Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2
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 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 15-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 valacyclovir or acyclovir; you will receive both medications at some point during this study). There will be a total of 9 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Cross-Over Study to Evaluate the Suppressive Effect of High-Dose Acyclovir Versus Once Daily Valacyclovir on Herpes Simplex Virus Type 2 Genital Shedding in Herpes Simplex Virus-2 Seropositive Adults|
- Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]Participants were treated with both interventions in a cross-over study design. Shedding rates on each drug arm per participant were compared by Poisson regression.
- Frequency of Subclinical Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
- Frequency of Lesional Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per Day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
- Number of Herpes Recurrences, Defined Clinically as >=1 Successive Day on Which Genital Lesions Are Present, in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2006|
|Study Completion Date:||September 2011|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
|Active Comparator: Standard dose||
500 mg orally once daily for 7 weeks
Other Name: Valtrex
800 mg orally three times daily for 7 weeks
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 information will be recorded in the Case Report Form (CRF):
- Demographic Data: Date of birth, sex, marital status, education and race
- Previous antiviral medication taken
- History of sexually transmitted infections and sexual history.
Start of Study Visit (Day 0) and Day 14, 28, 42, 56, 70, 84, 98 and 105 Follow-Up Visits.
Eligible patients will return to clinic to be given study drug and a patient diary card on which to record concomitant medications, signs and symptoms, and adverse experiences. The investigator will instruct the patient on daily home viral sample collection, taking the study drug, and completing the diary card. The patient will be instructed to return to clinic in 2 weeks, +/- 2 days. Medication compliance will be assessed at each visit using pill counts.
Crossover Study Visit Prior To Washout Period (Day 49-55)
Participants will not be given study drug or placebo during the 7-day washout period.
Daily Home Viral Sample Collection
Participants will collect swabs from the genital mucosa four times per day and store the samples in PCR media with preprinted labels. Women will swab the cervicovaginal, vulvar and perianal areas, and men will swab the penile and perianal. Every two weeks, they will return the samples to the Virology Research Clinic when they present for additional study drug and assessment.
Final Study Visit (Day 105)
At the final study visit at Day 105 or for premature discontinuation, the investigator will perform the activities at the regular study visits, with the exception of the dispensation of study drug.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00362297
|United States, Washington|
|University of Washington Virology Research Clinic|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||Christine Johnston, MD||University of Washington|