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

Summary

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.

Timeline

Start

2024-08-14

Primary completion

2025-11-14

Completion

2025-11-14

Publications

• Background O'Halloran JA, Sahrmann J, Parra-Rodriguez L, Vo DT, Butler AM, Olsen MA, Powderly WG. Integrase Strand Transfer Inhibitors Are Associated With Incident Diabetes Mellitus in People With Human Immunodeficiency Virus. Clin Infect Dis. 2022 Dec 19;75(12):2060-2065. doi: 10.1093/cid/ciac355.
• Background Orkin C, Squires KE, Molina JM, Sax PE, Wong WW, Sussmann O, Kaplan R, Lupinacci L, Rodgers A, Xu X, Lin G, Kumar S, Sklar P, Nguyen BY, Hanna GJ, Hwang C, Martin EA; DRIVE-AHEAD Study Group. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate is Non-inferior to Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment-naive Adults With Human Immunodeficiency Virus-1 Infection: Week 48 Results of the DRIVE-AHEAD Trial. Clin Infect Dis. 2019 Feb 1;68(4):535-544. doi: 10.1093/cid/ciy540.
• Background Calza L, Giglia M, Colangeli V, Bon I, Vitale S, Viale P. Improvement in insulin sensitivity after switching from an integrase inhibitor-based regimen to doravirine/tenofovir disoproxil fumarate/lamivudine in people with significant weight gain. HIV Med. 2024 Aug;25(8):919-926. doi: 10.1111/hiv.13644. Epub 2024 Apr 3.
• Background Orkin C, Elion R, Thompson M, Rockstroh JK, Alvarez Bognar F, Xu ZJ, Hwang C, Sklar P, Martin EA. Changes in weight and BMI with first-line doravirine-based therapy. AIDS. 2021 Jan 1;35(1):91-99. doi: 10.1097/QAD.0000000000002725.
• Background Molina JM, Squires K, Sax PE, Cahn P, Lombaard J, DeJesus E, Lai MT, Xu X, Rodgers A, Lupinacci L, Kumar S, Sklar P, Nguyen BY, Hanna GJ, Hwang C; DRIVE-FORWARD Study Group. Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 48-week results of a randomised, double-blind, phase 3, non-inferiority trial. Lancet HIV. 2018 May;5(5):e211-e220. doi: 10.1016/S2352-3018(18)30021-3. Epub 2018 Mar 25.
• Background Bares SH, Wu X, Tassiopoulos K, Lake JE, Koletar SL, Kalayjian R, Erlandson KM. Weight Gain After Antiretroviral Therapy Initiation and Subsequent Risk of Metabolic and Cardiovascular Disease. Clin Infect Dis. 2024 Feb 17;78(2):395-401. doi: 10.1093/cid/ciad545.
• Background Sokhela S, Venter WDF, Bosch B, Woods J, McCann K, Akpomiemie G, Chandiwana N, Mashabane N, Tembo A, Simmons B, Lalla-Edward S, Siedner MJ, Sinxadi P, Hermans L, Fairlie L, Vos A, Abrams E, Manne-Goehler JM, Moorhouse M, Clayden P, Norris S, Qavi A, Chersich M, Masenya M, Arulappan N, Hill A. Final 192-Week Efficacy and Safety Results of the ADVANCE Trial, Comparing 3 First-line Antiretroviral Regimens. Open Forum Infect Dis. 2024 Jan 24;11(3):ofae007. doi: 10.1093/ofid/ofae007. eCollection 2024 Mar.
• Background Gadde KM, Martin CK, Berthoud HR, Heymsfield SB. Obesity: Pathophysiology and Management. J Am Coll Cardiol. 2018 Jan 2;71(1):69-84. doi: 10.1016/j.jacc.2017.11.011.
• Background Eckard AR, McComsey GA. Weight gain and integrase inhibitors. Curr Opin Infect Dis. 2020 Feb;33(1):10-19. doi: 10.1097/QCO.0000000000000616.
• Background Hogg RS, Eyawo O, Collins AB, Zhang W, Jabbari S, Hull MW, Lima VD, Ahmed T, Kendall CE, Althoff KN, Justice AC, Barrios R, Shoveller J, Montaner JSG; Comparative Outcomes And Service Utilization Trends (COAST) study. Health-adjusted life expectancy in HIV-positive and HIV-negative men and women in British Columbia, Canada: a population-based observational cohort study. Lancet HIV. 2017 Jun;4(6):e270-e276. doi: 10.1016/S2352-3018(17)30029-2. Epub 2017 Mar 3.
• Background Marcus JL, Leyden WA, Alexeeff SE, Anderson AN, Hechter RC, Hu H, Lam JO, Towner WJ, Yuan Q, Horberg MA, Silverberg MJ. Comparison of Overall and Comorbidity-Free Life Expectancy Between Insured Adults With and Without HIV Infection, 2000-2016. JAMA Netw Open. 2020 Jun 1;3(6):e207954. doi: 10.1001/jamanetworkopen.2020.7954.

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