Novel Therapies for Herpes Simplex Virus Infections

1.这个项目目前的主要重点是 随机、多中心、双盲、安慰剂对照的第三阶段 万乃洛韦预防慢性阻塞性肺疾病疗效的研究 单纯疱疹病毒(HSV)在异性伴侣中的传播 与单纯疱疹病毒2型(HSV-2)的存在不符 抗体。血清阳性的来源伙伴被随机接受 万乃洛韦500毫克，每日一次或安慰剂，疗程8个月 对易患血清阴性的伴侣进行临床和 HSV亚临床(血清学)获得性感染。总共1500个 夫妇将在大约35岁时随机进入这项研究 美国、加拿大和欧洲的门诊中心。这 这项研究是开放的，在这一点上，18名患者已经 在国立卫生研究院进行了筛查以接受治疗。2.单纯疱疹病毒863是人 抗单纯疱疹病毒的单抗。在体外和在 体内研究表明，HSV 863在预防和预防两方面都是有效的 并在治疗上对抗单纯疱疹病毒。一秒钟内 目前正在设计的研究，我们计划评估安全性，有效性和 单纯疱疹病毒863制剂在成人体内的药代动力学 在被测试为新生儿疱疹的辅助治疗之前。本研究 将在婴儿中进行HSV 863的I/II期研究 脑炎和播散性新生儿单纯疱疹病毒感染进一步 确定在III期对照试验中使用的剂量 新生儿单纯疱疹病毒感染。在这最初的几个月里 这个项目，制定了临床研究方案，并 生物资源公司正在生产单抗 弗雷德里克国家癌症研究所的分支机构， 马里兰州。

1. The major current focus of this project is a randomized, multicenter, double-blind, placebo-controlled Phase III study to evaluate the effect of valaciclovir in preventing the transmission of herpes simplex virus (HSV) in heterosexual couples discordant for the presence of herpes simplex type 2 virus (HSV-2) antibody. The seropositive source partner is randomized to receive valaciclovir 500 mg once daily or placebo for 8 months, and the susceptible seronegative partner is monitored for clinical and subclinical (serological) acquisition of HSV. A total of 1500 couples will be randomized into the study, at approximately 35 outpatient centers in the United States, Canada and Europe. This study is open for accrual and at this point, 18 patients have been screened for treatment at the NIH site. 2. HSV 863 is a human monoclonal antibody against herpes simplex virus. In vitro and in vivo studies showed that HSV 863 is effective both prophylactically and therapeutically against herpes simplex viruses. In a second study being designed now, we plan to assess the safety, potency and pharmacokinetics of HSV 863 preparation in an adult population before it is tested as adjunct therapy for neonatal herpes. This study will be followed by a phase I/II study of HSV 863 in babies with encephalitis and disseminated neonatal HSV infection to further determine the dose to be used in a phase III controlled trial for babies with neonatal HSV infection. During these initial months of this project, the clinical research protocol was developed and the monoclonal antibody is being produced at the Biological Resources Branch at the National Cancer Institute facility in Frederick, Maryland.