 12 months after get in to this protocol, with laboratory studies that evaluate fats, blood sugar, liver function, kidney function, and test for HIV control; in addition, each visit will be given self-fillable scales to evaluate neuropsychiatric disorders such as depression, anxiety, insomnia, satisfaction with treatment or symptoms associated with it.The aim of the study is to observe whether there is weight loss with the change in HIV treatment.

NCT Number	NCT06602622
Lead Sponsor	Instituto Mexicano del Seguro Social
Conditions	HIV, HIV Associate Weight Loss, HIV-1 Infection, Integrase Inhibitors, HIV; HIV PROTEASE INHIB, Weight Change, Weight Loss
Enrollment	108 participants
Start Date	2024-08-14
Primary Completion	2025-11-14 (estimated)
Study Completion	2025-11-14 (estimated)
Updated on ClinicalTrials.gov	2024-09-19