Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2
Condition: Genital Herpes
MeSH terms: Herpes Genitalis
Intervention: acyclovir; valacyclovir
Intervention description: 800 mg orally three times daily for 7 weeks; 500 mg orally once daily for 7 weeks
Intervention MeSH terms: Valacyclovir; Acyclovir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years or older;

          2. HSV-2 seropositive by Western Blot;

          3. not receiving any drugs with known anti-HSV-2 activity for study duration;

          4. history of primary genital herpes infection within past 6 months OR history of 4 or
             more HSV recurrences per year during the past year OR 4 or more recurrences per year
             prior to initiation of suppressive antiviral therapy;

          5. able to comply with the study protocol;

          6. 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;

          7. women of child-bearing potential must have a negative pregnancy test (urine) at
             screening visit;

          8. 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;

          9. planning to remain resident in the area of the study center for the duration of the
             study participation;

         10. HIV seronegative.

        Exclusion Criteria:

          1. hypersensitivity to acyclovir or valacyclovir;

          2. pregnant women;

          3. HIV positive or other immunosuppressed state, including chronic steroid use.
             Intermittent nasal or topical steroids are acceptable