Triple vs. Double Therapy in naïves HIV-Infected Patients

Summary

The objective of this study is to clarify whether if starting antiretroviral treatment based on dual therapy (DTG + 3TC) could provide less control of residual HIV replication and, therefore, a detriment on immune activation and inflammation compared to starting with triple therapy, and could worsen the patients' long-term prognosis. For this purpose, the investigator has designed a randomized clinical trial where will assess the immunological recovery (CD4+/CD8+), immune activation, proliferation, senescence and apoptosis in T lymphocytes CD4+ and CD8+ cells by flow cytometry, the immune activation of monocytes/ macrophages and plasma concentrations of various inflammatory mediators by ELISAS, and the thymic function, the cellular reservoir of HIV and the degree of HIV DNA transcription by digital dropped PCR.

Timeline

Start

2020-03-10

Primary completion

2022-01

Completion

2023-03

Outcome

Missed primary endpoint

paper CONCLUSIONS: After 12 weeks of treatment, there were no differences in the percentage of undetectable SP HIV-1-RNA in naive PLWH who started dolutegravir/lamivudine compared with DTG + TAF/FTC. PMID 37545387 ↗

Publications

• Saborido-Alconchel A, Serna-Gallego A, Lopez-Cortes LE, Trujillo-Rodriguez M, Praena-Fernandez JM, Dominguez-Macias M, Lozano C, Munoz-Muela E, Espinosa N, Roca-Oporto C, Sotomayor C, Herrero M, Gutierrez-Valencia A, Lopez-Cortes LF. Decay kinetics of HIV-1-RNA in seminal plasma with dolutegravir/lamivudine versus dolutegravir plus emtricitabine/tenofovir alafenamide in treatment-naive people living with HIV. J Antimicrob Chemother. 2023 Sep 5;78(9):2354-2360. doi: 10.1093/jac/dkad245.

Drugs

Indications