Randomized Trial to Evaluate Suppressive Effect of High-Dose Valacyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2
Condition: Genital Herpes
MeSH terms: Herpes Genitalis
Intervention: valacyclovir; Valacyclovir
Intervention description: 1000 mg orally three times daily for 5 weeks; 500 mg orally once daily for 5 weeks
Intervention MeSH terms: Valacyclovir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      On 13 August 2008, this trial was submitted to ClinicalTrials.gov as modification to
      NCT00362297. On 28 April 2011, the two records were split for administrative purposes and
      each trial was given its own unique study record. Please refer to the "History of Changes" on
      posting NCT00362297 for a detailed summary of the modifications.

      The purpose of the research study is to evaluate the effectiveness of high-dose valacyclovir
      compared to once daily valacyclovir for reduction of asymptomatic HSV-2 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 11-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 once daily
      valacyclovir or high dose valacyclovir; you will receive both medications at some point
      during this study). We will ask you to give a blood sample for liver, kidney and blood count
      testing at each visit. There will be a total of 8 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:

          -  18 years or older;

          -  HSV-2 seropositive by Western Blot;

          -  not receiving any drugs with known anti-HSV-2 activity for study duration;

          -  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; or shedding HSV-2 from genital
             mucosa on >25% of days in shedding session performed at the VRC within the last 2
             years.

          -  able to comply with the study protocol;

          -  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.

        Exclusion Criteria:

          -  hypersensitivity to acyclovir or valacyclovir;

          -  pregnant women;

          -  HIV positive or other immunosuppressed state, including chronic steroid use.
             Intermittent nasal or topical steroids are acceptable