A Randomized, Cross-Over Study to Evaluate the Suppressive Effect of Acyclovir on Rapidly Cleared Herpes Simplex Virus Type 2 Genital Reactivation Episodes in Herpes Simplex Virus-2 Seropositive Adults
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With Suppressive Acyclovir as Compared to no Medication in HIV Seronegative and HIV Seropositive Individuals.
研究概览
简要总结
We propose to study the episode rate, duration, and quantity of HSV-2 genital shedding in patients taking standard, FDA approved, CDC recommended doses of acyclovir (400 mg PO BID) for HSV-2 suppression compared to taking no medication to better define the effect of acyclovir on short bursts of rapidly cleared HSV-2 shedding. This study will be a randomized, open label, cross-over trial. We hypothesize that short bursts of HSV-2 reactivation will not be suppressed by acyclovir.
详细描述
We propose to study the episode rate, duration, and quantity of HSV-2 genital shedding in patients taking standard, FDA approved, CDC recommended doses of acyclovir (400 mg PO BID) for HSV-2 suppression compared to taking no medication to better define the effect of acyclovir on short bursts of rapidly cleared HSV-2 shedding. This study will be a randomized, open label, cross-over trial.
We propose to perform this study in two study populations. Cohort 1 will be comprised of 25 HSV-2 seropositive, HIV seronegative adults, and Cohort 2 will be comprised of 25 HSV-2 seropositive, HIV seropositive adults with a CD4 count>250 cells/mm3. As suppression of HSV-2 using acyclovir is currently being studied in large, multi-center, international clinical trials as an HIV prevention strategy, these results will have broad implications for public health around the world.
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
- •COHORT 1: HIV seronegative
- •Older than 18 years;
- •HSV-2 seropositive by Western Blot;
- •not receiving any drugs with known anti-HSV-2 activity for study duration;
- •women of child bearing potential who are sexually active with men must be using a medically accepted method of contraception as judged by the investigator;
- •women of child-bearing potential must have a negative pregnancy test (urine) at screening visit;
- •in general good health, without other serious medical conditions and specifically with normal renal and hepatic function, as determined by the patient's medical history;
- •planning to remain resident in the area of the study center for the duration of the study participation;
- •HIV seronegative
- •COHORT 2: HIV seropositive
- •Older than18 years;
- •HSV-2 seropositive by Western Blot;
- •not receiving any drugs with known anti-HSV-2 activity for study duration;
- •women of child bearing potential who are sexually active with men must be using a medically accepted method of contraception as judged by the investigator;
- •women of child-bearing potential must have a negative pregnancy test (urine) at screening visit;
- •in general good health, without other serious medical conditions and specifically with normal renal and hepatic function, as determined by the patient's medical history;
- •planning to remain resident in the area of the study center for the duration of the study participation;
- •HIV seropositive
- •CD4 count over 250 cell/mm3
- •Not taking antiretroviral therapy
排除标准
- •For both cohorts:
- •hypersensitivity to acyclovir or valacyclovir;
- •pregnant women;
- •Taking immunosuppressive therapies, such as chronic oral steroids or immune modulatory drugs.
- •For cohort 2:
- •CD4 count<250 cell/mm3
- •Taking antiretroviral therapy at the time of study entry
研究组 & 干预措施
1
干预措施: acyclovir (Drug)
结局指标
主要结局
Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With Suppressive Acyclovir as Compared to no Medication in HIV Seronegative and HIV Seropositive Individuals.
时间窗: 9 weeks
次要结局
- Quantity of HSV Detected, Median(9 weeks)
- Number of Genital HSV Shedding Episodes(9 weeks)
- Duration of Genital HSV Shedding Episodes(9 weeks)
研究者
Christine Johnston
Principal Investigator
University of Washington