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在儿童艾滋病临床试验组方案076中,母亲的病毒基因型齐多夫定耐药性以及齐多夫定治疗在预防围产期人类免疫缺陷病毒1型传播方面的罕见失败情况。

Maternal viral genotypic zidovudine resistance and infrequent failure of zidovudine therapy to prevent perinatal transmission of human immunodeficiency virus type 1 in pediatric AIDS Clinical Trials Group Protocol 076.

作者信息

Eastman P S, Shapiro D E, Coombs R W, Frenkel L M, McSherry G D, Britto P, Herman S A, Sperling R S

机构信息

Chiron Corporation, Emeryville, California, USA.

出版信息

J Infect Dis. 1998 Mar;177(3):557-64. doi: 10.1086/514228.

DOI:10.1086/514228
PMID:9498432
Abstract

Maternal samples were assessed from 96 women enrolled in Pediatric AIDS Clinical Trials Group protocol 076 to determine the prevalence of human immunodeficiency virus type 1 (HIV-1) genotypic zidovudine resistance at entry, if zidovudine resistance developed on study, and the role of zidovudine resistance in vertical transmission of HIV-1 despite zidovudine therapy. Low and high levels of genotypic resistance were assessed by differential hybridization, oligoligation, or direct sequencing of plasma HIV-1 RNA for codons K70R and T215Y/F. None of the women had high-level genotypic resistance to zidovudine at study entry or delivery. For low-level zidovudine resistance, the 95% confidence intervals were 0.3%-6.8% for baseline prevalence and 0.3%-14% for delivery incidence. Low-level zidovudine resistance, adjusted for plasma viral RNA level at delivery, was not strongly associated with an increase in vertical transmission risk (odds ratio, 4.8; 95% confidence interval, 0.2-131; P = .35).

摘要

对参加儿童艾滋病临床试验组076号方案的96名女性的母体样本进行了评估,以确定入组时1型人类免疫缺陷病毒(HIV-1)基因型齐多夫定耐药性的流行情况、研究期间是否出现齐多夫定耐药性,以及尽管接受了齐多夫定治疗,齐多夫定耐药性在HIV-1垂直传播中的作用。通过对血浆HIV-1 RNA的密码子K70R和T215Y/F进行差异杂交、寡核苷酸连接或直接测序,评估基因型耐药性的低水平和高水平。在研究入组或分娩时,没有女性对齐多夫定具有高水平的基因型耐药性。对于低水平的齐多夫定耐药性,基线患病率的95%置信区间为0.3%-6.8%,分娩时发病率的95%置信区间为0.3%-14%。根据分娩时血浆病毒RNA水平进行调整后,低水平的齐多夫定耐药性与垂直传播风险增加没有密切关联(优势比为4.8;95%置信区间为0.2-131;P = 0.35)。

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