The Interaction of HSV-2 Co-infection in Veterans With Chronic Hepatitis C: the Effect of Valacyclovir on HCV Viral Load
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The number of study participants who experience adverse events while receiving valacyclovir.
研究概览
简要总结
This trial is to determine the safety of valacyclovir in persons with chronic hepatitis C and herpes simplex type 2 infection. Participants will be randomized to valacyclovir or matching placebo. After receiving the initial therapy for eight weeks, the participants will cross over to the alternate therapy for an additional eight weeks. Each treatment period will be separated by a two-week period of daily placebo. The hypothesis is that treatment with valacyclovir will result in a significant reduction in serum levels of hepatitis C virus ribonucleic acid.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of hepatitis C infection
- •Clinical diagnosis of herpes simplex type 2 infection
排除标准
- •HIV infection
- •Other forms of chronic liver disease
- •Chronic medical conditions
- •On immunosuppressive medications
结局指标
主要结局
The number of study participants who experience adverse events while receiving valacyclovir.
时间窗: 18 weeks
Tolerability assessments will be performed very two weeks while on study medications. Complete blood cell count, creatinine clearance and liver function tests will be performed every four weeks while on medications. Adverse events will be graded using the Division of AIDS Adverse Event Grading Table, Version 1.0, clarification August 2009. Based on previous clinical experience with valacyclovir, we expect the drug will be well-tolerated in patients with hepatitis C.
次要结局
- The effect of valacyclovir compared with placebo to serum levels of HCV RNA(18)
研究者
Wanda Hayes
Administrative Officer, Research and Development
G.V. (Sonny) Montgomery VA Medical Center