A Randomized, Open-label, Crossover Trial of the Effect of High-dose Daily HSV-2 Suppressive Therapy on Plasma HIV-1 Levels Among HIV-1/HSV-2 Co-infected Persons
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Mean Level of HIV-1 RNA in Plasma of Participants While on Acyclovir or Valacyclovir.
研究概览
简要总结
The purpose of this study is to determine whether treating HSV-2 with either valacyclovir or acyclovir is more effective in suppressing HIV-1 virus levels in people co-infected with HIV-1 and HSV-2.
详细描述
Sexual transmission is responsible for the vast majority of HIV-1 infections among adults worldwide. In sub-Saharan Africa, the region hardest hit by the HIV-1 epidemic, HSV-2 prevalences of 30-50% have been seen in the general population with prevalence up to 90% in infected with HIV-1. HSV-2 is common in those with, or at risk for, HIV-1 infection, and HSV-2 reactivation increases HIV-1 acquisition and infectiousness. Recent studies have shown that suppression of HSV-2 has a sustained effect on lowering HIV-1 levels in blood plasma. New data have raised the question whether higher doses of HSV-2 suppressive therapy might be more effective at suppressing HIV-1 levels. Acyclovir and valacyclovir, chosen for use in this study, are safe and effective treatments for decreasing the frequency of HSV-2 reactivation and shedding. The standard dose of acyclovir is 400 mg twice a day. Valacyclovir, a drug that converts to acyclovir after absorption, delivers higher concentrations of acyclovir. 1.5 grams of valacyclovir, will be used to provide a higher dose of acyclovir, and will be compared with the standard dose of 400 mg twice a day of acyclovir.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •HIV-1 seropositive
- •Not on HIV-1 antiretroviral therapy nor planning to initiate antiretroviral therapy during the study period
- •CD4 cell count >250 cell/µL
- •Not otherwise eligible for antiretroviral therapy according to Uganda national guidelines
- •Detectable HIV-1 plasma viral load
- •HSV-2 seropositive
- •Not intending to move out of the area for the duration of study participation.
- •Able to participate in the study at the Partners in Prevention site in Thika, Kenya
排除标准
- •Known history of adverse reaction to acyclovir, valacyclovir, or famciclovir.
- •Planned use of acyclovir, valacyclovir, or famciclovir
- •Use of ganciclovir, foscarnet, or cidofovir
- •Known medical history of seizures
- •Serum creatinine >1.5 mg/dL
- •AST or ALT >3 times upper limit of normal
- •Hematocrit <30 %
- •Absolute neutrophil count <1000
- •Platelet count <75,000
- •History of thrombotic microangiopathy
- •Any other condition which, in the opinion of the principal investigator, may compromise the ability to follow study procedures and complete the study
- •Participation in another HIV therapeutics trial
- •For women, pregnancy as confirmed by a urine pregnancy test
研究组 & 干预措施
acyclovir
acyclovir 400 mg orally twice daily
干预措施: acyclovir (Drug)
valacyclovir
valacyclovir 1.5 g orally twice daily
干预措施: valacyclovir (Drug)
结局指标
主要结局
Mean Level of HIV-1 RNA in Plasma of Participants While on Acyclovir or Valacyclovir.
时间窗: Weekly for 12 weeks per intervention
Mean level of HIV-1 RNA in plasma of participants while on 400 mg twice daily of acyclovir versus while on 1.5 g twice daily of valacyclovir.
次要结局
- Safety of Valacyclovir 1.5 Gram Orally Twice Daily in HIV-1 Seropositive Persons.(28 weeks)
研究者
Connie Celum
US Principal Investigator
University of Washington