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在 MONOI-ANRS136 试验中,在 96 周的时间内,达芦那韦/利托那韦单药治疗与三联治疗的细胞 HIV-1 DNA 水平具有相似的演变。

Similar evolution of cellular HIV-1 DNA level in darunavir/ritonavir monotherapy versus triple therapy in MONOI-ANRS136 trial over 96 weeks.

机构信息

AP-HP, Pitié-Salpêtrière Hospital, INSERM U 943 and Pierre et Marie Curie University Paris, Paris, France.

出版信息

PLoS One. 2012;7(7):e41390. doi: 10.1371/journal.pone.0041390. Epub 2012 Jul 25.

Abstract

BACKGROUND

A higher proportion of intermittent viremia (to have a HIV-1 RNA viral load>50 copies/mL not confirmed) was reported in the boosted protease inhibitor monotherapy arm in some studies including MONOI trial, and that could have an impact on the replenishment of the HIV-1 DNA reservoirs. The HIV-1 DNA level is an interesting marker which reflects the size of cellular HIV reservoir. Our objectives were to study the impact of 96 weeks of Darunavir/ritonavir monotherapy versus a triple standard combination on the HIV-1 blood reservoir and factors associated with HIV-1 plasma DNA at baseline in MONOI trial sub-study.

METHODOLOGY/PRINCIPAL FINDINGS: This sub-study is focused on 160 patients (79 patients in monotherapy arm and 81 in tritherapy arm) for whom blood cells were available both at baseline and at week 96 (W96). Baseline HIV-1 plasma DNA was associated with CD4 nadir, pre therapeutic HIV-1 RNA viral load and baseline HIV-1 RNA measured by ultrasensitive assay. A similar median delta HIV-DNA was observed between D0 and W96 in both arms; 0.35 log copies/10(6) leucocytes in monotherapy arm versus 0.51 log copies/10(6) leucocytes in tritherapy arm.

CONCLUSION/SIGNIFICANCE: Despite a higher proportion of intermittent viremia in monotherapy arm, a similar evolution of cellular HIV-1 DNA level was observed between mono and triple therapy arm.

TRIAL REGISTRATION

ClinicalTrials. gov NCT00421551.

摘要

背景

在一些研究中,包括 MONOI 试验,与强化蛋白酶抑制剂单药治疗组相比,间歇性病毒血症(HIV-1 RNA 病毒载量>50 拷贝/毫升未确认)的比例较高,这可能会对 HIV-1 DNA 储库的补充产生影响。HIV-1 DNA 水平是一个反映细胞 HIV 储库大小的有趣标志物。我们的目的是研究 96 周的达芦那韦/利托那韦单药治疗与三药标准联合治疗对 MONOI 试验亚研究中 HIV-1 血液储库的影响,以及基线时与 HIV-1 血浆 DNA 相关的因素。

方法/主要发现:本亚研究主要关注 160 名患者(单药治疗组 79 名,三药治疗组 81 名),这些患者在基线和第 96 周(W96)均有血细胞可用。基线 HIV-1 血浆 DNA 与 CD4 最低点、治疗前 HIV-1 RNA 病毒载量和超敏检测法测量的基线 HIV-1 RNA 相关。在单药治疗组和三药治疗组中,从 D0 到 W96 观察到的 HIV-DNA 中位数变化相似;单药治疗组为 0.35 对数拷贝/10(6)白细胞,三药治疗组为 0.51 对数拷贝/10(6)白细胞。

结论/意义:尽管单药治疗组间歇性病毒血症的比例较高,但单药和三药治疗组之间观察到细胞 HIV-1 DNA 水平的相似变化。

试验注册

ClinicalTrials.gov NCT00421551。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eb34/3405120/3dfe49230d5d/pone.0041390.g001.jpg

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