UNASSIGNED: Cross-sectional study in which HIV-1 treatment-naïve people started and maintained an InSTI-based 3DR or, at different times, switched to 2DR (dolutegravir or darunavir/cobicistat + lamivudine). CD4+ and CD8+ T-cell activation and exhaustion, plasma concentrations of hs-CRP, D-dimer, P-selectin, IL-1β, IL-6, TNF-α, IFN-γ, IP-10, sTNFR-I/II, MIP-1α/β, I-FABP, LBP, sCD14, sCD163, MCP-1, and cellular-associated HIV-1-DNA and -RNA were quantified by flow cytometry, different immunoassays, and droplet digital PCR, respectively. The U de Mann-Whitney test evaluated differences between 3DR and 2DR. Immune recovery was evaluated using a general linear model for repeated measures adjusted for different co-variables.
UNASSIGNED: Fifty participants per group were included. The median time on 3DR was 82 months for the 3DR group and 30 months for the 2DR group, after which it switched to 2DR for a median of 57 months. We did not find differences between both groups in any of the parameters analyzed. Specifically, some values in 3DR and 2DR were hs-CRP, 0.92 mg/L (0.45-2.23) vs. 1.23 (0.61-2.38); D-dimer, 190.0 µg/L (150.0-370.0) vs. 190.0 (150.0-397.5); IL-6, 2.8 pg/mL (1.3-5.3) vs. 3.2 (2.1-4.7); sCD14, 4.5 ng/mL (3.3-6.2) vs. 5.0 (3.6-6.1), respectively, all p ≥ 0.399.
UNASSIGNED: In the long term, switching to 2DR does not negatively affect immunologic parameters, inflammatory markers, or HIV-1 reservoir.
UNASSIGNED: identifier NCT04076423.
■横断面研究,其中未接受HIV-1治疗的人开始并维持基于InSTI的3DR或,在不同的时间,切换到2DR(dolutegravir或darunavir/cobicistat+拉米夫定)。CD4+和CD8+T细胞激活和耗尽,血浆hs-CRP浓度,D-二聚体,P-选择素,IL-1β,IL-6,TNF-α,IFN-γ,IP-10,sTNFR-I/II,MIP-1α/β,I-FABP,LBP,通过流式细胞术对sCD14、sCD163、MCP-1和细胞相关的HIV-1-DNA和-RNA进行定量,不同的免疫测定,和液滴数字PCR,分别。UdeMann-Whitney检验评估了3DR和2DR之间的差异。使用针对不同共变量调整的重复测量的一般线性模型评估免疫恢复。
■每组50名参与者。3DR组的中位时间为82个月,2DR组为30个月。之后,它转换为2DR,中位数为57个月。我们在分析的任何参数中都没有发现两组之间的差异。具体来说,3DR和2DR中的一些值是hs-CRP,0.92mg/L(0.45-2.23)vs.1.23(0.61-2.38);D-二聚体,190.0µg/L(150.0-370.0)与190.0(150.0-397.5);IL-6,2.8pg/mL(1.3-5.3)与3.2(2.1-4.7);sCD14,4.5ng/mL(3.3-6.2)与5.0(3.6-6.1),分别,所有p≥0.399。
■从长远来看,切换到2DR不会对免疫学参数产生负面影响,炎症标志物,或HIV-1水库。
■标识符NCT04076423。