NCT00002404已完成不适用
The Effect of Treatment With Valacyclovir 500 mg BID on the Detection of HIV From Genital HSV Lesions in HIV-Infected Patients: A Double-Blind Crossover Study
Glaxo Wellcome0 个研究点目标入组 30 人开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
The purpose of this study is to see if valacyclovir affects the detection of HIV in genital herpes lesions in HIV-infected patients. Valacyclovir is used to treat recurrent genital herpes.
详细描述
Following evaluation for 2 consecutive episodes of genital herpes in this double-blind, crossover study, 30 HIV-1 positive patients are randomized to receive either valacyclovir or placebo.
All patients are treated for 10 days.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •Serologically documented HSV-2 and HIV-1 infection.
- •History of recurrent genital herpes that presents at least 3 recurrences within the 12 months prior to the start of study.
- •No contraindications to valacyclovir.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Hepatic impairment.
- •Impaired renal function (creatinine above 2 mg/dl).
- •Malabsorption syndrome or other gastrointestinal dysfunction.
- •Any other condition that in the investigator's opinion would interfere with study procedures or successful completion of protocol.
- •Patients with the following prior conditions are excluded:
- •History of hypersensitivity to acyclovir or valacyclovir.
- •Prior Medication:
- •Participation in any investigational drug trial within 1 month prior to entry on study.
- •Systemic anti-HSV therapy within 7 days prior to start of study drug.
- •1. Probenecid.
- •Suppressive treatment with medication that has anti-HSV activity.
- •- Stable antiretroviral therapy or no therapy for at least 1 month.
研究者
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