Effectiveness and Safety of Darunavir/Cobicistat Plus Lamivudine Compared With Darunavir/Cobicistat Plus Tenofovir Alafenamide/Emtricitabine in Virologically Suppressed People Living With HIV at 24 and 48 Weeks of Follow-up

Summary

A single-center, open-label, randomized pilot clinical trial between March 2025 and March 2026 at the Hospital de Infectología "La Raza" National Medical Center in Mexico City. Eligible participants were adult males (≥18 years) with HIV-1 infection who had maintained virological suppression (HIV-1 RNA \<50 copies/mL) for 48 weeks on either DRV/c + 3TC or DRV/c + TDF/FTC prior to enrollment (TLALOC-1 trial), and had an estimated glomerular filtration rate (eGFR) by CKD-EPI ≥60 mL/min/1.73 m². The primary endpoints were virological efficacy and safety at 24 weeks.

Timeline

Start

2025-07-10

Primary completion

2026-07-10

Completion

2026-12-10

Publications

• Results Osiyemi O, De Wit S, Ajana F, Bisshop F, Portilla J, Routy JP, Wyen C, Ait-Khaled M, Leone P, Pappa KA, Wang R, Wright J, George N, Wynne B, Aboud M, van Wyk J, Smith KY. Efficacy and Safety of Switching to Dolutegravir/Lamivudine Versus Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Results Through Week 144 From the Phase 3, Noninferiority TANGO Randomized Trial. Clin Infect Dis. 2022 Sep 29;75(6):975-986. doi: 10.1093/cid/ciac036.
• Results Perez-Molina JA, Rubio R, Rivero A, Pasquau J, Suarez-Lozano I, Riera M, Estebanez M, Palacios R, Sanz-Moreno J, Troya J, Marino A, Antela A, Navarro J, Esteban H, Moreno S; GeSIDA 7011 Study Group. Simplification to dual therapy (atazanavir/ritonavir + lamivudine) versus standard triple therapy [atazanavir/ritonavir + two nucleos(t)ides] in virologically stable patients on antiretroviral therapy: 96 week results from an open-label, non-inferiority, randomized clinical trial (SALT study). J Antimicrob Chemother. 2017 Jan;72(1):246-253. doi: 10.1093/jac/dkw379. Epub 2016 Sep 13.
• Results Van Vaerenbergh K. Study of the impact of HIV genotypic drug resistance testing on therapy efficacy. Verh K Acad Geneeskd Belg. 2001;63(5):447-73.
• Results Gibas KM, Kelly SG, Arribas JR, Cahn P, Orkin C, Daar ES, Sax PE, Taiwo BO. Two-drug regimens for HIV treatment. Lancet HIV. 2022 Dec;9(12):e868-e883. doi: 10.1016/S2352-3018(22)00249-1. Epub 2022 Oct 26.
• Results Hernandez-Jeronimo JH, Martinez-Rivera NC, Perez-Jimenez C, Volkow-Fernandez P, Martin-Onraet A. Multimorbidity in people living with HIV and cancer in Mexico. Gac Med Mex. 2024;160(2):144-153. doi: 10.24875/GMM.M24000888.
• Results Medina-Gomez OS, Barrios-Perez A, Sosa-Tapia A, Diaz-Munoz I. [HIV mortality trends in Mexico, 2000-2022]. Rev Med Inst Mex Seguro Soc. 2024 Nov 4;62(6):1-7. doi: 10.5281/zenodo.13306693. Spanish.
• Results Moroti Constantinescu VR. Acute Human Immunodeficiency Virus Infection. N Engl J Med. 2023 Dec 14;389(24):2276. doi: 10.1056/NEJMicm2306536. No abstract available.
• Results Fisher KA, Patel SV, Mehta N, Stewart A, Medley A, Dokubo EK, Shang JD, Wright J, Rodas J, Balachandra S, Kitenge F, Mpingulu M, Garcia MC, Bonilla L, Quaye S, Melchior M, Banchongphanith K, Phokhasawad K, Nkanaunena K, Maida A, Couto A, Mizela J, Ibrahim J, Charles OO, Malamba SS, Musoni C, Bolo A, Bunga S, Lolekha R, Kiatchanon W, Bhatia R, Nguyen C, Aberle-Grasse J; PEPFAR Strategic Information Study Group. Lessons Learned from Programmatic Gains in HIV Service Delivery During the COVID-19 Pandemic - 41 PEPFAR-Supported Countries, 2020. MMWR Morb Mortal Wkly Rep. 2022 Mar 25;71(12):447-452. doi: 10.15585/mmwr.mm7112a2.
• Results Kilmarx PH. Global epidemiology of HIV. Curr Opin HIV AIDS. 2009 Jul;4(4):240-6. doi: 10.1097/COH.0b013e32832c06db.
• Results Blackard JT, Cohen DE, Mayer KH. Human immunodeficiency virus superinfection and recombination: current state of knowledge and potential clinical consequences. Clin Infect Dis. 2002 Apr 15;34(8):1108-14. doi: 10.1086/339547. Epub 2002 Mar 15.

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Indications