NCT01154543已完成不适用
A Single Center, Open Label, Longitudinal Single Arm Study to Compare the Efficacy and Safety of Prophylactic Famciclovir 500 mg b.d. in HIV Positive Adults With Recurrent Genital Herpes.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- To determine the incidence of acute genital HSV outbreaks whilst taking Famciclovir 500 mg bd during the study period (24 months)
研究概览
简要总结
To determine the efficacy of Famvir 500mg bd as suppressive antiviral therapy for acute genital Herpes simplex virus (HSV) outbreaks in HIV subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide signed informed consent
- •Documented HIV infection
- •In general good health, without other serious medical conditions as deemed by the investigator
- •Male or female over 18 years of age
- •Diagnosed genital HSV (clinical or laboratory)
- •Life expectancy of 12 months or longer per investigator's judgment
- •Stable on Famvir 500 mg bd for at least 30 days at time of screening
排除标准
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>5)mIU/mL).
- •Women of childbearing potential who are unwilling to use reliable contraception for the duration of the study.
- •History of hypersensitivity to Famvir, its constituents or penciclovir
- •Current use of another antiherpetic medication
- •Recent history of alcohol or drug abuse, which in the opinion of the investigator may interfere with their compliance with study requirements, or who have any other conditions which in the opinion of the investigator would interfere with the successful completion of study procedures
- •Disorder or condition that could interfere with drug absorption, distribution, metabolism or excretion
- •Known or suspected to have or past history of renal dysfunction requiring a dosage modification of Famvir 500 bd
结局指标
主要结局
To determine the incidence of acute genital HSV outbreaks whilst taking Famciclovir 500 mg bd during the study period (24 months)
时间窗: 24 months
To determine the incidence of acute genital HSV outbreaks whilst taking Famciclovir 500 mg bd during the study period (24 months)and to determine the safety of Famciclovir 500mg bd in this population
次要结局
- To determine the acceptability of Famciclovir 500 mg bd as long term suppressive antiviral therapy(24 months)
研究者
Dr. Mark Bloch
Dr Mark Bloch
Holdsworth House Medical Practice
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