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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Randomize to naive-treatment HIV-infected patients to receive dual o triple therapy as initial antiretroviral treatment
Hospital Universitario Virgen del Rocio
Seville, Spain
RECRUITINGproviral HIV-DNA
Mean changes in proviral HIV-DNA in PBMCs after 48 and 96 weeks of treatment
Time frame: 48 and 96 weeks
Immune Recovery
Mean changes immune recovery assessed by CD4+/CD8+ T cell ratio.
Time frame: 48 and 96 weeks
Immune Activation
Mean changes immune activation assessed by the expression of HLA-DR and CD38 in both of CD4+ and CD8+ T cells.
Time frame: 48 and 96 weeks
Monocytes Activation
Mean changes monocytes activation (plasma sCD14 and sCD163).
Time frame: 48 and 96 weeks
Immunosenescense
Mean changes expression of markers for recent thymic emigrants (CD31), proliferation (Ki67), dysfunction (PD-1), senescence (CD57), and apoptosis (annexin A) in both CD4+ and CD8+ T cells.
Time frame: 48 and 96 weeks
Inflammation
Mean changes concentration of pro-inflammatory soluble mediator in plasma: TNF-α, IL-1β, IL-6, IP-10, IFN- γ, MIP-1α, MIP-1β, hsPCR y D-dímers.
Time frame: 48 and 96 weeks
Viral Reservoir
Mean changes viral reservoir size, evaluated by proviral HIV-DNA and HIV-RNA in peripheral blood mononuclear cells (PBMC) and CD4+ T cells isolate.
Time frame: 48 and 96 weeks
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