Status:
COMPLETED
Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2
Lead Sponsor:
University of Washington
Conditions:
Genital Herpes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 s...
Detailed Description
Screening Assessment Patients will be assessed for their eligibility to enter the study at a screening visit. After signing informed consent they will undergo a medical history and the following info...
Eligibility Criteria
Inclusion
- 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
- hypersensitivity to acyclovir or valacyclovir;
- pregnant women;
- HIV positive or other immunosuppressed state, including chronic steroid use. Intermittent nasal or topical steroids are acceptable
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00362297
Start Date
September 1 2006
End Date
September 1 2011
Last Update
November 18 2021
Active Locations (1)
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1
University of Washington Virology Research Clinic
Seattle, Washington, United States, 98104