An International, Randomized, Double-Blind, Placebo-Controlled Study of Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons With CD4+ Lymphocyte Count <100 Cells/mm3.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
This clinical research study will be an international trial evaluating the safety and effectiveness of a marketed drug compared to placebo (like a sugar pill) for the suppression of repeated genital herpes infections in HIV-infected subjects with CD4+ count <100 cells/mm3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- 否
入选标准
- •CD4+ lymphocyte count <100cells/mm3 at the screening visit.
- •Documented history of HIV infections
- •Must have received stable, combination anti HIV drugs for at least 4 months immediately prior to participation, and per the investigator, are unlikely to require change in anti-HIV drugs during the six-month study.
- •Laboratory confirmation of genital herpes (a positive Herpes Simplex Virus-2 antibody test).
- •3 or more outbreaks of genital herpes in the previous 12 months if not on genital herpes medicines currently.
- •3 or more outbreaks of genital herpes per year in the period prior to beginning of treatment for chronic genital herpes.
排除标准
- •Kidney diseases.
- •Liver diseases.
- •Known allergic reactions to VALTREX (valaciclovir), ZOVIRAX (acyclovir), FAMVIR (famciclovir), or CYTOVENE (ganciclovir).
- •Vomiting syndrome.
- •Must be willing to discontinue taking current genital herpes medicines 1 week prior to participation.
- •Active AIDS-indicator conditions, as defined by CDC Category C.
- •Other protocol inclusion and exclusion criteria to be evaluated by the research physician.
研究组 & 干预措施
Suppressive + Episodic Therapy
Valaciclovir (VAL) 500mg twice daily for 6 months, and episodic treatment with VAL 1000mg twice daily for 5 days or 10 days, when required for treatment of a genital herpes recurrence.
干预措施: valacyclovir hydrochloride (Drug)
Episodic Therapy
Matching placebo twice daily for 6 months, and episodic treatment with VAL 1000mg twice daily for 5 or 10 days, when required for treatment of a genital herpes recurrence.
干预措施: valacyclovir hydrochloride (Drug)
结局指标
主要结局
Adverse Events
时间窗: Up to 6 months
The nature and incidence of adverse events, by treatment group, reported during the 6-month study will be summarized.
次要结局
- Proportion of recurrence of genital HSV(Up to 6 months)
- Time to first culture-positive recurrence of genital HSV(Up to 6 months)