A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborator: National Institutes of Health (NIH)
• Treatments: Acyclovir

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