Prospective Study of Pharmacokinetics, Clinical and Virologic Response to Acyclovir Episodic Therapy for Genital Herpes Ulcers in HIV Negative African Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Area under the Curve (AUC)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Part 1 PK
400mg dose of acyclovir taken orally, followed by 2 ml blood plasma collection at 1,2,4,6 and 8 hours.
干预措施: Acyclovir (Drug)
Acyclovir
400 mg Acyclovir three times daily for 5 days
干预措施: Acyclovir (Drug)
Placebo
Placebo three times daily for 5 days
干预措施: Placebo (Drug)
结局指标
主要结局
Area under the Curve (AUC)
时间窗: 0, 2, 3, 4, 6 and 8 hours post acyclovir administration
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.
次要结局
- Time to re-epithelization and time to cessation of HSV shedding(days 1-5, 7, 9, 11 and 13)