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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:

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中文摘要
翻译
我们对这个问题的理解的最新进展 HBV 的复制机制和有效的开发 核苷类似物作为临床上有效的 HIV 抑制剂 逆转录酶或疱疹病毒聚合酶开辟了新的途径 治疗慢性乙型肝炎病毒感染的时代到来了。现在有一个 联合治疗的逻辑基础,因为明确需要 延长治疗时间以及药物的相关可能性 单一疗法会出现耐药菌株,但选择 联合使用的药物以及它们应采用的治疗方案 就业仍不确定。我们进行了初步研究 评估安全性并获得初步信息 α干扰素与泛昔洛韦联合的功效。在 在这项研究中,我们治疗了患有慢性乙型肝炎病毒感染的患者 先前的干扰素α治疗失败,且治疗方案重叠 干扰素α和泛昔洛韦治疗总计20周。这个 研究现已结束。我们正处于规划的最后阶段 多中心、双盲、安慰剂对照研究比较 泛昔洛韦与拉米夫定的组合以及单独的拉米夫定。 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 对总共 40 名慢性 HBV 感染患者进行了超过 48 周的研究。 这项研究是与 NIAID 合作开发的 抗病毒合作研究小组。
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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