A Randomized,Double-Blind , Placebo-Controlled Crossover Trial of Antivirals for Suppression of HSV and HIV Shedding in HIV-1, HSV-2 Co-infected Persons
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Plasma HIV-1 levels and HIV-1 mucosal shedding
研究概览
简要总结
Over 80% of HIV-1 infected persons are also seropositive for HSV-2. Increasingly, clinical and epidemiologic evidence show the role of HSV in increasing HIV infectiousness. The evidence suggests that HSV is an important co-factor in HIV transmission.
The trial's purpose is to assess the reduction in HIV systemic and mucosal replication associated with valacyclovir for suppression of HSV-2 reactivation.
This randomized, double-blind, placebo controlled crossover trial of 20 HIV/HSV-2 co-infected women assessed the effects of daily valacyclovir on HIV-1 levels in blood and body fluids.
详细描述
Conducted in Lima Peru, 20 HIV-1 and HSV-2 seropositive women with CD4 counts greater than 200 and on no antiretroviral therapy were randomly assigned to receive valacyclovir 500 mg bid or placebo for the first 8 weeks of the study. After these 8 weeks, a 2-week washout period followed, which was then followed by the alternative regimen for 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Greater than 18 years old woman,
- •Documented HIV-1 seropositive,
- •CD4 count greater than 200,
- •Not on HIV antiretroviral therapy,
- •HSV-2 seropositive as determined by Focus EIA (IN >3.5)
- •Not intending to move out of the area for the duration of study participation.
- •Willing and able to:provide independent written informed consent;undergo clinical evaluations;take study drug as directed;adhere to follow-up schedule.
- •Bacterial STDs (symptomatic STD syndromes or laboratory-confirmed asymptomatic gonorrhea and syphilis) are treated within two weeks of study enrollment and random assignment.
排除标准
- •Women who meet any of the following criteria are not eligible for this study:
- •Known history of adverse reaction to valacyclovir, acyclovir or famciclovir;
- •Planned open label use of acyclovir, valacyclovir, or famciclovir
- •Known medical history of seizures
- •Known renal failure, serum creatinine >2.0mg/dl
- •Hematocrit < 30 %
研究组 & 干预措施
I
干预措施: Valacyclovir (Drug)
I
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Plasma HIV-1 levels and HIV-1 mucosal shedding
时间窗: 18 weeks
次要结局
- Mucosal HSV-2 shedding(18 weeks)
- Determine the temporal pattern of HIV shedding with respect to HSV-1 and HSV-2 reactivation;(18 weeks)