Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2
Genital Herpes
About this trial
This is an interventional treatment trial for Genital Herpes
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; 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
Sites / Locations
- University of Washington Virology Research Clinic
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Standard dose
High-dose