VALACYCLOVIR THERAPY OF SHINGLES IN IMMUNOCOMPROMISED PATIENTS
VALACYCLOVIR THERAPY OF SHINGLES IN IMMUNOCOMPROMISED PATIENTS
批准号:
6566714
负责人:
STEPHEN K TYRING
金额:
$27.93万
依托单位国家:
美国
项目类别:
财政年份:
2001
资助国家:
美国
项目状态:
已结题
起止时间:
2001-12-01 至 2002-11-30
关键词:
acyclovir adult human (21+) blood chemistry chronic pain clinical research clinical trial phase I drug adverse effect drug screening /evaluation human subject human therapy evaluation immunosuppression longitudinal human study medical complication microorganism disease chemotherapy oral administration pharmacokinetics prodrugs quality of life questionnaires self help sensory discrimination shingles valacyclovir
中文摘要
万乃洛韦可安全有效地治疗18岁及以上免疫受损患者的局限性带状疱疹。这是一项随机、双盲、对照试验,比较了两种剂量的口服盐酸万乃洛韦对18岁及以上免疫功能低下的带状疱疹患者的疗效和安全性。为了让两个治疗组各有25名患者完成治疗和随访,66名患者将平均随机分为这两个治疗组各一组。必须在带状疱疹发病后72小时内给予第一剂(第1天)研究药物。患者将接受1000毫克或2000毫克的万乃洛韦,每天三次,共7天。这些药物将以口服方式服用。患者的参与时间总共为24周。患者将在第1天、第3天、第6天、第8天、第10天、第14天、第21天和第28天接受带状疱疹相关疼痛和/或异常感觉和带状疱疹并发症的检查和评估,然后每4周检查一次,直至第24周(包括第24周)。在研究期间,将定期收集对资源使用和生活质量问题的答复。安全性将通过常规的血液学和生化评估以及不良经历的报告来监测。
英文摘要
Valacyclovir is safe and effective for treatment of localized herpes zoster in immunocompromised patients 18 years of age and older. This is a randomized, double-blind, controlled trial comparing the efficacy and safety of two doses of oral valacyclovir HCl for the treatment of uncomplicated herpes zoster in immunocompromised patients 18 years of age and older. In order that 25 patients complete therapy and follow-up in each of the two treatment groups, 66 patients will be equally randomized to each of these two treatment groups. Administration of the first dose(day 1) of study drug must occur within 72 hours of zoster rash onset. Patients will receive 1000 mg or 2000 mg valacyclovir three times daily for 7 days. These drugs will be taken orally. Patients' participation will be for a total of 24 weeks. Patients will be seen and assessed for zoster-associated pain and/or abnormal sensations and zoster complications on days 1,3,6,8,10,14,21, and 28 and then every 4 weeks up to and including week 24. Responses to resource use and quality of life questions will be collected at intervals during the study. Safety will be monitored by means of routine hematological and biochemical assessments and reporting of adverse experiences.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
Genetic Resistance to Oncogenic Human Papillomaviruses
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批准号:6920326
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项目类别:
-
资助金额:$6.99万
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财政年份:2003
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负责人:STEPHEN K TYRING
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依托单位:
Genetic Resistance to Oncogenic Human Papillomaviruses
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批准号:6601770
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项目类别:
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资助金额:$7.11万
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财政年份:2003
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负责人:STEPHEN K TYRING
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依托单位:
ABT 606 VS ACYCLOVIR FOR TREATMENT OF HERPES ZOSTER
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批准号:6566691
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项目类别:
-
资助金额:$27.93万
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财政年份:2001
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负责人:STEPHEN K TYRING
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依托单位:
STUDY OF ORAL LOBUCAVIR IN PATIENTS WITH RECURRENT GENITAL HERPES
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批准号:6566712
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项目类别:
-
资助金额:$27.93万
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财政年份:2001
-
负责人:STEPHEN K TYRING
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依托单位:
VALACYCLOVIR THERAPY OF SHINGLES IN IMMUNOCOMPETENT PATIENTS
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批准号:6566713
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项目类别:
-
资助金额:$27.93万
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财政年份:2001
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负责人:STEPHEN K TYRING
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依托单位:
EFFICACY OF HERPES SIMPLEX VACCINE--GD2T WITH MPL TO PREVENT GENITAL HERPES
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批准号:6566711
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项目类别:
-
资助金额:$27.93万
-
财政年份:2001
-
负责人:STEPHEN K TYRING
-
依托单位:
VALACYCLOVIR THERAPY OF SHINGLES IN IMMUNOCOMPETENT PATIENTS
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批准号:6413652
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项目类别:
-
资助金额:$27.93万
-
财政年份:2000
-
负责人:STEPHEN K TYRING
-
依托单位:
STUDY OF ORAL LOBUCAVIR IN PATIENTS WITH RECURRENT GENITAL HERPES
-
批准号:6413651
-
项目类别:
-
资助金额:$27.93万
-
财政年份:2000
-
负责人:STEPHEN K TYRING
-
依托单位:
EFFICACY OF HERPES SIMPLEX VACCINE--GD2T WITH MPL TO PREVENT GENITAL HERPES
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批准号:6413650
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项目类别:
-
资助金额:$27.93万
-
财政年份:2000
-
负责人:STEPHEN K TYRING
-
依托单位:
ABT 606 VS ACYCLOVIR FOR TREATMENT OF HERPES ZOSTER
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批准号:6413630
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项目类别:
-
资助金额:$27.93万
-
财政年份:2000
-
负责人:STEPHEN K TYRING
-
依托单位:
VALACYCLOVIR THERAPY OF SHINGLES IN IMMUNOCOMPROMISED PATIENTS
-
批准号:6413653
-
项目类别:
-
资助金额:$27.93万
-
财政年份:2000
-
负责人:STEPHEN K TYRING
-
依托单位:
VALACYCLOVIR THERAPY OF SHINGLES IN IMMUNOCOMPROMISED PATIENTS
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批准号:6305282
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项目类别:
-
资助金额:$3.42万
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财政年份:1999
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负责人:STEPHEN K TYRING
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依托单位:
STUDY OF ORAL LOBUCAVIR IN PATIENTS WITH RECURRENT GENITAL HERPES
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批准号:6305278
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项目类别:
-
资助金额:$3.42万
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财政年份:1999
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负责人:STEPHEN K TYRING
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依托单位:
ABT 606 VS ACYCLOVIR FOR TREATMENT OF HERPES ZOSTER
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批准号:6305248
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项目类别:
-
资助金额:$3.42万
-
财政年份:1999
-
负责人:STEPHEN K TYRING
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依托单位:
VALACYCLOVIR THERAPY OF SHINGLES IN IMMUNOCOMPETENT PATIENTS
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批准号:6305280
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项目类别:
-
资助金额:$3.42万
-
财政年份:1999
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负责人:STEPHEN K TYRING
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依托单位:
EFFICACY OF HERPES SIMPLEX VACCINE--GD2T WITH MPL TO PREVENT GENITAL HERPES
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批准号:6305275
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项目类别:
-
资助金额:$3.42万
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财政年份:1999
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负责人:STEPHEN K TYRING
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依托单位:
STUDY OF ORAL LOBUCAVIR IN PATIENTS WITH RECURRENT HERPES LABIALIS
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批准号:6115203
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项目类别:
-
资助金额:$3.42万
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财政年份:1998
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负责人:STEPHEN K TYRING
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依托单位:
VALACYCLOVIR THERAPY OF SHINGLES IN IMMUNOCOMPETENT PATIENTS
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批准号:6115204
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项目类别:
-
资助金额:$3.42万
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财政年份:1998
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负责人:STEPHEN K TYRING
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依托单位:
VALACYCLOVIR THERAPY OF SHINGLES IN IMMUNOCOMPROMISED PATIENTS
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批准号:6115206
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项目类别:
-
资助金额:$3.42万
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财政年份:1998
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负责人:STEPHEN K TYRING
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依托单位:
EFFICACY OF HERPES SIMPLEX VACCINE--GD2T WITH MPL TO PREVENT GENITAL HERPES
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批准号:6115197
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项目类别:
-
资助金额:$3.42万
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财政年份:1998
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负责人:STEPHEN K TYRING
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依托单位: