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拉替拉韦强化治疗在接受抗逆转录病毒治疗、CD4+T 细胞反应不佳的 HIV 感染患者中的一项随机、对照试验。

A randomized, controlled trial of raltegravir intensification in antiretroviral-treated, HIV-infected patients with a suboptimal CD4+ T cell response.

机构信息

University of California, San Francisco, USA.

出版信息

J Infect Dis. 2011 Apr 1;203(7):960-8. doi: 10.1093/infdis/jiq138.

DOI:10.1093/infdis/jiq138
PMID:21402547
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3068029/
Abstract

BACKGROUND

Some human immunodeficiency virus (HIV)-infected individuals are not able to achieve a normal CD4(+) T cell count despite prolonged, treatment-mediated viral suppression. We conducted an intensification study to assess whether residual viral replication contributes to replenishment of the latent reservoir and whether mucosal HIV-specific T cell responses limit the reservoir size.

METHODS

Thirty treated subjects with CD4(+) T cell counts of <350 cells/mm(3) despite viral suppression for ≥ 1 year were randomized to add raltegravir (400 mg twice daily) or matching placebo for 24 weeks. The primary end points were the proportion of subjects with undetectable plasma viremia (determined using an ultrasensitive assay with a lower limit of detection of <.3 copy/mL) and a change in the percentage of CD38(+)HLA-DR(+)CD8(+) T cells in peripheral blood mononuclear cells (PBMCs).

RESULTS

The proportion of subjects with undetectable plasma viremia did not differ between the 2 groups (P = .42). Raltegravir intensification did not have a significant effect on immune activation or HIV-specific responses in PBMCs or gut-associated lymphoid tissue.

CONCLUSIONS

Low-level viremia is not likely to be a significant cause of suboptimal CD4(+) T cell gains during HIV treatment.

CLINICAL TRIALS REGISTRATION

NCT00631449.

摘要

背景

尽管经过长期的治疗介导的病毒抑制,一些人类免疫缺陷病毒(HIV)感染者仍然无法达到正常的 CD4(+)T 细胞计数。我们进行了一项强化研究,以评估残留病毒复制是否有助于补充潜伏库,以及黏膜 HIV 特异性 T 细胞反应是否限制了库的大小。

方法

30 名经治疗的患者,尽管病毒抑制时间超过 1 年,但 CD4(+)T 细胞计数仍<350 个细胞/mm(3),随机分为加用拉替拉韦(400 mg 每日两次)或匹配安慰剂 24 周。主要终点是检测不到血浆病毒血症的患者比例(使用具有<0.3 拷贝/ml 的检测下限的超灵敏检测法确定)和外周血单核细胞(PBMC)中 CD38(+)HLA-DR(+)CD8(+)T 细胞的百分比变化。

结果

两组患者中检测不到血浆病毒血症的患者比例无差异(P =.42)。拉替拉韦强化治疗对 PBMC 或肠道相关淋巴组织中的免疫激活或 HIV 特异性反应没有显著影响。

结论

低水平病毒血症不太可能是 HIV 治疗期间 CD4(+)T 细胞获得不佳的重要原因。

临床试验注册

NCT00631449。

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