Half-life and Pattern of Resolution of Herpes Simplex Virus Type 2 (HSV-2) Shedding After Beginning Acyclovir Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To calculate the half-life of detectable HSV-2 DNA in genital mucosa during a clinical recurrence of genital herpes, after treatment with acyclovir has begun.
研究概览
简要总结
The purpose of the study is to evaluate the pattern of viral shedding after beginning treatment with acyclovir for a clinical recurrence of genital herpes and to compare it with the pattern of viral shedding during an untreated clinical recurrence of genital herpes.
详细描述
The purpose of the study is to evaluate the pattern of viral shedding after beginning treatment with acyclovir for a clinical recurrence of genital herpes and to compare it with the pattern of viral shedding during an untreated clinical recurrence of genital herpes.
Participants are asked to visit the University of Washington Virology Research Clinic for an initial screening appointment in which the clinician will ensure eligibility and informed consent will be obtained.
Participants who experience an outbreak during the next year will be asked to call the clinic at the beginning of their next outbreak. The clinician will arrange to admit the participant to the UW General Clinical Research Center (GCRC) for a 5-day hospitalization stay. During hospitalization, participants will take acyclovir (400mg 3 times daily) and genital swabs will be collected every 2 hours during the day and every 4 hours at night for 5 days. After the last swab has been taken, the study nurse at the GCRC will do a final genital exam and the participant will be discharged. Some participants will also be asked to enroll in a control arm during which the same procedures will be followed except they will not take acyclovir during the recurrence.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Age 18 years or older
- •History of clinically-evident genital herpes
- •3 or more clinical genital herpes recurrences within the prior 12 months
- •HSV-2 seropositive by HSV Western Blot
- •Willing and able to comply with study protocol
排除标准
- •Pregnancy
- •Taking daily antiviral therapy for genital herpes
- •HIV seropositive or known immunocompromising medical condition
- •Plan to move from the Seattle area within the next year
- •Hypersensitivity to or intolerance of acyclovir
研究组 & 干预措施
1
HSV-2 seropositive subjects who will receive a 5-day course of acyclovir for treatment of a genital herpes recurrence.
干预措施: acyclovir (Drug)
结局指标
主要结局
To calculate the half-life of detectable HSV-2 DNA in genital mucosa during a clinical recurrence of genital herpes, after treatment with acyclovir has begun.
时间窗: 5 days
次要结局
- To describe the time course, diurnal variation, and pattern of resolution of HSV-2 shedding during both acyclovir-treated and untreated clinical recurrences of genital herpes.(5 days)
研究者
Anna Wald
Principal Investigator
University of Washington