Acyclovir Therapy for Genital Herpes Ulcers in HIV Negative African Women
2017年9月13日 更新者：University of North Carolina, Chapel Hill
Prospective Study of Pharmacokinetics, Clinical and Virologic Response to Acyclovir Episodic Therapy for Genital Herpes Ulcers in HIV Negative African Women
This is a prospective study to evaluate the pharmacokinetics, clinical and virologic response to acyclovir episodic therapy for genital herpes ulcers in HIV negative African women.
研究概览
详细说明
This is a two-part study designed to measure the Area Under the Curve (AUC) from a single dose of acyclovir 400mg in 60 African HIV-negative heterosexual women who have a history of genital ulcer disease (GUD), are HSV-2 seropositive and HIV-1 seronegative.
The study will also examine the time to healing of genital lesion and duration of HSV shedding from GUD among 90 HIV negative African women who have a history of GUD and are Herpes Simplex Virus (HSV)-2 seropositive and HIV-1 seronegative randomized in a 2:1 ratio to receive episodic acyclovir or matching placebo.
研究类型
介入性
注册 (实际的)
74
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Lusaka、赞比亚
- Centre for Infectious Disease Research in Zambia
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 50年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- HIV negative as determined by concordant rapid testing
- HSV-2 seropositive (Focus HerpeSelect EIA >3.4)
- At least one prior occurrence of GUD
- 18 to 50 years of age
Exclusion Criteria:
- Current use, or use within the past 7 days, of acyclovir, valacyclovir, or famciclovir
- Prior hypersensitivity and/or allergic reaction to acyclovir
- Use of probenecid, which prolongs renal excretion of acyclovir
- Current use, or use within the past 28 days, of an investigational agent
- Currently pregnant or nursing
- Currently plan to become pregnant during the next 3 months
- Currently consume, on average, more than 7 drinks of alcohol per week (for Part I)
- Current use of more than 20 cigarettes daily (for Part I)
- Any condition that in the opinion of the investigator will interfere with successful completion of all study procedures.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Part 1 PK
400mg dose of acyclovir taken orally, followed by 2 ml blood plasma collection at 1,2,4,6 and 8 hours.
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Single dose of acyclovir 200mg was given for pk study
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有源比较器：Acyclovir
400 mg Acyclovir three times daily for 5 days
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Single dose of acyclovir 200mg was given for pk study
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安慰剂比较：Placebo
Placebo three times daily for 5 days
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Area under the Curve (AUC)
大体时间：0, 2, 3, 4, 6 and 8 hours post acyclovir administration
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Blood will be drawn for pharmacokinetic measures to determine whether there is a difference in African women vs. the existing AUC data for women and men in North America and Europe.
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0, 2, 3, 4, 6 and 8 hours post acyclovir administration
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time to re-epithelization and time to cessation of HSV shedding
大体时间：days 1-5, 7, 9, 11 and 13
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Daily assessment of response of genital lesions over 13 days by time to healing and duration of HSV shedding during acyclovir 400mg orally three times daily versus placebo three times daily for 5 days.
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days 1-5, 7, 9, 11 and 13
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Stewart Reid, MD、Centre for Infectious Disease Research in Zambia
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Steingrimsdottir H, Gruber A, Palm C, Grimfors G, Kalin M, Eksborg S. Bioavailability of aciclovir after oral administration of aciclovir and its prodrug valaciclovir to patients with leukopenia after chemotherapy. Antimicrob Agents Chemother. 2000 Jan;44(1):207-9. doi: 10.1128/AAC.44.1.207-209.2000.
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年1月1日
初级完成 (实际的)
2009年12月1日
研究完成 (实际的)
2009年12月1日
研究注册日期
首次提交
2014年1月31日
首先提交符合 QC 标准的
2014年1月31日
首次发布 (估计)
2014年2月3日
研究记录更新
最后更新发布 (实际的)
2017年9月15日
上次提交的符合 QC 标准的更新
2017年9月13日
最后验证
2014年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.