Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2
Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
Participant gender:
Summary
The purpose of the research study is to evaluate the effectiveness of high-dose acyclovir
compared to valacyclovir for reduction of asymptomatic genital shedding in persons with
genital herpes.
The study will enroll men and women who are 18 years or older, test positive to HSV-2 (by
blood test) and have had a first outbreak of HSV-2 within the past 6 months or have had at
least 4 genital herpes outbreaks in the past year. Participants must be HIV negative and
willing to stop taking suppressive therapy for HSV for the one week wash out period. (Females
only: You must not be pregnant or breast-feeding). Both men and women will be asked to use an
effective form of birth control.
Involvement in the study will last 15-weeks and you will be asked to visit the clinic every
2-weeks. At each visit, you will be given medication to take daily (either valacyclovir or
acyclovir; you will receive both medications at some point during this study). There will be
a total of 9 study visits and each visit will last approximately 30 minutes. We will ask that
you complete a daily symptom diary and collected daily home swabs 4-times a day, everyday
during the study. Each daily home swab will take less than 3 minutes to perform.