A Randomized, Double-blind, Placebo-controlled Crossover Trial of Acyclovir for Suppression of HSV and HIV Shedding in HIV-1, HSV-2 Coinfected Persons in Cameroon
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- HSV and HIV viral shedding
研究概览
简要总结
The study proposed that both clinical and subclinical HSV reactivation is associated with increased HIV shedding from mucosal surfaces, which may increase the infectiousness of HIV-1/HSV-2 coinfected persons. To test this hypothesis, we will control HSV reactivation with acyclovir, a safe medication that is proven to reduce HSV shedding, and measure HIV levels in blood, genital, and pharyngeal secretions. The study hypothesizes that acyclovir will reduce HIV shedding from mucosal surfaces of HIV-1/HSV-2 coinfected individuals.
详细描述
The main objective is to assess the reduction in genital HIV-1 shedding associated with daily acyclovir for suppression of HSV-2 reactivation.
All patients will be treated with the usual antibiotic treatment for any sexually transmitted infections that are diagnosed during the study. In addition, half will receive acyclovir for 8 weeks , whilst the other half will receive a placebo for 8 weeks. The study medication will reverse in the second 8 weeks of the study. The patients will attend the clinic 3 times per week during the first and the last 8 weeks of the study and once every week during the washout period in the middle of the study - for a total of 18 weeks per participant. At each visit genital and oral samples will be collected. A blood sample will also be collected. For women participants, pregnancy test will be performed. The clinic will provide both pre- and post-HIV test counseling.
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
- Double (Participant, Investigator)
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
- •18 years old and above
- •Documented HIV-seropositive
- •HSV-2 seropositive as determined by Focus EIA
- •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, chlamydia, syphilis) are treated within two weeks if 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 acyclovir
- •Planned open label use of acyclovir, valacyclovir, or famciclovir
- •Positive pregnancy test
- •Active opportunistic infection
研究组 & 干预措施
1
Acyclovir 800 mg twice daily for 8 weeks, two week washout, 8 weeks placebo
干预措施: Acyclovir (Drug)
2
8 weeks placebo, 2 week washout, 8 weeks 800 mg acyclovir twice daily
干预措施: Acyclovir (Drug)
结局指标
主要结局
HSV and HIV viral shedding
时间窗: 18 weeks
次要结局
- HSV suppression and HIV shedding(18 weeks)