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TREATMENT OF CHRONIC HEPATITIS B VIRUS INFECTION

TREATMENT OF CHRONIC HEPATITIS B VIRUS INFECTION
慢性乙型肝炎病毒感染的治疗
批准号:
6099005
负责人:
ADRIANA R MARQUES
金额:
$0.0万
依托单位国家:
美国
项目类别:
财政年份:
--
资助国家:
美国
项目状态:
未结题
起止时间:
至

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中文摘要
翻译
我们对宇宙的理解的最新进展 HBV的复制机制,以及开发有效的 作为临床有效的HIV抑制剂的核苷类似物 逆转录酶或疱疹病毒聚合酶已经打开了一个新的 在治疗慢性HBV感染中的作用。现在有一个 联合治疗的逻辑基础,因为明确需要 长期治疗以及药物 单药治疗会出现耐药菌株,但选择 药物联合收割机和他们应该在方案 就业仍然不确定。我们进行了初步研究 评估安全性并获得有关 α干扰素与泛昔洛韦组合的功效。在 在这项研究中,我们治疗了慢性HBV感染的患者, 既往干扰素α治疗失败,方案重叠 干扰素α和泛昔洛韦治疗共20周。这 研究现已结束。我们正处于计划的最后阶段, 多中心、双盲、安慰剂对照研究, 泛昔洛韦与拉米夫定的组合与单独的拉米夫定。 本研究的目的是确定安全性,耐受性, 药代动力学和联合治疗的初步疗效 共40例慢性HBV感染患者接受48周以上的治疗。 这项研究正在与NIAID合作开发 抗病毒协作研究小组。
英文摘要
Recent advances in our understanding of the replicative mechanism of HBV, and the development of potent nucleoside analogues as clinically effective inhibitors of the HIV reverse transcriptase or herpesvirus polymerases has opened a new era in the treatment of chronic HBV infection. There is now a logical basis for combination therapy, because of the clear need for prolonged treatment and the associated possibility that drug resistant strains will emerge with monotherapy, but the choice of agents to combine and the regimens in which they should be employed remain uncertain. We have performed a preliminary study to assess the safety and to obtain preliminary information on the efficacy of the combination of alpha interferon with famciclovir. In this study, we treated patients with chronic HBV infection who had failed previous interferon alfa therapy, with an overlapping regimen of interferon alfa and famciclovir therapy totaling 20 weeks. This study is now closed. We are in the final stages of planning a multicenter, double blind, placebo-controlled study comparing the combination of famciclovir with lamivudine with lamivudine alone. The objectives of this study are to determine the safety, tolerance, pharmacokinetics, and preliminary efficacy of combination therapy over 48 weeks in a total of 40 patients with chronic HBV infection. This study is being developed in collaboration with the NIAID Collaborative Antiviral Study Group.
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