A Randomized Controlled Crossover Trial of Acylcovir Among HIV and HSV-2 Co-Infected Women, Chiang Rai, Thailand
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- To evaluate the effect of acyclovir suppressive therapy on HIV genital shedding.
研究概览
简要总结
Herpes infection is an important co-factor in HIV transmission. A recent meta-analysis demonstrated that HSV infection contributed to a 2-fold increased risk of HIV transmission. Suppressive therapy with acyclovir has been a method proposed to reduce HIV transmission. We are conducting a randomized controlled cross-over trial to evaluate the effect of acyclovir suppressive therapy on HIV genital shedding in women co-infected with HIV-1 and Herpes Simplex Virus Type-2 (HSV-2) in Thailand.
详细描述
65 women ages 18-49 years old with HIV-1 and HSV-2 co-infection are being recruited from general medicine clinics, family planning clinics, postnatal clinics, community based organizations and community outreach in Chiang Rai, Thailand.
Our study objectives are:
- To evaluate the effect of acyclovir suppressive therapy on HIV genital shedding.
- To determine the association between HIV and HSV genital shedding, and the effect of acyclovir suppressive therapy on this association.
- To determine the acceptability of acyclovir suppressive therapy for women with HIV infection.
- To evaluate the association of genital symptoms and HIV or HSV genital shedding.
- To evaluate the association between cervicovaginal (CVL) specimens and self-collected genital swabs for detection of HIV and HSV-2.
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
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •participants will be HIV and HSV-2 seropositive
排除标准
- •pregnancy, CD4 count <200, on ART
结局指标
主要结局
To evaluate the effect of acyclovir suppressive therapy on HIV genital shedding.
次要结局
- To determine the association between HIV and HSV genital shedding, and the effect of acyclovir suppressive therapy on this association.
- To determine the acceptability of acyclovir suppressive therapy for women with HIV infection.
- To evaluate the association of genital symptoms and HIV or HSV genital shedding.
- To evaluate the association between cervicovaginal (CVL) specimens and self-collected genital swabs for detection of HIV and HSV-2.