A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation
Condition: Genital Herpes
MeSH terms: Herpes Genitalis
Intervention: acyclovir
Intervention description: Acyclovir 400 mg PO BID for 28 days
Intervention MeSH terms: Acyclovir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

        COHORT 1: HIV seronegative

          1. Older than 18 years;

          2. HSV-2 seropositive by Western Blot;

          3. not receiving any drugs with known anti-HSV-2 activity for study duration;

          4. 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;

          5. women of child-bearing potential must have a negative pregnancy test (urine) at
             screening visit;

          6. 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;

          7. planning to remain resident in the area of the study center for the duration of the
             study participation;

          8. HIV seronegative

        COHORT 2: HIV seropositive

          1. Older than18 years;

          2. HSV-2 seropositive by Western Blot;

          3. not receiving any drugs with known anti-HSV-2 activity for study duration;

          4. 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;

          5. women of child-bearing potential must have a negative pregnancy test (urine) at
             screening visit;

          6. 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;

          7. planning to remain resident in the area of the study center for the duration of the
             study participation;

          8. HIV seropositive

          9. CD4 count over 250 cell/mm3

         10. Not taking antiretroviral therapy

        Exclusion Criteria:

        For both cohorts:

          1. hypersensitivity to acyclovir or valacyclovir;

          2. pregnant women;

          3. Taking immunosuppressive therapies, such as chronic oral steroids or immune modulatory
             drugs.

        For cohort 2:

          1. CD4 count<250 cell/mm3

          2. Taking antiretroviral therapy at the time of study entry